History of database changes

10 June, 2026 (Version: 20260610AU) (Latest version)

New Zanidatamab + Tislelizumab + Capecitabine + Oxaliplatin, Zanidatamab + Capecitabine + Oxaliplatin in Gastric cancer, Gastroesophageal adenocarcinoma with ERBB2 Overexpression, Amplification: 2

Phase 3 HERIZON-GEA-01. NCT05152147. N=914. Zanidatamab + tislelizumab + chemo improved PFS over trastuzumab + chemo (12.4 vs 8.1 months, HR 0.63). Zanidatamab + chemo improved PFS (12.4 vs 8.1 months, HR 0.65). OS was improved for zanidatamab + tislelizumab + chemo (26.4 vs 19.2 months, HR 0.72). OS for zanidatamab + chemo (24.4 months) did not meet significance (HR 0.80, p=0.06). ORR: 70.7%, 69.6%, and 65.7%. Median DOR: 20.7, 14.3, and 8.3 months. References: 42202319

08 June, 2026 (Version: 20260608AU)

New Pembrolizumab in Intrahepatic cholangiocarcinoma with Microsatellite Instability High: 4

Case report. MSI-H intrahepatic cholangiocarcinoma. Pembrolizumab resulted in rapid tumor shrinkage sustained for 30 months. References: 40032770

New Sacituzumab Tirumotecan + Pembrolizumab in Non-small cell lung cancer with CD274 Protein expression: 4

Phase 3 OptiTROP-Lung05. NCT06448312. N=413. Sac-TMT plus pembrolizumab significantly improved PFS over pembrolizumab (median not reached vs 5.7 months; HR 0.35). ORR was 70.2% vs 42.0%. In PD-L1 TPS 1-49% subgroup, PFS HR 0.28; in TPS ≥50% subgroup, PFS HR 0.47. In non-squamous histology, PFS HR 0.28; in squamous, PFS HR 0.44. OS trend favored sac-TMT plus pembrolizumab (HR 0.55). References: 42214392, 10.1200/JCO.2026.44.16_suppl.8506

New Neladalkib in Non-small cell lung cancer with ALK Fusion, G1202R: 3

Phase 1/2 ALKOVE-1. NCT05384626. N=656. Neladalkib in ALK+ NSCLC. TKI pre-treated (n=253): ORR 31%, DOR at 12m 64% and 18m 53%, Intracranial (IC)-ORR 32%. Lorlatinib-naive subset: ORR 46%, DOR at 12m 80%, IC-ORR 63%. G1202R mutation: ORR 68%, DOR at 12m 80%. TKI-naive preliminary (n=44): ORR 86%, 12m DOR 91%, IC-ORR 78%. References: 10.1200/JCO.2026.44.16_suppl.8503

Changed Pembrolizumab in Solid tumours with Microsatellite Instability High: 1B

Comments changed: TGA provisional approval for MSI-H/dMMR. FDA approved. In phase 2 KEYNOTE-158. NCT02628067. N=233. Noncolorectal MSI-H/dMMR advanced cancer. ORR 34.3%. Median PFS 4.1 months. Median OS 23.5 months. In phase . NCT01876511, N=41. Immune-related ORR was 40% in dMMR colorectal vs 0% in pMMR colorectal. Immune-related 20-week PFS rate was 78% in dMMR vs 11% in pMMR colorectal. Median PFS and OS not reached in dMMR colorectal vs 2.2 and 5.0 months in pMMR colorectal. dMMR non-colorectal had ORR 71% and PFS rate 67%.. (First curated: 2020-12-10)

Changed Setidegrasib in Non-small cell lung cancer, Pancreatic adenocarcinoma with KRAS G12D: 3

References changed: 41879829, 10.1016/j.annonc.2024.08.675. (First curated: 2026-04-12)

Changed Therapy in Solid tumours with KRAS G12D: 3

Therapy changed: SetidegrasibASP3082. (First curated: 2024-09-15)

Changed Therapy in Non-small cell lung cancer, Pancreatic adenocarcinoma, Colorectal adenocarcinoma with KRAS G12, G12D, G12V, G12C, G12A, G12S: 4

Therapy changed: DaraxonrasibRMC-6236. (First curated: 2025-05-24)

Changed Therapy in Pancreatic adenocarcinoma, Non-small cell lung cancer with KRAS G12, G12D, G12V, G12R, G12D, G12V, G12A: 4

Therapy changed: DaraxonrasibRMC-6236. (First curated: 2023-10-30)

Changed Therapy in Non-small cell lung cancer with RRAS Q87L: 4

Therapy changed: DaraxonrasibRMC-6236. (First curated: 2026-05-07)

Changed Therapy in Non-small cell lung cancer with RRAS2 Q72L: 4

Therapy changed: DaraxonrasibRMC-6236. (First curated: 2026-05-07)

07 June, 2026 (Version: 20260607AU)

New ALK201 in Solid tumours with FGFR2 FGFR2b Overexpression, FGFR2-IIIb Overexpression: 4

Phase 1/2. NCT06656390. N=38. ALK201 showed ORR of 24% and DCR of 68% in evaluable patients (n=25); at ≥7.2 mg/kg, ORR was 35.7% and DCR was 100%. In IHC2+/3+ in >=5% of cells, ORR was 27%.(n=11). References: 10.1200/JCO.2026.44.16_suppl.3025

New MRG006A in Hepatocellular carcinoma with GPC3 Protein expression, Overexpression: 4

Phase 1/2 MRG006A-001. NCT07093970. N=26. ORR 23.1% (33.3% in high GPC3 expression). DCR 68.0% (75.0% in high GPC3). CBR 32.0% (50.0% in high GPC3). Median PFS 7.0 months. Median DOR 4.2 months. References: 10.1200/JCO.2026.44.16_suppl.3028

New BL-M05D1 in Pancreatic cancer, Gastric cancer, Gastroesophageal adenocarcinoma, Biliary tract cancer with CLDN18 Protein expression: 4

Phase 1. NCT06349811. BL-M05D1 in CLDN18.2+ solid tumors. At 4.0 mg/kg: Pancreatic cancer ORR 35.7%, mPFS 5.6 months; Gastric cancer ORR 39.2%, mPFS 5.4 months; Biliary tract cancer ORR 37.9%, mPFS 5.9 months. Second-line Pancreatic cancer ORR 50.0%, mPFS 5.7 months; Gastric cancer ORR 44.8%, mPFS 7.7 months; Biliary tract cancer ORR 45.0%, mPFS 5.9 months. DCR 89-93%. References: 10.1200/JCO.2026.44.16_suppl.3030

New TQB6411 in Non-small cell lung cancer with EGFR Exon 19 deletion, L858R: 4

Phase 1. NCT07043751. N=26. TQB6411 in advanced solid tumors. ORR 50.0% (4/8) in ≥4mg/kg dose group (PR: 3 NSCLC, 1 EC). DCR 100%. References: 10.1200/JCO.2026.44.16_suppl.3032

New EBC-129 in Gastric cancer, Gastroesophageal adenocarcinoma with CEACAM5 Protein expression, Overexpression: 4

Phase 1. NCT05701527. N=21 (17 evaluable). Overall ORR 29.4%, DCR 82.4%, median PFS 17.86 weeks in IHC ≥20% at IHC 2+/3+. In IHC ≥50% subgroup, ORR 50%, DCR 90%, median PFS 21.4 weeks. At 1.8 mg/kg with IHC ≥50%, ORR 50%, DCR 100%, median PFS 29.2 weeks. References: 10.1200/JCO.2026.44.16_suppl.3033

06 June, 2026 (Version: 20260606AU)

New QLS31905 + Gemcitabine + Nab-paclitaxel, QLS31905 + Oxaliplatin + Capecitabine in Pancreatic cancer, Gastric cancer with CLDN18 Protein expression: 3

Phase 1b/2 trial. NCT06041035. N=131 (88 PC, 43 GC). RP2D 800 mg/kg Q3W. In PC: ORR 59.8%, DCR 89.0%, median PFS 8.7 months, median DoR 8.9 months, median OS 15.9 months. In GC: ORR 74.4%, DCR 93.0%, median PFS 10.1 months, DoR not reached. Claudin 18.2 positivity defined as >=1% tumor cells with >=1+ staining intensity. References: 10.1200/JCO.2026.44.16_suppl.4003

New BGB-B2033 in Hepatocellular carcinoma with GPC3 Protein expression: 3

Phase 1. NCT06427941. N=61 (59 efficacy-evaluable HCC). Confirmed ORR 20.3% (95% CI 11.0-32.8); at doses above predicted target efficacious dose, ORR 28.9% (11/38); 10 of 12 responders had ongoing response at data cutoff. References: 10.1200/JCO.2026.44.16_suppl.3016

New Luvometinib in Type 1 neurofibromatosis with NF1 Oncogenic mutations (germline): 3

Phase 3. NCT05913037. N=167. Luvometinib vs placebo. Confirmed ORR 43.8% vs 10.9%. Median DOR 15.1 months, 85.2% rate of DOR ≥12 months. Median TTR 3.9 months. References: 10.1200/JCO.2026.44.16_suppl.3017

New SKB500 in Small cell lung cancer, Oesophageal squamous cell carcinoma with CD276 Overexpression: 4

Phase 1 FIH study of SKB500 (B7-H3 ADC). NCT06736327. N=150. RP2D established 12 mg/kg. ORR 54.5% (30/55) DCR 92.7% (51/55) at 12mg/kg at ≥6 weeks follow-up. SCLC cohort ORR 71.4% (15/21) DCR 100%. ESCC cohort ORR 55.6% (10/18) DCR 88.9%. Response seen across B7-H3 expression level. Relationship between B7-H3 expression level and ORR not established. References: 10.1200/JCO.2026.44.16_suppl.3011

New BG-C9074 in Ovarian cancer, Breast cancer, Cholangiocarcinoma, Endometrial cancer, Lung squamous cell carcinoma with VTCN1 Protein expression: 4

Phase 1 trial. NCT06233942. N=114 efficacy-evaluable. cORR 28.1% (OC 34.5%, TNBC 31.3%, HR+/HER2- BC 17.9%). 2 CRs (1 OC, 1 TNBC). Note responses across doses and B7-H4 expression levels. References: 10.1200/JCO.2026.44.16_suppl.3013

Changed Lorlatinib in Non-small cell lung cancer with ALK EML4-ALK Fusion, Fusions: 1

Comments changed: PBS reimbursed after progression on ALK inhibitor other than Crizotinib. Phase 3 CROWN trial. NCT03052608. N=296. Lorlatinib vs crizotinib in first-line ALK-positive NSCLC. Median PFS not reached vs 9.1 months (HR 0.19). 7-year PFS 55% vs 3%. Median intracranial TTP not reached vs 16.4 months (HR 0.06). No new intracranial progression after 30 months on lorlatinib. Median DOR not reached; 53% remaining in response. In patients with baseline brain metastases, median PFS 86.3 vs 6.0 months. For patients progression-free at 24 months on lorlatinib, 79% probability of progression-free at 7 years. OS immature. Requires fluorescence in situ hybridisation (FISH) testing for ALK gene rearrangement, defined as 15% (or greater) positive cells. Last updated 2026-06-06.PBS reimbursed after progression on ALK inhibitor other than Crizotinib. Requires fluorescence in situ hybridisation (FISH) testing for ALK gene rearrangement, defined as 15% (or greater) positive cells. In Phase 3 trial vs crizotinib (CROWN): OS was superior at12 months 78% vs 39%. References changed: 30413378, 33207094, 42217582, 10.1016/j.annonc.2020.08.228230413378, 33207094, 10.1016/j.annonc.2020.08.2282. (First curated: 2020-04-16)

05 June, 2026 (Version: 20260605AU)

New Sacituzumab Govitecan + Pembrolizumab in Triple-negative breast cancer with CD274+ESR1+ERBB2 NOT ESR1:protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression and CD274:protein expression: 2

Phase 3 ASCENT-04 trial. NCT05382286. N=443. SG + pembro improved PFS vs chemo + pembro (11.2 vs 7.8 months; HR 0.65). Median PFS2 was improved in the SG + pembro group vs chemo + pembro group despite crossover therapy (not reported; HR 0.49). Median time to first subsequent therapy was 17.3 vs 9.8 months. Median time to second subsequent therapy was NR vs 21.0 months. References: 10.1200/JCO.2026.44.17_suppl.LBA1000

New Tucatinib + Trastuzumab + Pertuzumab in Breast cancer with ERBB2 Amplification, Overexpression: 2

Phase 3 HER2CLIMB-05. NCT05132582. N=654. Tucatinib+HP improved PFS over placebo+HP (HR 0.641, p<0.0001). cORR improved across all stratified subgroups (de novo/recurrent, HR status, brain metastases). References: 10.1200/JCO.2026.44.16_suppl.1005

Changed Sacituzumab Govitecan + Pembrolizumab in Triple-negative breast cancer with CD274+ESR1+ERBB2 : 2

Alterations changed: NOT ESR1:protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression and CD274:protein expressionNOT ESR1:protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression and NOT CD274:protein expression. (First curated: 2026-03-03)

03 June, 2026 (Version: 20260603AU)

New Encorafenib + Cetuximab + FOLFIRI in Colorectal adenocarcinoma with BRAF V600E: 2

Phase 3. BREAKWATER Cohort 3. NCT04607421. N=147. ORR 64.4% vs 39.2% (Odds ratio 2.76). PFS significant by BICR (key secondary endpoint met). Median treatment duration 67.9 vs 32.1 weeks. References: 10.1200/JCO.2026.44.17_suppl.LBA3503

New Trastuzumab rezetecan in Colorectal adenocarcinoma with ERBB2 Overexpression, Amplification: 2

Phase 3 trial. NCT06199973. N=130. Trastuzumab rezetecan improved PFS vs standard of care (5.5 vs 2.8 months, HR 0.33) and ORR (40.7% vs 4.5%). OS immature (HR 0.77). DoR 4.4 vs 3.4 months. References: 10.1200/JCO.2026.44.16_suppl.3505

New Tunlametinib + Vemurafenib in Colorectal adenocarcinoma with BRAF V600E: 3

Phase 3. NCT06008119. N=157. Tunlametinib+vemurafenib significantly improved PFS (4.2 vs 1.5 months; HR 0.374; P<0.001) and ORR (37.1% vs 7.7%; P<0.0001) over investigator's choice in previously treated BRAF V600E-mutant mCRC, with DCR 81.9% vs 38.5%. References: 10.1200/JCO.2026.44.17_suppl.LBA3509

New SSGJ-707 in Non-small cell lung cancer with CD274 Protein expression: 3

Phase 2. NCT06361927. N=83. SSGJ-707 monotherapy in first-line advanced NSCLC with PD-L1 TPS>=1%. FDA-aligned dose 10 mg/kg Q3W (n=34): ORR 67.6%, median DOR NR, median PFS 12.4 months, median OS NR. Subgroup analysis: SQ histology ORR 75.0%, median PFS 8.9 months; NSQ histology ORR 63.6%, median PFS 12.4 months; TPS≥50% ORR 76.9%, median PFS 12.4 months. In patients with detectable ctDNA at baseline: median PFS NR for those with nondetectable ctDNA at C3D1 versus 7.6 months for those with detectable ctDNA at C3D1. References: 10.1200/JCO.2026.44.16_suppl.8514

New SYS6043 in Ovarian cancer, Small cell lung cancer, Breast cancer, Cervical cancer, Nasopharyngeal carcinoma, Non-squamous non-small cell lung cancer, Endometrial cancer with CD276 Overexpression: 3

Phase 1/2 trial. ChiCTR2400094683. N=502. SYS6043, a novel B7-H3-targeting ADC. Primary endpoint ORR in Phase 2. Efficacy analyses focused on Q3W cohorts. SCLC (n=50) ORR 64.0%, DCR 92.0%; at 6 mg/kg Q3W ORR 75.0% including one CR. OC: ORR 46.2%, DCR 87.2%, median PFS 5.6 months at 6 mg/kg Q3W. BC: ORR 83.8%, DCR 100%. nsq-NSCLC: ORR 57.1%. CC: ORR 38.5%. NPC: ORR 37.9%. EC: ORR 30.0%. References: 10.1200/JCO.2026.44.16_suppl.3002

New BL-M14D1 in Small-cell lung cancer, Neuroendocrine carcinoma with DLL3 Protein expression: 3

Phase 1 trial. NCT06505824. N=127. BL-M14D1 in heavily pre-treated SCLC and NEC. SCLC (N=83): ORR 71.1%, cORR 57.8%, DCR 94.0%, mPFS 7.2 months. NEC (N=22): ORR 40.9%, cORR 27.3%, DCR 90.9%, mPFS 5.3 months. Doses 4.0 and 4.5 mg/kg. References: 10.1200/JCO.2026.44.16_suppl.3001

New BL-M07D1 in Ovarian cancer with ERBB2 Protein expression: 3

Phase 2 studies. NCT06031584; NCT06131450. N=65. T-Bren at 3.8mg/kg D1Q3W: cORR 88.9% platinum-sensitive OC, 47.5% platinum-resistant OC; median PFS not reached; 9-mo PFS rate 85.7% and 61.2% respectively; median prior lines 2. References: 10.1200/JCO.2026.44.16_suppl.3003

New Ori-C101 in Hepatocellular carcinoma with GPC3 Protein expression: 3

Phase 1b BEACON study. NCT05652920. N=19. GPC3-directed CAR-T Ori-C101 in heavily pretreated advanced HCC. Confirmed ORR 50.0% (9/18), DCR 77.8% (14/18). At RP2D (Dose Level 3), confirmed ORR was 66.7% (6/9), DCR was 88.9% (8/9). Median OS was 14.4 months. References: 10.1200/JCO.2026.44.16_suppl.2508

New GFH375 in Cholangiocarcinoma with KRAS G12D: 3

Phase 1/2 NCT06500676. N=20 cholangiocarcinoma (CCA) and 41 colorectal cancer (CRC). CCA: ORR 35.0% (7/20), DCR 95.0%, median PFS 6.3 months. CRC: ORR 11.4% (4/35), DCR 77.1%, median PFS 4.1 months. References: 10.1200/JCO.2026.44.16_suppl.3008

New RNK08954 in Non-small cell lung cancer with KRAS G12D: 3

Phase 1 NCT06667544. N=47 NSCLC KRAS G12D. ORR 38.5% (15/39). DCR 94.9%. Median DoR not reached. Median PFS pending. References: 10.1200/JCO.2026.44.16_suppl.3006

New TSN1611 in Non-small cell lung cancer with KRAS G12D: 3

Phase 1/2. NCT06385925. N=117 total (26 NSCLC). In evaluable NSCLC patients at 600-1200 mg BID: ORR 50% (10 PR, 8 SD), DCR 90%. Median PFS not mature, 9-month PFS rate 54.5%. Intracranial responses observed. References: 10.1200/JCO.2026.44.16_suppl.8516

New DN022150 in Solid tumors, Pancreatic cancer with KRAS G12D: 3

Phase 1/2a. CTR20242749. N=31 evaluable. DN022150 in KRAS G12D advanced solid tumors. ORR 37.5% at 450mg, 31.3% at 650mg. DCR 87.5% and 93.8% respectively. 96.8% target lesion reduction. References: 10.1200/JCO.2026.44.16_suppl.3007

New Onvansertib + FOLFIRI + Bevacizumab in Colorectal adenocarcinoma with KRAS Oncogenic mutations: 3

Phase 2 CRDF-004 trial. NCT06106308. N=110. Onvansertib plus FOLFIRI and bevacizumab in first-line RAS-mutated mCRC: ORR 72.2% vs 43.2% SoC (p=0.051); 6-month ORR 55.6% vs 21.1% FOLFIRI+Bev (p=0.045); median PFS not reached vs 10.97 months SoC; PFS HR 0.37 vs SoC (p=0.048); 12-month PFS rate 61.9% vs 30.1%. References: 10.1200/JCO.2026.44.16_suppl.3510

New Onvansertib + FOLFIRI + Bevacizumab in Colorectal adenocarcinoma with NRAS Oncogenic mutations: 3

Phase 2 CRDF-004 trial. NCT06106308. N=110. Onvansertib plus FOLFIRI and bevacizumab in first-line RAS-mutated mCRC: ORR 72.2% vs 43.2% SoC (p=0.051); 6-month ORR 55.6% vs 21.1% FOLFIRI+Bev (p=0.045); median PFS not reached vs 10.97 months SoC; PFS HR 0.37 vs SoC (p=0.048); 12-month PFS rate 61.9% vs 30.1%. References: 10.1200/JCO.2026.44.16_suppl.3510

New NT-175 in Colorectal adenocarcinoma, Pancreatic adenocarcinoma, Breast cancer, Solid tumours with TP53 R175H: 3

Phase 1. NCT05877599. N=21 infused. NT-175 in TP53 R175H-mutated advanced solid tumors. ORR 47.6% overall, 53.8% in DL3. PR in 10 pts (5/6 PDAC, 2/10 CRC, 2/2 BC, 1 other). DCR 66.7%. 5 of 7 evaluable PR pts with ≥6 months follow-up remain in PR. References: 10.1200/JCO.2026.44.16_suppl.2506

New GFH375 in Colorectal cancer with KRAS G12D: 4

Phase 1/2 NCT06500676. N=20 cholangiocarcinoma (CCA) and 41 colorectal cancer (CRC). CCA: ORR 35.0% (7/20), DCR 95.0%, median PFS 6.3 months. CRC: ORR 11.4% (4/35), DCR 77.1%, median PFS 4.1 months. References: 10.1200/JCO.2026.44.16_suppl.3008

New Tremelimumab + Durvalumab + Pemetrexed + Carboplatin in Non-small cell lung cancer with KRAS Oncogenic mutations: 4

Phase 2b TRITON. NCT06008093. N=84 (41 vs 43). ORR 39.0% vs 34.9% for T+D+CT vs P+CT. Median DoR NR vs 6.4 months. 6-month response rate 100% vs 58.3%. In KRAS mut-only ORR 48.0% vs 33.3%. Interim analysis. Primary endpoint PFS not yet reported. References: 10.1200/JCO.2026.44.16_suppl.8515

New Encorafenib + Cetuximab + Nivolumab, Nivolumab in Colorectal adenocarcinoma with BRAF+Microsatellite Instability BRAF:V600E and NOT Microsatellite instability:high: R2

Phase 2 trial. SWOG S2107. NCT05308446. N=85. Randomized 2:1. In previously treated MSS BRAFV600E mCRC, adding nivolumab to encorafenib + cetuximab did not improve PFS (5.8 vs 6.3 months, HR 1.10) or OS (13.5 vs 11.6 months, HR 0.85). ORR 35% vs 32%. Primary endpoint not met. Ongoing correlative studies for biomarkers. References: 10.1200/JCO.2026.44.16_suppl.3504

01 June, 2026 (Version: 20260601AU)

New Daraxonrasib in Pancreatic ductal adenocarcinoma with KRAS G12, G12D, G12V, G13, Q61, Oncogenic mutations: 2

Phase 3 RASolute 302 trial. NCT06625320. N=500. Daraxonrasib improved OS vs chemotherapy in RAS G12 population (13.2 vs 6.6 months; HR 0.40) and overall population (13.2 vs 6.7 months; HR 0.40). PFS improved in RAS G12 population (7.3 vs 3.5 months; HR 0.45) and overall population (7.2 vs 3.6 months; HR 0.49). References: 10.1200/JCO.2026.44.17_suppl.LBA5, 10.1056/NEJMoa2605555

New Daraxonrasib in Pancreatic adenocarcinoma with KRAS G12, G12D, G12V, G12R, G12A, G12L, G12S, G13, Q61, Oncogenic mutations: 3

Phase 1-2. NCT05379985. Daraxonrasib in previously treated RAS-mutated PDAC. In RAS G12 mutations (second-line, 300 mg, n=26): ORR 35% (95% CI 17-56), median DOR 8.2 months, median PFS 8.5 months, median OS 13.1 months. In RAS G12/G13/Q61 mutations (n=38): ORR 29% (95% CI 15-46), median DOR 8.2 months, median PFS 8.1 months, median OS 15.6 months. References: 42090791

New Rogaratinib in Gastrointestinal stromal tumour with SDHA Loss of protein expression, Oncogenic mutations, Loss-of-function mutations: 3

Phase 2 trial. NCT04595747. N=24. Rogaratinib achieved ORR of 41.7% (10 PR). Median PFS was 31.0 months. 1-year PFS was 77.4%. Objective responses seen across all SDH molecular subsets. References: 42191879

New Rogaratinib in Gastrointestinal stromal tumour with SDHB Loss of protein expression, Oncogenic mutations, Loss-of-function mutations: 3

Phase 2 trial. NCT04595747. N=24. Rogaratinib achieved ORR of 41.7% (10 PR). Median PFS was 31.0 months. 1-year PFS was 77.4%. Objective responses seen across all SDH molecular subsets. References: 42191879

New Rogaratinib in Gastrointestinal stromal tumour with SDHC Loss of protein expression, Oncogenic mutations, Loss-of-function mutations, Promoter hypermethylation: 3

Phase 2 trial. NCT04595747. N=24. Rogaratinib achieved ORR of 41.7% (10 PR). Median PFS was 31.0 months. 1-year PFS was 77.4%. Objective responses seen across all SDH molecular subsets. References: 42191879

31 May, 2026 (Version: 20260531AU)

New Silevertinib in Non-small cell lung cancer with EGFR Oncogenic mutations AND NOT L858R AND NOT Exon 19 deletion, P-loop mutations, Alpha-c-helix mutations: 3

Phase 2. NCT05256290. N=43. Treatment-naive nonclassical EGFR mutant NSCLC. ORR 60% (ITT), PACC 56%, compound 69%. DCR 91%. CNS ORR 86%. 6-month PFS rate 86% overall, 80% in CNS metastasis patients. ctDNA clearance 81%. References: 10.1200/JCO.2026.44.16_suppl.8519

New DZD6008 in Non-small cell lung cancer with EGFR C797S: 3

Phase 1/2 TIAN-SHAN1 and TIAN-SHAN2. NCT06905197, NCT06813365. N=24. DZD6008 in pretreated EGFR C797X+ NSCLC. ORR 41.7% overall, 23.1% at 40 mg, 60.0% at 60 mg. Median DoR and PFS not reached. 9-month PFS rates 54.5% and 64.8% at recommended phase 2 doses. References: 10.1200/JCO.2026.44.16_suppl.8520

New TSN1611 in Non-small cell lung cancer with KRAS G12D: 3

Phase 1/2. NCT06385925. N=117 total (26 NSCLC). In evaluable NSCLC patients at 600-1200 mg BID: ORR 50% (10 PR) with DCR 90%. Median PFS not mature, 9-month PFS rate 54.5%. Intracranial responses seen. References: 10.1200/JCO.2026.44.16_suppl.8516

30 May, 2026 (Version: 20260530AU)

New Sunvozertinib in Non-small cell lung cancer with EGFR Exon 20 insertion, A767_S768insASV (A767_V769dupASV), D770_N771insSVD (S768_D770dupSVD), A763_Y764insFQEA, A763_Y764insLQEA, S768_V769insTLA, V769_D770insGLV, V769_D770insGSV, V769_D770insGVQ, V769_D770insSSV, D770_N771insESH, D770_N771insG, D770_N771insGF, D770_N771insGL, D770_N771insSTD, D770_N771insTAW, D770_N771insCGN, D770_N771insGY, N771_P772insG, N771_P772insH, N771_P772insHN, N771_P772insN, N771_P772insT, N771_P772insV, N771_P772insFH, N771_P772insGF, N771_P772insGT, N771_P772insGY, N771_P772insTH, P772_H773insDNP, P772_H773insGHP, P772_H773insLNP, P772_H773insPHP, P772_H773insPNP, P772_H773insQ, P772_H773insRNP, P772_H773insTNP, P772_H773insTQPNP, P772_H773insYNP, H773_V774insLM, H773_V774insAH, H773_V774insGHPH, H773_V774insGNPH, H773_V774insH, H773_V774insNPH, H773_V774insPH, H773_V774insPHPH, H773_V774insTH, H773_V774insY, H773_V774insNPNPY, H773_V774insNPY, H773_V774insPNPY, H773_V774insYNPY, V774_C775insHV, C775_S776insPHVC: 2

Phase 3. WU-KONG28. NCT05668988. N=324. Sunvozertinib demonstrated significantly longer median PFS versus carboplatin + pemetrexed (10.3 vs 7.5 months; HR 0.65) in first-line advanced nonsquamous NSCLC with EGFR exon 20 insertions. 12-month PFS rates were 46.1% versus 26.7%. ORR was 58.9% versus 31.1%. Median duration of response 11.2 versus 7.1 months. Median best percentage change in tumor size 42.1% versus 24.7%. OS data immature. References: 42212913, 10.1200/JCO.2026.44.17_suppl.LBA8500

Changed Asciminib in Chronic myelogenous leukaemia with ABL1 BCR-ABL1 Fusion, T315I, E255K, E255V, Y253H, F359V, Q252H, G250H, E459K: 3

Comments changed: Phase 1 NCT02081378. Asciminib in chronic-phase CML after TKI failure. N=150 heavily pretreated (70% ≥3 TKIs). Among those with hematologic relapse, 92% achieved complete hematologic response; 54% without CCyR at baseline achieved CCyR. Major molecular response (MMR) achieved or maintained by 12 months in 48% of evaluable patients, including 57% with ponatinib resistance/intolerance and 28% with T315I mutation at baseline. MMR maintained in 40 of 44 patients.. (First curated: 2020-05-21)

25 May, 2026 (Version: 20260525AU)

New Enasidenib + Cisplatin + Gemcitabine + Durvalumab in Cholangiocarcinoma with IDH2 R172, R172W, R172K, R172M: 4

Case series. Retrospective analysis. N=6. IDH2-mutated intrahepatic cholangiocarcinoma. One patient treated with enasidenib plus chemoimmunotherapy with time on treatment 18.1 months. References: 10.1016/j.annonc.2025.05.365

New Enasidenib in Cholangiocarcinoma with IDH2 R172: 4

Multi-institutional retrospective study. IDH2-mutated cholangiocarcinoma. N=40. Off-label enasidenib subsequent line (N=8) median PFS 3.9 months (1.1-5.1). Survival similar to IDH1 mutated, further investigation warranted. References: 10.1200/JCO.2026.44.2_suppl.567

New LY3410738, LY3410738 + Cisplatin + Gemcitabine, LY3410738 + Durvalumab in Cholangiocarcinoma, Glioma with IDH1 R132C, R132G, R132L, R132S: 4

Phase 1. NCT04521686. N=119. LY3410738 monotherapy ORR 5.2% in relapsed/refractory cholangiocarcinoma and 11.1% in glioma with DCR 56.9% and 63.0% respectively. LY3410738 plus CISGEM in newly diagnosed cholangiocarcinoma showed ORR 42.1%, median DOR 8.1 months, median PFS 10.2 months. Responses were seen in IDH1 (2/30) mutant treated with monotherapy. References: 41026608

New LY3410738, LY3410738 + Cisplatin + Gemcitabine, LY3410738 + Durvalumab in Cholangiocarcinoma, Glioma with IDH2 R172G, R172K, R172M, R172W: 4

Phase 1. NCT04521686. N=119. LY3410738 monotherapy ORR 5.2% in relapsed/refractory cholangiocarcinoma and 11.1% in glioma with DCR 56.9% and 63.0% respectively. LY3410738 plus CISGEM in newly diagnosed cholangiocarcinoma showed ORR 42.1%, median DOR 8.1 months, median PFS 10.2 months. Responses were seen in IDH2 (1/16) mutant treated with monotherapy. References: 41026608

New Venetoclax + Decitabine in Cholangiocarcinoma with IDH2 R172W: 4

Case report. Metastatic refractory IDH2 R172W-mutant cholangiocarcinoma. Venetoclax plus decitabine resulted in ongoing near-complete response for 15 months. Regression in multiple lesions observed. First report demonstrating benefit from V + D in solid tumor. References: 39913887

New Ivosidenib in Cholangiocarcinoma with IDH2 R172K: R2

Case series and preclinical study. NCT02073994. Two IDH1-mutated cholangiocarcinoma patients treated with ivosidenib achieved 17 and 23.5 months stable disease before progression via acquired IDH2 or IDH1 D279N mutation. In vitro IDH1 R132H/D279N cells resistant to ivosidenib but sensitive to LY3410738 which blocked (R)-2HG production and cellular transformation. References: 36056177

New Ivosidenib in Cholangiocarcinoma with IDH1 D279N: R2

Case series and preclinical study. NCT02073994. Two IDH1-mutated cholangiocarcinoma patients treated with ivosidenib achieved 17 and 23.5 months stable disease before progression via acquired IDH2 or IDH1 D279N mutation. In vitro IDH1 R132H/D279N cells resistant to ivosidenib but sensitive to LY3410738 which blocked (R)-2HG production and cellular transformation. References: 36056177

New LY3410738 in Cholangiocarcinoma with IDH1 R132C and D279N: 4

Case series and preclinical study. NCT02073994. Two IDH1-mutated cholangiocarcinoma patients treated with ivosidenib achieved 17 and 23.5 months stable disease before progression via acquired IDH2 or IDH1 D279N mutation. In vitro IDH1 R132H/D279N cells resistant to ivosidenib but sensitive to LY3410738 which blocked (R)-2HG production and cellular transformation. References: 36056177

Changed Pembrolizumab in Head and neck squamous cell carcinoma with CD274 Protein expression: 1

Comments changed: TGA approved. Not PBS reimbursed. Approved for CPS >= 1; PBS-subsidised if the PD-L1 CPS >= 20 in the tumour sample.. (First curated: 2020-04-16)

Changed Atezolizumab in Non-small cell lung cancer with CD274+EGFR+ALK CD274:Protein expression and NOT EGFR:Oncogenic mutations and NOT ALK:fusion: 1

Comments changed: TGA approved. PBS reimbused. Phase 3 IMpower110 trial (NCT02409342, N=572) evaluated first-line atezolizumab in EGFR and ALK negative NSCLC patients with PD-L1 expression ≥1% on tumor cells or tumor-infiltrating immune cells covering ≥1% of tumor area. Atezolizumab significantly improved median OS compared to chemotherapy (20.2 vs 13.1 months, improvement of 7.1 months).. (First curated: 2020-12-11)

Changed Amivantamab in Non-small cell lung cancer with EGFR Exon 20 insertion: 1

Comments changed: TGA approved. Not PBS Listed. FDA accelerated approval 2021-05-21. Median PFS 8.3 months. "Phase 1 CHRYSALIS trial. N=81. Amivantamab, an EGFR-MET bispecific antibody, showed an ORR of 40% (3 complete responses) and median DOR of 11.1 months in patients with EGFR Exon20ins NSCLC progressing on platinum chemotherapy, with a median PFS of 8.3 months.. (First curated: 2021-05-22)

Changed Amivantamab + Carboplatin + Pemetrexed in Non-small cell lung cancer with EGFR Exon 20 insertion: 1

Comments changed: PBS listed. Phase 3 trial. PAPILLON. NCT04538664. N=308. Amivantamab-chemotherapy (carboplatin-pemetrexed) was associated with superior progression-free survival (11.4 months versus 6.7 months) and a higher overall response rate (73% vs 47%) compared to chemotherapy alone in patients with advanced NSCLC with EGFR exon 20 insertions as first line treatment.TGA approved. Not PBS Listed. Not FDA approved. Phase 3 trial. PAPILLON. NCT04538664. N=308. Amivantamab-chemotherapy (carboplatin-pemetrexed) was associated with superior progression-free survival (11.4 months versus 6.7 months) and a higher overall response rate (73% vs 47%) compared to chemotherapy alone in patients with advanced NSCLC with EGFR exon 20 insertions as first line treatment.. (First curated: 2023-10-29)

Changed Sacituzumab Govitecan in Triple-negative breast cancer with ESR1+ERBB2 NOT ESR1:protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression: 1

Comments changed: TGA approved; Not PBS reimbursed. FDA approved. Phase 3 ASCENT trial (NCT02574455, N=468): Sacituzumab govitecan significantly improved PFS (5.6 vs 1.7 months) and OS (12.1 vs 6.7 months) over single-agent chemotherapy in metastatic triple-negative breast cancer, with an ORR of 35%.. (First curated: 2020-05-01)

Changed Selpercatinib in Non-small cell lung cancer with RET Fusion, KIF5B-RET fusion, CCDC6-RET fusion, NCOA4-RET fusion, KIF13A-RET fusion, KIAA1549L-RET fusion, KIAA1468-RET fusion, PRKAR1A-RET fusion: 1

Comments changed: TGA approved. Not PBS reimbursed. Phase 3 trial. LIBRETTO-431. NCT04194944. N=261. Selpercatinib (1st line) improved PFS over chemoimmunotherapy (24.8 vs 11.2 months). ORR was similar between the two arms at 84% and 65%. The cause-specific hazard ratio for the time to CNS progression was 0.28.. (First curated: 2023-10-29)

Changed Bosutinib in Chronic myelogenous leukaemia with ABL1 BCR-ABL1 Fusion: 1B

Comments changed: TGA approved. Not PBS reimbursed. Third or later line treatment. BFORE trial.. (First curated: 2020-05-21)

21 May, 2026 (Version: 20260521AU)

New Temsirolimus in Endometrial cancer, Solid tumours except Breast Cancer, Colorectal cancer with PIK3CA Oncogenic mutations, H1047R: 3

Phase 2. TAPUR basket trial. N=83. Temsirolimus in PIK3CA-mutated solid tumors. Primary endpoint disease control (DC) defined as OR or SD ≥16 weeks. BC cohort DC rate 9%, Median PFS 8 weeks, Median OS 36 weeks. CRC cohort DC rate 9%, Median PFS 8 weeks, Median OS 37 weeks. UC cohort DC rate 37%, Median PFS 16 weeks, Median OS 37 weeks, Median DOSD 31 weeks. HP cohort DC rate 31%, Median PFS 9 weeks, Median OS 27 weeks, Median DOSD 28 weeks. Overall OR rate 8%. Null hypothesis of 15% DC rate rejected for UC and HP cohorts. H1047R mutation subgroup OR rate 18%. DOR for PR in UC up to 84 weeks. DOR for PR in HP up to 229 weeks ongoing. Antitumor activity demonstrated in UC and HP cohorts but not BC or CRC. References: 42018965

New Temsirolimus in Breast cancer, Colorectal cancer with PIK3CA Oncogenic mutations: R2

Phase 2. TAPUR basket trial. N=83. Temsirolimus in PIK3CA-mutated solid tumors. Primary endpoint disease control (DC) defined as OR or SD ≥16 weeks. BC cohort DC rate 9%, Median PFS 8 weeks, Median OS 36 weeks. CRC cohort DC rate 9%, Median PFS 8 weeks, Median OS 37 weeks. UC cohort DC rate 37%, Median PFS 16 weeks, Median OS 37 weeks, Median DOSD 31 weeks. HP cohort DC rate 31%, Median PFS 9 weeks, Median OS 27 weeks, Median DOSD 28 weeks. Overall OR rate 8%. Null hypothesis of 15% DC rate rejected for UC and HP cohorts. H1047R mutation subgroup OR rate 18%. DOR for PR in UC up to 84 weeks. DOR for PR in HP up to 229 weeks ongoing. Antitumor activity demonstrated in UC and HP cohorts but not BC or CRC. References: 42018965

18 May, 2026 (Version: 20260518AU)

New Osimertinib in Colorectal adenocarcinoma with EGFR T790M: 4

Case report and preclinical study. Single patient with EGFR T790M mutated colorectal cancer. Patient-derived xenograft and cell line models generated from colon specimen. In vitro IC50 values showed sensitivity to irinotecan and osimertinib versus resistance to oxaliplatin, erlotinib, and cetuximab, validated PDX model validated irinotecan and fluorouracil sensitivity and oxaliplatin resistance. Sensitivity to osimertinib maintained despite BRAF V600E mutation. References: 35135168

New Osimertinib in Colorectal adenocarcinoma with EGFR T790M: 4

Case report. Metastatic colorectal cancer. EGFR T790M mutation detected on cell-free DNA. RAS/RAF wild-type. Fourth-line off-label osimertinib. Clinical response with decrease in hepatic metastases size. Variant allele frequency reduced from 13.3% to 2.1%. DOR 7 months. References: 37969405

New Erlotinib in Colorectal adenocarcinoma with EGFR T790M: R2

Case report and preclinical study. Single patient with EGFR T790M mutated colorectal cancer. Patient-derived xenograft and cell line models generated from colon specimen. In vitro IC50 values showed sensitivity to irinotecan and osimertinib versus resistance to oxaliplatin, erlotinib, and cetuximab, validated PDX model validated irinotecan and fluorouracil sensitivity and oxaliplatin resistance. Sensitivity to osimertinib maintained despite BRAF V600E mutation. References: 35135168

New Precemtabart tocentecan in Colorectal cancer with CEACAM5 Protein expression: 4

Phase 1. PROCEADE-CRC-01. NCT05464030. N=40. Heavily pretreated irinotecan-refractory metastatic colorectal cancer. Precemtabart tocentecan. Confirmed ORR 7.5% (3/40), unconfirmed 15.0% (6/40), all at dose levels ≥2.4 mg/kg. Median PFS 5.9 months (95% CI: 4.6–7.2); at dose levels ≥2.4 mg/kg (n=34), median PFS 6.7 months (95% CI: 4.6–8.8). References: 40739424

Changed Durvalumab + Savolitinib in Papillary renal cell carcinoma with HGF Amplification: 3

Comments changed: Phase 2. CALYPSO. N=41. Savolitinib plus durvalumab in metastatic papillary renal cancer. ORR 34% in ITT population versus 53% in MET-driven patients (n=17). Median PFS 6.5 months versus 13.9 months and OS 18.3 months versus 27.4 months i n ITT and MET-driven populations respectively. ctDNA clearance correlated with improved OS (31.3 v 7.2 months). Updated 2026-05-18Phase 2 CALYPSO: MET-driven PRCC. ORR 57% (8/14). References changed: 41861260, 10.1200/JCO.2021.39.15_suppl.4511. (First curated: 2021-06-15)

Changed Durvalumab + Savolitinib in Papillary renal cell carcinoma with MET Alteration, Amplification, Oncogenic mutations: 3

Comments changed: Phase 2. CALYPSO. N=41. Savolitinib plus durvalumab in metastatic papillary renal cancer. ORR 34% in ITT population versus 53% in MET-driven patients (n=17). Median PFS 6.5 months versus 13.9 months and OS 18.3 months versus 27.4 months i n ITT and MET-driven populations respectively. ctDNA clearance correlated with improved OS (31.3 v 7.2 months). Updated 2026-05-18Phase 2 CALYPSO: MET-driven PRCC. ORR 57% (8/14). References changed: 41861260, 10.1200/JCO.2021.39.15_suppl.4511. (First curated: 2021-06-15)

17 May, 2026 (Version: 20260517AU)

New Neladalkib in Solid tumours with ALK Fusion: 3

Phase 1/2 ALKOVE-1. NCT05384626. N=21. Neladalkib in ALK+ solid tumors other than NSCLC. ORR 48% (10/21) across 11 tumor types. DOR range 1.3+ - 8.6+ months (9/10 ongoing). ALK TKI-naive ORR 83% (5/6) all ongoing. CNS activity included complete resolution of CNS mets in alectinib- and lorlatinib-pretreated pts. References: 10.1016/j.annonc.2025.08.1541

New Alectinib in Solid tumours, Non-small cell lung cancer, Pancreatic adenocarcinoma, Neuroendocrine carcinoma, Neuroendocrine tumour, Sarcoma with ALK Fusion, EML4-ALK fusion, TNS1-ALK fusion, TPR-ALK fusion, KIF5B-ALK fusion, CAD-ALK fusion: 3

Phase 2. MoST substudy 14. ACTRN12621000312842. N=16. Alectinib in ALK-altered solid tumours and NSCLC with negative standard care testing. ORR 50% (n=8, 95% CI 28-72%) plus one unconfirmed PR. Median PFS 16.0 months (95% CI 5.7-17.5); median OS not reached. 6-month PFS rate 73%. 1L NSCLC discordant testing: 3 of 4 responded (1 CR, 2 PR). Solid tumours (n=12): 5 responses across diverse histologies. No response in nasopharyngeal carcinoma with R1275Q/HRAS G13R. References: 10.1016/j.annonc.2025.08.1565

New FOG-001 in Solid tumors, Desmoid tumors, Ameloblastoma, Adamantinomatous craniopharyngioma, Salivary gland carcinoma with CTNNB1 Oncogenic mutation: 4

Phase 1/2. NCT05919264. N=83. FOG-001 monotherapy in patients with solid tumors bearing Wnt pathway-activating mutations (WPAM+). In Wnt-β-catenin driven solid tumors (N=14), ORR was 43% and DCR 79%. In desmoid tumors (N=5), ORR and DCR were 60% and 100%, respectively. In MSS CRC, DCR was 50% at higher dose levels (240–480 mg/m2) with molecular responses (≥50% ctDNA reduction) in 60% of pts. References: 10.1158/1535-7163.TARG-25-B031

Changed Tepotinib in Non-small cell lung cancer with MET Exon 14 Deletion, Exon 14 splicing mutation, Exon 14 skipping mutation: 1

Tier changed: 1B. Comments changed: TGA approved. PBS listed. FDA approved. VISION trial. NCT02864992. N=152. Detection of MET exon14 skipping mutation was performed on either liquid biopsy or biospy of the archival tumour tissue. Across all lines of therapy in the efficacy population (N=99), ORR was 48% in the liquid-biopsy group and 50% in the tissue-biopsy group. Molecular cfDNA response to tepotinib was defined as complete response at least 75% of depletion of cfDNA.TGA approved. FDA approved. VISION trial. NCT02864992. N=152. Detection of MET exon14 skipping mutation was performed on either liquid biopsy or biospy of the archival tumour tissue. Across all lines of therapy in the efficacy population (N=99), ORR was 48% in the liquid-biopsy group and 50% in the tissue-biopsy group. Molecular cfDNA response to tepotinib was defined as complete response at least 75% of depletion of cfDNA.. (First curated: 2020-05-20)

13 May, 2026 (Version: 20260513AU)

Changed Abemaciclib + Letrozole, Abemaciclib + Anastrazole in Breast cancerESR1:Protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression: 1

Biomarker changed: ESR1+ERBB2ERBB2+ESR1. (First curated: 2020-04-16)

Changed Palbociclib + Letrozole in Breast cancerESR1:Protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression: 1

Biomarker changed: ESR1+ERBB2ERBB2+ESR1. (First curated: 2020-04-16)

Changed Ribociclib + Letrozole in Breast cancerESR1:Protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression: 1

Biomarker changed: ESR1+ERBB2ERBB2+ESR1. (First curated: 2020-04-16)

Changed Elacestrant in Breast cancerESR1:Protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression: 2

Biomarker changed: ESR1+ERBB2ERBB2+ESR1. (First curated: 2022-05-24)

Changed Giredestrant + Everolimus in Breast cancerESR1:Protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression: 2

Biomarker changed: ESR1+ERBB2ERBB2+ESR1. (First curated: 2025-10-19)

Changed Camizestrant + Palbociclib, Camizestrant + Ribociclib, Camizestrant + Abemaciclib in Breast cancerESR1:Protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression and ESR1:Oncogenic mutations, ESR1:D538G, ESR1:Y537S, ESR1:Y537N: 2

Biomarker changed: ESR1+ERBB2ERBB2+ESR1. (First curated: 2026-03-03)

Changed Vepdegestrant in Breast cancerESR1:Protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression; ESR1:Protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression and ESR1:Oncogenic mutations: 2

Biomarker changed: ESR1+ERBB2ERBB2+ESR1. (First curated: 2026-03-03)

Changed Gedatolisib + Fulvestrant + Palbociclib, Gedatolisib + Fulvestrant, in Breast cancerPIK3CA:oncogenic mutations + ESR1:Protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression: 2

Biomarker changed: ESR1+ERBB2+PIK3CAERBB2+ESR1+PIK3CA. (First curated: 2025-10-19)

Changed Zanidatamab + Palbociclib + Fulvestrant in Breast cancerESR1:Protein expression AND ERBB2:Amplification, ESR1:Protein expression AND ERBB2:Overexpression: 3

Biomarker changed: ESR1+ERBB2ERBB2+ESR1. (First curated: 2026-03-03)

Changed Gedatolisib + Palbociclib + Letrozole, Gedatolisib + Palbociclib + Fulvestrant in Breast cancerESR1:Protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression: 3

Biomarker changed: ESR1+ERBB2ERBB2+ESR1. (First curated: 2025-07-30)

Changed PF-07104091 in Breast cancerESR1:Protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression: 3

Biomarker changed: ESR1+ERBB2ERBB2+ESR1. (First curated: 2024-01-31)

Changed PF-07220060 in Breast cancerESR1:Protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression: 3

Biomarker changed: ESR1+ERBB2ERBB2+ESR1. (First curated: 2024-01-31)

Changed PF-07248144 in Breast cancerESR1:Protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression: 4

Biomarker changed: ESR1+ERBB2ERBB2+ESR1. (First curated: 2024-06-09)

Changed Therapy in Breast cancer with FGFR1 Amplification: R2

Therapy changed: Fulvestrant + Palbociclib, Fulvestrant + Ribociclib, Fulvestrant + Abemaciclib, Letrozole + Palbociclib, Letrozole + Ribociclib, Letrozole + Abemaciclib, Fulvestrant, Letrozole, Anastrozole, Exemestane, Tamoxifen, Goserelin, Medroxyprogesterone Acetate. (First curated: 2020-04-15)

11 May, 2026 (Version: 20260511AU)

New Palbociclib + Avelumab in Solid tumours with CDK4 Amplification: R2

Phase 2. ACTRN12620000568910. N=64. Palbociclib priming followed by avelumab in advanced solid tumours with CDK4/6 pathway alterations, including sarcomas and pancreatic cancer yielded no confirmed objective responses. PFS6 was 40% in the gain-of-function cohort and 16% in the loss-of-function cohort. Median OS was 12.7 months (gain-of-function) and 5.6 months (loss-of-function). Updated 2026-05-11. References: 10.1016/j.annonc.2025.08.2175

New Palbociclib + Avelumab in Solid tumours with CDKN2A Oncogenic mutations, Deletions, Truncating mutations, Loss-of-function mutations: R2

Phase 2. ACTRN12620000568910. N=64. Palbociclib priming followed by avelumab in advanced solid tumours with CDK4/6 pathway alterations, including sarcomas and pancreatic cancer yielded no confirmed objective responses. PFS6 was 40% in the gain-of-function cohort and 16% in the loss-of-function cohort. Median OS was 12.7 months (gain-of-function) and 5.6 months (loss-of-function). Updated 2026-05-11. References: 10.1016/j.annonc.2025.08.2175

New VT3989 in Mesothelioma, Solid tumours with NF2 Oncogenic mutations: 4

Phase 1/2. NCT04665206. N=172 (135 mesothelioma). VT3989 ORR 26% in 47 mesothelioma patients at clinically optimized doses. ORR 32% (DCR 86%; median PFS 10 months) in 22 mesothelioma patients with optimized doses and UACR thresholds. References: 41111090

New RMC-6236 in Non-small cell lung cancer with RRAS Q87L: 4

Preclinical and retrospective study. N=8,488 NSCLC sequenced. RRASQ87L or RRAS2Q72L mutations identified in 0.45% (38/8,488). RMC-6236 suppressed proliferation in vitro. In vivo, RMC-6236 significantly inhibited growth of RRASQ87L/RRAS2Q72L-mutant HBEC-derived xenografts. Supports inclusion of RRAS/RRAS2 in diagnostic panels and clinical investigation of pan-RAS inhibitors. References: 41543339

New RMC-6236 in Non-small cell lung cancer with RRAS2 Q72L: 4

Preclinical and retrospective study. N=8,488 NSCLC sequenced. RRASQ87L or RRAS2Q72L mutations identified in 0.45% (38/8,488). RMC-6236 suppressed proliferation in vitro. In vivo, RMC-6236 significantly inhibited growth of RRASQ87L/RRAS2Q72L-mutant HBEC-derived xenografts. Supports inclusion of RRAS/RRAS2 in diagnostic panels and clinical investigation of pan-RAS inhibitors. References: 41543339

New Cetuximab in Colorectal adenocarcinoma with KRAS+NRAS+BRAF+EGFR+PIK3CA+MAP2K1+AKT1+MET+PTEN+ERBB2 NOT KRAS:Oncogenic mutation and NOT NRAS:Oncogenic mutation and NOT BRAF:Oncogenic mutation and NOT EGFR:Oncogenic mutation and NOT PIK3CA:Exon 20 mutation and NOT MAP2K1:Oncogenic mutation and NOT AKT1:Oncogenic mutation and NOT MET:Oncogenic mutation and NOT PTEN:Oncogenic mutation and NOT ERBB2:amplification: 4

Phase 2. CAVE-2 GOIM. NCT05291156. N=156. Cetuximab plus avelumab did not improve OS over cetuximab monotherapy (14.8 vs 12.9 months) or PFS (5.3 vs 4.3 months) in RAS/BRAF WT refractory mCRC. In negative hyperselection subgroup (no resistance PVs), mPFS was significantly prolonged (5.35 vs 3.65 months) and mOS improved (15.0 vs 11.1 months) compared to positive hyperselection. ORR 12% vs 3% in negative vs positive hyperselection. References: 41443411

New Cetuximab, Panitumumab in Colorectal adenocarcinoma with KRAS Oncogenic mutations, Amplification: R2

Translational study. N=10 progression biopsies. Acquired KRAS mutations in 60% (6/10) and amplification in 1/10 of colorectal cancer cases resistant to anti-EGFR therapy. KRAS mutant alleles detectable in plasma 10 months prior to radiographic progression. In vitro resistant cell lines (DiFi-R, Lim1215-R) regained sensitivity with combinatorial EGFR and MEK inhibition. Ectopic KRAS expression conferred cetuximab resistance in parental lines. Suggests blood-based monitoring and early MEK inhibitor initiation. References: 22722830

New LY3410738 in Cholangiocarcinoma, Glioma with IDH1 R132: 4

Phase I. NCT04521686. N=119. LY3410738 dual IDH1/2 inhibitor in IDH-mutant solid tumors. Monotherapy relapsed/refractory cholangiocarcinoma ORR 5.2% (N=58), median PFS 3.5 months, median OS 13.9 months. Monotherapy glioma ORR 11.1% (N=27), median PFS 7.9 months. Responses were seen in both IDH1 and IDH2 groups across dose levels. References: 41026608

New LY3410738 in Cholangiocarcinoma, Glioma with IDH2 R172, R140: 4

Phase I. NCT04521686. N=119. LY3410738 dual IDH1/2 inhibitor in IDH-mutant solid tumors. Monotherapy relapsed/refractory cholangiocarcinoma ORR 5.2% (N=58), median PFS 3.5 months, median OS 13.9 months. Monotherapy glioma ORR 11.1% (N=27), median PFS 7.9 months. Responses were seen in both IDH1 and IDH2 groups across dose levels. References: 41026608

New TNG908, TNG908 + AG-270, TNG908 + Abemaciclib, TNG908 + Palbociclib in Solid tumours, Glioblastoma, Non-small cell lung cancer, Mesothelioma, Pancreatic adenocarcinoma, Cholangiocarcinoma, Bladder cancer with MTAP Deletion: 4

Phase I/II trial. NCT05275478. TNG908 is a brain-penetrant, MTA-cooperative PRMT5 inhibitor for MTAP-deleted advanced or metastatic solid tumors including glioblastoma. Preclinical efficacy in MTAP-null xenografts demonstrated sustained tumor regressions in ~30% of models across histologies. Orthotopic GBM model showed antitumor activity. Combination with MAT2A or CDK4/6 inhibitors drove synergistic benefit in vitro and in vivo. References: 39756156

New Savolitinib + Osimertinib in Non-small cell lung cancer with EGFR+MET EGFR:Oncogenic mutations and MET:amplification: 3

Phase 2. Savolitinib Plus Osimertinib. N=30. EGFR-mutated, MET-amplified advanced NSCLC. ORR was 57% (Savolitinib + Osimertinib) versus 13% (Savolitinib + Placebo). Median PFS was 7.4 months versus 1.6 months. In higher MET cutoffs subgroup, ORR 63% versus 29%, Median PFS 8.2 months versus 4.0 months. References: 41308232

Removed AZD1390 + Radiotherapy in Non-small cell lung cancer with ATM alterations Protein expression: Tier 4   (First curated: 2020-04-16)

Changed AZD1390 + Radiotherapy with ATM Protein expression: 4

Cancer type(s) changed: Glioblastoma, Non-small cell lung cancer Comments changed: Preclinical study. Brain-penetrant ATM inhibitor AZD1390 combined with radiation induced tumor regressions and increased survival versus IR alone in syngeneic and patient-derived glioma and orthotopic lung-brain metastatic models.. (First curated: 2020-04-16)

Changed KIN-2787 in Solid tumours with BRAF Class II mutations, Class III mutations: 4

Comments changed: Preclinical study. KIN-2787 pan-RAF inhibitor. In vitro biochemical assays IC50 0.06-3.46 nM against RAF1, BRAF, and ARAF. Class II and III BRAF mutant cell lines IC50 < 50 nM; 19- and 7-fold more sensitive versus wild-type. In vivo xenografts (A-375, BxPC-3, WM3629) showed dose-dependent tumor growth inhibition (TGI up to 101-118%; p <=0.0001).. (First curated: 2022-11-29)

Changed Seribantumab in Solid tumours with NRG1 Fusion; CD74-NRG1 fusion; VAMP2-NRG1 fusion; SLC3A2-NRG1 fusion: 4

Comments changed: Preclinical study. Seribantumab effectively inhibits growth of patient-derived and isogenic cell line and xenograft models with NRG1 rearrangements in vitro and in vivo.. (First curated: 2021-03-31)

07 May, 2026 (Version: 20260507AU)

New Daraxonrasib in Pancreatic ductal adenocarcinoma with HRAS G12D: 3

Phase 1-2 study. NCT05379985. N=168. Daraxonrasib 300 mg in previously treated RAS-mutated PDAC. RAS G12 second-line subgroup ORR 35% (95% CI, 17 to 56). Median duration of response 8.2 months. Median PFS 8.5 months. Median OS 13.1 months. All RAS G12, G13, or Q61 mutations subgroup ORR 29%. Median PFS 8.1 months. Median OS 15.6 months. Supports ongoing Phase 3 RASolute 302 trial (NCT06625320). References: 42090791

New Daraxonrasib in Pancreatic ductal adenocarcinoma with KRAS G12, G12D, G12V, G12R, G12A, G12L, G12S, G13, Q61, Q61H, Oncogenic mutations: 3

Phase 1-2 study. NCT05379985. N=168. Daraxonrasib 300 mg in previously treated RAS-mutated PDAC. RAS G12 second-line subgroup ORR 35% (95% CI, 17 to 56). Median duration of response 8.2 months. Median PFS 8.5 months. Median OS 13.1 months. All RAS G12, G13, or Q61 mutations subgroup ORR 29%. Median PFS 8.1 months. Median OS 15.6 months. Supports ongoing Phase 3 RASolute 302 trial (NCT06625320). References: 42090791

New Panitumumab in Colorectal adenocarcinoma with KRAS+NRAS+BRAF+EGFR NOT KRAS:Oncogenic mutations AND NOT NRAS:Oncogenic mutations AND NOT BRAF:Oncogenic mutations AND NOT EGFR:Oncogenic mutations: R2

Phase 2 CHRONOS trial. NCT03227926. N=27 (52 screened). ctDNA-guided panitumumab rechallenge in tissue-RAS WT mCRC after prior anti-EGFR therapy. Primary endpoint ORR met (30% partial response). Disease control 63%. Results favorably compare with standard third-line treatments. Further larger randomized trials warranted. References: 35915157

Changed Trastuzumab deruxtecan in Non-small cell lung cancer with ERBB2 Oncogenic mutation: 1B

Tier changed: 1B2. Comments changed: TGA approved. Not PBS listed. Phase 2 trial. DESTINY-Lung02. NCT04961073. N=152. Dose optimization study. Confirmed ORR was 49% (Median DOR 16.8 months) and 56% (NE) in T-DXd 5.4mg/kg and 6.4 mg/kg respectively. Grade ≥3 treatment related adverse events occurred in 38.6% and 58% of patients receiving 5.4 and 6.4 mg/kg, respectively.. (First curated: 2023-11-05)

04 May, 2026 (Version: 20260504AU)

New Binimetinib + Encorafenib + Cetuximab in Colorectal adenocarcinoma with BRAF D594G: R2

Phase 2. BIG BANG. UMIN000031857. N=32. Binimetinib, encorafenib, and cetuximab in BRAF non-V600E mutated mCRC. Primary cohort (N=12) confirmed ORR 16.7%, Median PFS 3.3 months, Median OS 9.7 months. Anti-EGFR refractory cohort (N=20) confirmed ORR 10.0%, Median PFS 3.0 months, Median OS 7.6 months. Comparatively, class 1/2 tumors (N=7) ORR 28.6%. References: 10.1200/JCO.2024.42.16_suppl.3585

02 May, 2026 (Version: 20260502AU)

New Datopotamab deruxtecan in Non-small cell lung cancer with TACSTD2 Protein expression, Overexpression: 4

Exploratory biomarker analysis of ICARUS-LUNG01. N=100. Pretreated advanced NSCLC. Overall ORR 26.0% with Median PFS 3.6 months (NSQ 4.8 vs Sq 2.9 months). Median DoR 7.0 months. Median OS 11.9 months (Non-squamous 12.6 vs Sq 6.3 months). Standard IHC did not find association with ORR, but H score >= 100 higher (vs H-score < 100) was associated with higher PFS, requiring further validation. References: 41999747

30 April, 2026 (Version: 20260430AU)

Changed Futibatinib with FGFR2 Amplification: R2

Cancer type(s) changed: Gastric cancer, Gastroesophageal adenocarcinomaGastric cancer, Gastroesophageal junction cancer (First curated: 2026-04-23)

24 April, 2026 (Version: 20260424AU)

New Futibatinib in Gastric cancer, Gastroesophageal junction cancer with FGFR2 Amplification: R2

Phase 2 study. N=28. In patients with FGFR2 amplified gastric or GEJ cancer, futibatinib ORR was 17.9% (5 partial responses). Median DOR 3.9 months. DCR 50.0%. Median PFS 2.9 months. Median OS 5.9 months. Note, the lower bound of the 95% confidence interval (6.1%) falls below the 10% threshold. References: 39919334

23 April, 2026 (Version: 20260423AU)

New AMG 410 in Colorectal adenocarcinoma, Pancreatic adenocarcinoma, Non-small cell lung cancer, Solid Tumours with KRAS G12D, G12V, G12C, G13D, Amplification: 4

Preclinical study. Abstract ND01. AMG 410. Pan-KRAS inhibitor. Median IC50 12 nM in KRAS-mutant cells. Tumor stasis or regression observed in colorectal, pancreatic, and lung cancer CDX and PDX models harboring KRAS G12D, G12V, G12C, & G13D. Enhanced in vivo efficacy in combination with targeted therapies or immunotherapy. First-in-human study in solid tumor indications planned.'. References: 10.1158/1538-7445.AM2025-ND01

12 April, 2026 (Version: 20260412AU)

New Setidegrasib in Non-small cell lung cancer, Pancreatic adenocarcinoma with KRAS G12D: 3

Phase 1. NCT05382559. N=203. Setidegrasib 600 mg weekly in KRAS p.G12D-mutated advanced NSCLC and pancreatic ductal adenocarcinoma. NSCLC (n=45): ORR 36%, median PFS 8.3 months, 12-month OS 59%. Pancreatic (n=21): ORR 24%, median PFS 3.0 months, median OS 10.3 months, median DoR 4.2 months. Second- or third-line NSCLC subgroup (n=32): ORR 38%, median PFS 11.2 months. References: 41879829

10 April, 2026 (Version: 20260410AU)

New BH-30643 in Non-small cell lung cancer with EGFR Exon 19 deletion, Exon 19 deletion and T790M, Exon 19 deletion and T790M and C797S, L858R and T790M, L858R and T790M and C797S, G719A and S768I, G719A and L861Q, Exon 20 insertion: 4

Preclinical study. BH-30643. EGFR-mutant NSCLC CDX, PDX, and cell line models. In PC-9 (exon 19 del) CDX, BH-30643 led to deep tumor regressions similar to osimertinib at 25 mg/kg. Deep responses in double mutant CDX (cis L858R/T790M and exon 19 del/T790M). In triple-mutant PDX and CDX (cis exon 19 del/T790M/C797S and cis L858R/T790M/C797S), deep responses observed with BH-30643 while osimertinib showed no effect. Intracranial xenograft showed 90% tumor reduction. Atypical mutations (cis G719A/S768I and cis G719A/L861Q) maintained strong activity. EGFR ex20ins in 34 Ba/F3 cell lines showed median IC50 of 6.06 nM. First-in-human study NCT06706076 (SOLARA) ongoing.'. References: 10.1200/JCO.2025.43.16_suppl.3110

08 April, 2026 (Version: 20260408AU)

Changed Abemaciclib in Meningioma with CDKN2A Oncogenic mutation: 3

References changed: 41545592, 10.1200/JCO.2024.42.16_suppl.2001. (First curated: 2024-06-02)

07 April, 2026 (Version: 20260407AU)

New Everolimus + Bevacizumab in Malignant peripheral nerve sheath tumor with NF1 Oncogenic mutations; Loss-of-function mutations; Deletion: R2

Phase 2. SARC016. N=25 (17 NF1, 8 sporadic). Chemotherapy refractory MPNST. Everolimus plus bevacizumab. Clinical benefit rate (CR, PR, or SD >= 4 months) was 12% (3/25) failing activity threshold of 25%. Stage 1 1/15, Stage 2 2/10 additional. Median cycles 3. Combination not considered active. References: 31427883

New Everolimus in Non-small cell lung cancer with NF1 Oncogenic mutations; Loss-of-function mutations; Deletion: R2

Phase 2 basket study. N=12. Everolimus failed to meet prespecified ORR threshold of 30% (12.5% ORR including 1 CR with STK11) in patients with advanced solid malignancies harboring TSC1, TSC2, NF1, NF2 or STK11 mutations. 8 patients evaluable (4 STK11 and 4 NF1) for response with one response noted in STK11. No response seen in NSCLC NF1 mutants. References: 34422335

Changed Everolimus in Non-small cell lung cancer with STK11 Oncogenic mutations: 4

Comments changed: Phase 2 basket study. N=12. Everolimus failed to meet prespecified ORR threshold of 30% (12.5% ORR including 1 CR with STK11) in patients with advanced solid malignancies harboring TSC1, TSC2, NF1, NF2 or STK11 mutations. 8 patients evaluable (4 STK11 and 4 NF1) for response with one response noted in STK11.. (First curated: 2024-08-21)

03 April, 2026 (Version: 20260403AU)

New Bemarituzumab + mFOLFOX6 in Gastric cancer, Gastroesophageal junction adenocarcinoma with FGFR2 FGFR2b Overexpression, FGFR2-IIIb Overexpression: 3

Phase 2. FIGHT. NCT03694522. N=155. Bemarituzumab plus mFOLFOX6 median PFS 9.5 months versus placebo 7.4 months (HR 0.68; p=0.073) in FGFR2b-selected gastric or gastro-oesophageal junction adenocarcinoma. Primary endpoint not statistically significant but promising clinical efficacy observed. Confirmatory phase 3 trials planned. References: 36244398

New Bemarituzumab + mFOLFOX6 in Gastric cancer, Gastroesophageal junction adenocarcinoma with FGFR2 FGFR2b Overexpression, FGFR2-IIIb Overexpression: 3

Phase 3. FORTITUDE-101. NCT05052801. N=547. In FGFR2b ≥10% advanced Gastric and gastroesophageal cancer (Bemarituzumab n=159, Placebo n=165), bemarituzumab + mFOLFOX6 improved median OS vs placebo + mFOLFOX6 (17.9 vs 12.5 months; HR 0.61, P=0.005) at primary analysis. Median PFS 8.6 vs 6.7 months (HR 0.71, P=0.019). Follow-up analysis median OS 14.5 vs 13.2 months (HR 0.82). References: 10.1016/j.annonc.2025.09.092

New BG-C137 in Solid tumours, Gastric Cancer with FGFR2 FGFR2b Protein expression, FGFR2-IIIb Protein expression, FGFR2b Overexpression, FGFR2-IIIb Overexpression, FGFR2b Amplification, FGFR2-IIIb Amplification: 4

Preclinical study. BG-C137. FGFR2b-targeting ADC with topoisomerase inhibitor payload. In vitro and in vivo FGFR2b-expressing tumor models. Single dose showed strong anti-tumor efficacy in FGFR2b-amplified and non-amplified PDX models with strong bystander killing effect in vitro in heterogeneous FGFR2b expression models. References: 10.1158/1538-7445.AM2025-3778

Changed Bemarituzumab + FOLFOX in Gastric cancer, Gastroesophageal junction adenocarcinoma, Oesophageal adenocarcinoma with FGFR2 : 4

Alterations changed: Overexpression, FGFR2b Overexpression, FGFR2-IIIb OverexpressionOverexpression, FGFR2b:Overexpression, FGFR2-IIIb:Overexpression. (First curated: 2022-11-01)

Changed Bemarituzumab in Gastroesophageal junction adenocarcinoma, Gastric Cancer with FGFR2 : 4

Alterations changed: Overexpression, FGFR2b Overexpression, FGFR2-IIIb Overexpression, AmplificationOverexpression, FGFR2b:Overexpression, FGFR2-IIIb:Overexpression, amplification. (First curated: 2020-06-26)

Changed Olaparib with BRCA2 Oncogenic mutations: 3

Cancer type(s) changed: Breast cancer, Endometrial cancer, Other solid tumors (First curated: 2026-04-02)

Changed Olaparib with BRCA2 Oncogenic mutations: 4

Cancer type(s) changed: Biliary tract cancer, Non-small cell lung cancer, Small cell lung cancer, Gastric cancer, Ureteric carcinoma, Sarcoma, Oesophageal carcinoma, Duodenal adenocarcinoma, Neuroendocrine carcinoma, Solid tumoursBiliary tract cancer, Non-small cell lung cancer, Small cell lung cancer, Gastric cancer, Ureteric carcinoma, Sarcoma, Oesophageal carcinoma, Duodenal carcinoma, Neuroendocrine carcinoma, Solid tumours (First curated: 2026-04-02)

02 April, 2026 (Version: 20260402AU)

New MCB-294, MCB-36 in Solid tumours with KRAS G12D, G12C, G12V, G12S, G12A, G13D, V14I, L19F, Q22K, D33E, Q61H, K117N, A146V: 4

Preclinical study. MCB-294 dual-state pan-KRAS inhibitor and MCB-36 VHL-recruiting degrader demonstrated superior activity versus Bl-2865 and MRTX1133. Inhibited growth of KRAS-dependent cancer cells and patient-derived organoids. Reduced tumor progression in multiple preclinical models. Suppressed KRAS(G12C) inhibitor-resistant cancer cells. References: 40780213

New MCB-294, MCB-36 in Solid tumours with KRAS G10L, T58A, R68S: R2

Preclinical study. MCB-294 dual-state pan-KRAS inhibitor and MCB-36 VHL-recruiting degrader demonstrated superior activity versus Bl-2865 and MRTX1133. Inhibited growth of KRAS-dependent cancer cells and patient-derived organoids. Reduced tumor progression in multiple preclinical models. Suppressed KRAS(G12C) inhibitor-resistant cancer cells. References: 40780213

New Olaparib in Breast cancer, Endometrial cancer with BRCA1 Oncogenic mutations: 3

Phase 2 basket trial. TAPUR. NCT02693535. N=119. Olaparib evaluated in BRCA1/2-altered solid tumors across breast (n=28), biliary tract (n=19), lung (n=25), uterine (n=15), and histology-pooled (n=32) cohorts. Primary endpoint disease control (CR/PR/SD >= 16 weeks) rates were 69%, 50%, 41%, 47%, and 41% respectively, rejecting the null 15% DC rate hypothesis for all cohorts. Signal of activity declared for all cohorts. ORR of the Breast cancer cohort was 43% (12/28). ORR of the Endometrial cancer cohort was 20% (3/15). References: 41100773

New Olaparib in Breast cancer, Endometrial cancer, Other solid tumors with BRCA2 Oncogenic mutations: 3

Phase 2 basket trial. TAPUR. NCT02693535. N=119. Olaparib evaluated in BRCA1/2-altered solid tumors across breast (n=28), biliary tract (n=19), lung (n=25), uterine (n=15), and histology-pooled (n=32) cohorts. Primary endpoint disease control (CR/PR/SD >= 16 weeks) rates were 69%, 50%, 41%, 47%, and 41% respectively, rejecting the null 15% DC rate hypothesis for all cohorts. Signal of activity declared for all cohorts. ORR of the Breast cancer cohort was 43% (12/28). ORR of the Endometrial cancer cohort was 20% (3/15). References: 41100773

New Olaparib in Biliary tract cancer, Non-small cell lung cancer, Small cell lung cancer, Sweat gland carcinoma, Gastric cancer with BRCA1 Oncogenic mutations: 4

Phase 2 basket trial. TAPUR. NCT02693535. N=119. Olaparib evaluated in BRCA1/2-altered solid tumors across breast (n=28), biliary tract (n=19), lung (n=25), uterine (n=15), and histology-pooled (n=32) cohorts. Primary endpoint disease control (CR/PR/SD >= 16 weeks) rates were 69%, 50%, 41%, 47%, and 41% respectively, rejecting the null 15% DC rate hypothesis for all cohorts. Signal of activity declared for all cohorts. ORR of Biliary tract cancer was (2/19) 10% (0/6 gallbladder carcinoma). ORR for NSCLC is 2/17 (12%) and one (of 2) responder in SCLC. Responders seen in solid tumour cohort: sweat gland carcinoma, and gastric cancer. References: 41100773

New Olaparib in Biliary tract cancer, Non-small cell lung cancer, Small cell lung cancer, Gastric cancer, Ureteric carcinoma, Sarcoma, Oesophageal carcinoma, Duodenal carcinoma, Neuroendocrine carcinoma, Solid tumours with BRCA2 Oncogenic mutations: 4

Phase 2 basket trial. TAPUR. NCT02693535. N=119. Olaparib evaluated in BRCA1/2-altered solid tumors across breast (n=28), biliary tract (n=19), lung (n=25), uterine (n=15), and histology-pooled (n=32) cohorts. Primary endpoint disease control (CR/PR/SD >= 16 weeks) rates were 69%, 50%, 41%, 47%, and 41% respectively, rejecting the null 15% DC rate hypothesis for all cohorts. Signal of activity declared for all cohorts. ORR of Biliary tract cancer was (2/19) 10%. (0/6 gallbladder carcinoma). ORR for NSCLC is 2/17 (12%) and one (of 2) responder in SCLC. Responders seen in solid tumour cohort: gastric cancer, ureteric carcinoma, Sarcoma, Oesophageal carcinoma, Duodenal carcinoma, Neuroendocrine carcinoma. References: 41100773

New Capivasertib + Abiraterone in Prostate cancer with PTEN Loss of protein expression: 2

Phase 3 CAPItello-281 trial. NCT04493853. N=1012. In PTEN-deficient metastatic hormone-sensitive prostate cancer, capivasertib plus abiraterone improved rPFS versus placebo plus abiraterone (median 33.2 versus 25.7 months; HR 0.81, 95% CI 0.66-0.98, P = 0.034). OS HR was 0.90 (95% CI 0.71-1.15, P = 0.401) at 26.4% maturity. Post hoc rPFS analyses for PTEN loss cut-offs ≥95%, ≥99%, and 100% showed consistent treatment arm performance with numerically improved treatment effect as cut-off increased. References: 41120017

Changed Puxitatug samrotecan in Solid tumoursProtein expression: 3

Biomarker changed: VTCN1VCTN1. (First curated: 2024-09-14)

Changed BBO-11818 + Cetuximab in Colorectal adenocarcinoma with KRAS G12D: 4

References changed: 4179003210.1158/2159-8290.CD-25-1280. (First curated: 2026-03-11)

Changed BBO-11818 in Solid tumours with KRAS G12D, G12V, G12C, G12A, G12S, G13D, Amplification and NOT Oncogenic mutation: 4

References changed: 4179003210.1158/2159-8290.CD-25-1280. (First curated: 2026-03-11)

Changed BBO-11818 in Solid tumours with BRAF V600E: R2

References changed: 4179003210.1158/2159-8290.CD-25-1280. (First curated: 2026-03-11)

Changed BBO-11818 in Solid tumours with KRAS G12R, Q61R, Q61: R2

References changed: 4179003210.1158/2159-8290.CD-25-1280. (First curated: 2026-03-11)

Changed BBO-11818 in Solid tumours with NRAS Oncogenic mutations: R2

References changed: 4179003210.1158/2159-8290.CD-25-1280. (First curated: 2026-03-11)

16 March, 2026 (Version: 20260316AU)

Changed Niraparib with BAP1 Oncogenic mutations: R2

Cancer type(s) changed: Solid tumours except Mesothelioma (First curated: 2022-06-04)

12 March, 2026 (Version: 20260312AU)

Changed Amivantamab in Non-small cell lung cancer with EGFR Exon 20 insertion: 1

Tier changed: 1B. (First curated: 2021-05-22)

Changed Amivantamab + Carboplatin + Pemetrexed in Non-small cell lung cancer with EGFR Exon 20 insertion: 1

Tier changed: 1B. (First curated: 2023-10-29)

11 March, 2026 (Version: 20260311AU)

New BBO-11818 + Cetuximab in Colorectal adenocarcinoma with KRAS G12D: 4

Preclinical study. BBO-11818. Potent noncovalent pan-KRAS inhibitor targeting ON and OFF states of KRAS G12D, G12V, and G12C. Potently inhibited MAPK signaling and cellular viability in KRAS-driven cell lines. Produced tumor regressions in KRAS-mutant xenograft models. Enhanced efficacy observed in combination with anti-PD-1, anti-EGFR antibodies, and RAS:PI3Kα breaker. References: 10.1158/2159-8290.CD-25-1280

New BBO-11818 in Solid tumours with KRAS G12D, G12V, G12C, G12A, G12S, G13D, Amplification and NOT Oncogenic mutation: 4

Preclinical study. BBO-11818. Potent noncovalent pan-KRAS inhibitor targeting ON and OFF states of KRAS G12D, G12V, and G12C. Potently inhibited MAPK signaling and cellular viability in KRAS-driven cell lines. Produced tumor regressions in KRAS-mutant xenograft models. Enhanced efficacy observed in combination with anti-PD-1, anti-EGFR antibodies, and RAS:PI3Kα breaker. References: 10.1158/2159-8290.CD-25-1280

New BBO-11818 in Solid tumours with BRAF V600E: R2

Preclinical study. BBO-11818. Potent noncovalent pan-KRAS inhibitor targeting ON and OFF states of KRAS G12D, G12V, and G12C. Potently inhibited MAPK signaling and cellular viability in KRAS-driven cell lines. Produced tumor regressions in KRAS-mutant xenograft models. Enhanced efficacy observed in combination with anti-PD-1, anti-EGFR antibodies, and RAS:PI3Kα breaker. References: 10.1158/2159-8290.CD-25-1280

New BBO-11818 in Solid tumours with KRAS G12R, Q61R, Q61: R2

Preclinical study. BBO-11818. Potent noncovalent pan-KRAS inhibitor targeting ON and OFF states of KRAS G12D, G12V, and G12C. Potently inhibited MAPK signaling and cellular viability in KRAS-driven cell lines. Produced tumor regressions in KRAS-mutant xenograft models. Enhanced efficacy observed in combination with anti-PD-1, anti-EGFR antibodies, and RAS:PI3Kα breaker. References: 10.1158/2159-8290.CD-25-1280

New BBO-11818 in Solid tumours with NRAS Oncogenic mutations: R2

Preclinical study. BBO-11818. Potent noncovalent pan-KRAS inhibitor targeting ON and OFF states of KRAS G12D, G12V, and G12C. Potently inhibited MAPK signaling and cellular viability in KRAS-driven cell lines. Produced tumor regressions in KRAS-mutant xenograft models. Enhanced efficacy observed in combination with anti-PD-1, anti-EGFR antibodies, and RAS:PI3Kα breaker. References: 10.1158/2159-8290.CD-25-1280

Changed Larotrectinib with NTRK2 AFAP1-NTRK2 fusion: 3

Cancer type(s) changed: Solid tumoursSolid Tumors (First curated: 2025-08-21)

07 March, 2026 (Version: 20260307AU)

New Avelumab + Talazoparib in Ovarian cancer with BRCA1 Oncogenic mutations: 3

Phase 1b/2 basket trial. JAVELIN PARP Medley. NCT03330405. Avelumab plus talazoparib ORR was 63.6% in platinum-sensitive, BRCA1/2-altered OC (n=20, median PFS not reached, DOR not reached). Prolonged DOR in specific subtypes warrant further investigation in randomized clinical trials. References: 36394849

New Avelumab + Talazoparib in Ovarian cancer with BRCA2 Oncogenic mutations: 3

Phase 1b/2 basket trial. JAVELIN PARP Medley. NCT03330405. Avelumab plus talazoparib ORR was 63.6% in platinum-sensitive, BRCA1/2-altered OC (n=20, median PFS not reached, DOR not reached). Prolonged DOR in specific subtypes warrant further investigation in randomized clinical trials. References: 36394849

New Avelumab + Talazoparib in Breast cancer with ESR1+ERBB2+BRCA1 Oncogenic mutations: 3

Phase 1b/2 basket trial. JAVELIN PARP Medley. NCT03330405. Avelumab plus talazoparib ORR was 34.8% in HR-positive, ERBB2-negative, DDR-positive BC (n=23, median PFS 5.3 months, DOR 15.7 months)Prolonged DOR in specific subtypes warrant further investigation in randomized clinical trials. References: 36394849

New Avelumab + Talazoparib in Breast cancer with ESR1+ERBB2+BRCA2 Oncogenic mutations: 3

Phase 1b/2 basket trial. JAVELIN PARP Medley. NCT03330405. Avelumab plus talazoparib ORR was 34.8% in HR-positive, ERBB2-negative, DDR-positive BC (n=23, median PFS 5.3 months, DOR 15.7 months)Prolonged DOR in specific subtypes warrant further investigation in randomized clinical trials. References: 36394849

05 March, 2026 (Version: 20260305AU)

New Nivolumab + Ipilimumab, Nivolumab in Solid tumours with Tumour Mutational Burden High: 3

Phase 2. CheckMate 848. NCT03668119. N=201. Randomized open-label. Advanced or metastatic solid tumors with high tumor mutational burden (tTMB-H or bTMB-H). Refractory to standard therapies. Randomized 2:1 to nivolumab plus ipilimumab or nivolumab monotherapy. In tTMB-H patients, ORR was 38.6% with nivolumab plus ipilimumab versus 29.8% with nivolumab monotherapy. In bTMB-H patients, ORR was 22.5% with nivolumab plus ipilimumab versus 15.6% with nivolumab monotherapy. Early and durable responses observed with combination therapy. References: 39107131

New Sotorasib, RM-018, RMC-7977 in Solid tumours with KRAS H95L: 4

Retrospective genomic analysis and preclinical study. N=143. KRASG12C mutated NSCLC and CRC treated with KRASG12C inhibitors. 46% developed RAS/MAPK alterations post-progression (CRC 69% vs NSCLC 26%). Preclinical efficacy demonstrated RM-018 activity against switch-II pocket mutations, Pan KRAS-IN-1 targeting KRAS-activating mutations, and RMC-7797 high potency across all RAS alterations. References: 39914665

New Sotorasib, Divarasib, RM-018, RMC-7977 in Solid tumours with KRAS M72I: 4

Retrospective genomic analysis and preclinical study. N=143. KRASG12C mutated NSCLC and CRC treated with KRASG12C inhibitors. 46% developed RAS/MAPK alterations post-progression (CRC 69% vs NSCLC 26%). Preclinical efficacy demonstrated RM-018 activity against switch-II pocket mutations, Pan KRAS-IN-1 targeting KRAS-activating mutations, and RMC-7797 high potency across all RAS alterations. References: 39914665

New Sotorasib, Adagrasib, Divarasib, RM-018, RMC-7977 in Solid tumours with KRAS Q99L: 4

Retrospective genomic analysis and preclinical study. N=143. KRASG12C mutated NSCLC and CRC treated with KRASG12C inhibitors. 46% developed RAS/MAPK alterations post-progression (CRC 69% vs NSCLC 26%). Preclinical efficacy demonstrated RM-018 activity against switch-II pocket mutations, Pan KRAS-IN-1 targeting KRAS-activating mutations, and RMC-7797 high potency across all RAS alterations. References: 39914665

New RM-018, RMC-7977 in Solid tumours with KRAS R68S: 4

Retrospective genomic analysis and preclinical study. N=143. KRASG12C mutated NSCLC and CRC treated with KRASG12C inhibitors. 46% developed RAS/MAPK alterations post-progression (CRC 69% vs NSCLC 26%). Preclinical efficacy demonstrated RM-018 activity against switch-II pocket mutations, Pan KRAS-IN-1 targeting KRAS-activating mutations, and RMC-7797 high potency across all RAS alterations. References: 39914665

New RM-018, RMC-7977 in Solid tumours with KRAS Y96D: 4

Retrospective genomic analysis and preclinical study. N=143. KRASG12C mutated NSCLC and CRC treated with KRASG12C inhibitors. 46% developed RAS/MAPK alterations post-progression (CRC 69% vs NSCLC 26%). Preclinical efficacy demonstrated RM-018 activity against switch-II pocket mutations, Pan KRAS-IN-1 targeting KRAS-activating mutations, and RMC-7797 high potency across all RAS alterations. References: 39914665

New Sotorasib, Adagrasib, Divarasib in Non-small cell lung cancer, Colorectal adenocarcinoma with ARAF R544L: R2

Retrospective genomic analysis and preclinical study. N=143. KRASG12C mutated NSCLC and CRC treated with KRASG12C inhibitors. 46% developed RAS/MAPK alterations post-progression (CRC 69% vs NSCLC 26%). Preclinical efficacy demonstrated RM-018 activity against switch-II pocket mutations, Pan KRAS-IN-1 targeting KRAS-activating mutations, and RMC-7797 high potency across all RAS alterations. References: 39914665

New Sotorasib, Adagrasib, Divarasib in Non-small cell lung cancer, Colorectal adenocarcinoma with BRAF V600E, Fusion, K601E, E275D, G469A, G596C, L597R, L597Q: R2

Retrospective genomic analysis and preclinical study. N=143. KRASG12C mutated NSCLC and CRC treated with KRASG12C inhibitors. 46% developed RAS/MAPK alterations post-progression (CRC 69% vs NSCLC 26%). Preclinical efficacy demonstrated RM-018 activity against switch-II pocket mutations, Pan KRAS-IN-1 targeting KRAS-activating mutations, and RMC-7797 high potency across all RAS alterations. References: 39914665

New Sotorasib, Adagrasib, Divarasib in Non-small cell lung cancer, Colorectal adenocarcinoma with GNAS K216N: R2

Retrospective genomic analysis and preclinical study. N=143. KRASG12C mutated NSCLC and CRC treated with KRASG12C inhibitors. 46% developed RAS/MAPK alterations post-progression (CRC 69% vs NSCLC 26%). Preclinical efficacy demonstrated RM-018 activity against switch-II pocket mutations, Pan KRAS-IN-1 targeting KRAS-activating mutations, and RMC-7797 high potency across all RAS alterations. References: 39914665

New Sotorasib, Adagrasib, Divarasib in Non-small cell lung cancer, Colorectal adenocarcinoma with HRAS G13V: R2

Retrospective genomic analysis and preclinical study. N=143. KRASG12C mutated NSCLC and CRC treated with KRASG12C inhibitors. 46% developed RAS/MAPK alterations post-progression (CRC 69% vs NSCLC 26%). Preclinical efficacy demonstrated RM-018 activity against switch-II pocket mutations, Pan KRAS-IN-1 targeting KRAS-activating mutations, and RMC-7797 high potency across all RAS alterations. References: 39914665

New Sotorasib, Adagrasib, Divarasib in Non-small cell lung cancer, Colorectal adenocarcinoma with KRAS Amplification, G12D, G12V, Q61H, G13D, G12A, G12R, G12S, G12L, G12F, Q61L, V8L, G12W, A146P, A146T, H95R, Y96N, H95Q, Y96H, M72I, M72T, H95D, H95N: R2

Retrospective genomic analysis and preclinical study. N=143. KRASG12C mutated NSCLC and CRC treated with KRASG12C inhibitors. 46% developed RAS/MAPK alterations post-progression (CRC 69% vs NSCLC 26%). Preclinical efficacy demonstrated RM-018 activity against switch-II pocket mutations, Pan KRAS-IN-1 targeting KRAS-activating mutations, and RMC-7797 high potency across all RAS alterations. References: 39914665

New Adagrasib, Divarasib in Solid tumours with KRAS H95L: R2

Retrospective genomic analysis and preclinical study. N=143. KRASG12C mutated NSCLC and CRC treated with KRASG12C inhibitors. 46% developed RAS/MAPK alterations post-progression (CRC 69% vs NSCLC 26%). Preclinical efficacy demonstrated RM-018 activity against switch-II pocket mutations, Pan KRAS-IN-1 targeting KRAS-activating mutations, and RMC-7797 high potency across all RAS alterations. References: 39914665

New Adagrasib in Solid tumours with KRAS M72I: R2

Retrospective genomic analysis and preclinical study. N=143. KRASG12C mutated NSCLC and CRC treated with KRASG12C inhibitors. 46% developed RAS/MAPK alterations post-progression (CRC 69% vs NSCLC 26%). Preclinical efficacy demonstrated RM-018 activity against switch-II pocket mutations, Pan KRAS-IN-1 targeting KRAS-activating mutations, and RMC-7797 high potency across all RAS alterations. References: 39914665

New Sotorasib, Adagrasib, Divarasib in Solid tumours with KRAS R68S: R2

Retrospective genomic analysis and preclinical study. N=143. KRASG12C mutated NSCLC and CRC treated with KRASG12C inhibitors. 46% developed RAS/MAPK alterations post-progression (CRC 69% vs NSCLC 26%). Preclinical efficacy demonstrated RM-018 activity against switch-II pocket mutations, Pan KRAS-IN-1 targeting KRAS-activating mutations, and RMC-7797 high potency across all RAS alterations. References: 39914665

New Sotorasib, Adagrasib, Divarasib in Solid tumours with KRAS Y96D: R2

Retrospective genomic analysis and preclinical study. N=143. KRASG12C mutated NSCLC and CRC treated with KRASG12C inhibitors. 46% developed RAS/MAPK alterations post-progression (CRC 69% vs NSCLC 26%). Preclinical efficacy demonstrated RM-018 activity against switch-II pocket mutations, Pan KRAS-IN-1 targeting KRAS-activating mutations, and RMC-7797 high potency across all RAS alterations. References: 39914665

New Sotorasib, Adagrasib, Divarasib in Non-small cell lung cancer, Colorectal adenocarcinoma with MAP2K1 R47_E62delinsQ, Q56P, K57N, K57T, E102_I103del, E203K: R2

Retrospective genomic analysis and preclinical study. N=143. KRASG12C mutated NSCLC and CRC treated with KRASG12C inhibitors. 46% developed RAS/MAPK alterations post-progression (CRC 69% vs NSCLC 26%). Preclinical efficacy demonstrated RM-018 activity against switch-II pocket mutations, Pan KRAS-IN-1 targeting KRAS-activating mutations, and RMC-7797 high potency across all RAS alterations. References: 39914665

New Sotorasib, Adagrasib, Divarasib in Non-small cell lung cancer, Colorectal adenocarcinoma with NRAS Amplification, Q61K, Q61R, Q61L, Y96H, G13R, Q61H, A146V: R2

Retrospective genomic analysis and preclinical study. N=143. KRASG12C mutated NSCLC and CRC treated with KRASG12C inhibitors. 46% developed RAS/MAPK alterations post-progression (CRC 69% vs NSCLC 26%). Preclinical efficacy demonstrated RM-018 activity against switch-II pocket mutations, Pan KRAS-IN-1 targeting KRAS-activating mutations, and RMC-7797 high potency across all RAS alterations. References: 39914665

New Sotorasib, Adagrasib, Divarasib in Non-small cell lung cancer, Colorectal adenocarcinoma with RAF1 K53T: R2

Retrospective genomic analysis and preclinical study. N=143. KRASG12C mutated NSCLC and CRC treated with KRASG12C inhibitors. 46% developed RAS/MAPK alterations post-progression (CRC 69% vs NSCLC 26%). Preclinical efficacy demonstrated RM-018 activity against switch-II pocket mutations, Pan KRAS-IN-1 targeting KRAS-activating mutations, and RMC-7797 high potency across all RAS alterations. References: 39914665

Changed 9MW2821 in Solid Tumours, Urothelial carcinoma, Cervical Cancer, Oesophageal cancer, Triple-negative breast cancer with NECTIN4 Protein expression: 3

References changed: 40288679, 10.1200/JCO.2024.42.16_suppl.3013. (First curated: 2024-06-09)

04 March, 2026 (Version: 20260304AU)

New FOLFOXIRI + Panitumumab, FOLFOX + Panitumumab in Colorectal adenocarcinoma with KRAS+NRAS NOT KRAS:exon 2 mutation and NOT KRAS:exon 3 mutation and NOT KRAS:exon 4 mutation and NOT NRAS:exon 2 mutation and NOT NRAS:exon 3 mutation and NOT NRAS:exon 4 mutation: 1

Phase 3 TRIPLETE study. NCT03231722. N=435. Upfront mFOLFOXIRI plus panitumumab significantly improved OS (41.1 months) compared with mFOLFOX/panitumumab (33.3 months) in RAS/BRAF wild-type mCRC. ORR was 78% (experimental) vs 75% (control). No differences in PFS (HR, 0.95), early tumor shrinkage, depth of response, and no residual tumor resection rate. References: 41505697

New Fuzuloparib + Apatinib in Breast cancer with BRCA1+ERBB2 BRCA1:Oncogenic mutations (germline) AND NOT ERBB2:Amplification AND NOT ERBB2:Overexpression: 2

Phase 3 FABULOUS trial. NCT04296370. N=203. Fuzuloparib with apatinib significantly improved PFS (11.0 months) compared to fuzuloparib alone (6.7 months) and chemotherapy (3.0 months) in patients with HER2-negative metastatic breast cancer with germline BRCA1/2 mutations. Fuzuloparib-apatinib HR 0.27, p<0.0001; fuzuloparib HR 0.49, p=0.0004. References: 41308673

New Fuzuloparib + Apatinib in Breast cancer with BRCA2+ERBB2 BRCA2:Oncogenic mutations (germline) AND NOT ERBB2:Amplification AND NOT ERBB2:Overexpression: 2

Phase 3 FABULOUS trial. NCT04296370. N=203. Fuzuloparib with apatinib significantly improved PFS (11.0 months) compared to fuzuloparib alone (6.7 months) and chemotherapy (3.0 months) in patients with HER2-negative metastatic breast cancer with germline BRCA1/2 mutations. Fuzuloparib-apatinib HR 0.27, p<0.0001; fuzuloparib HR 0.49, p=0.0004. References: 41308673

New Eribulin + Trastuzumab + Pertuzumab in Breast cancer with ERBB2 Amplification, Overexpression: 2

Phase 3 EMERALD trial. NCT03264547. N=446. Trastuzumab-pertuzumab plus eribulin noninferior to taxane in first-line HER2+ breast cancer. Median PFS 14.0 months versus 12.9 months (HR, 0.95 [95% CI, 0.76 to 1.19]). Median OS not reached versus 65.3 months in taxane group. References: 39787453

New Tucatinib + Trastuzumab + Pertuzumab in Breast cancer with ERBB2 Amplification, Overexpression: 2

Phase 3. HER2CLIMB-05. NCT05132582. N=654. Tucatinib plus trastuzumab and pertuzumab versus placebo plus trastuzumab and pertuzumab as first-line maintenance therapy for HER2+ metastatic breast cancer. Investigator-assessed PFS significantly improved with tucatinib (24.9 v 16.3 months). PFS benefit observed regardless of brain metastasis presence or hormone receptor status. OS data immature. References: 41369677

New Zanidatamab + FOLFOX in Gastric cancer, Gastroesophageal junction adenocarcinoma with ERBB2 Amplification; Overexpression: 2

Not TGA approved. FDA approved (accelerated). Phase 2 trial. NCT03929666. N=46. Zanidatamab plus chemotherapy showed a confirmed objective response rate of 76.2% with a median duration of response of 18.7 months in HER2-positive advanced gastro-oesophageal adenocarcinoma. Median PFS was 12.5 months and median OS was 36.5 months. References: 40473445

New Abemaciclib + Fulvestrant in Breast cancer with ESR1+ERBB2 ESR1:Protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression: 2

Phase 3. postMONARCH. NCT05169567. N=368. Abemaciclib plus fulvestrant improved investigator-assessed PFS over placebo plus fulvestrant (HR 0.73; median 6.0 vs 5.3 months) in HR+, HER2- advanced breast cancer after CDK4/6i progression. BICR PFS HR 0.55. ORR 17% versus 7%. Consistent effect across ESR1 and PIK3CA mutation subgroups. References: 39693591

New Datopotamab deruxtecan in Breast cancer with ESR1+ERBB2 ESR1:Protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression: 2

FDA approved. Phase 3. TROPION-Breast01. NCT05104866. N=732. HR+/HER2- metastatic breast cancer. Dato-DXd significantly improved PFS versus chemotherapy (HR, 0.63). OS trend favored Dato-DXd (HR, 0.84). Consistent PFS benefit across subgroups. References: 39265124

New Sotorasib + Panitumumab in Colorectal adenocarcinoma with KRAS G12C: 2

FDA approved. Phase 3 CodeBreaK 300. NCT05198934. N=160. Sotorasib 960 mg-panitumumab significantly prolonged PFS versus investigator's choice in chemorefractory KRAS G12C mCRC. Updated ORR 30.2% (95% CI, 18.3 to 44.3) for 960 mg, 7.5% for 240 mg, and 1.9% for investigator's choice. OS HR 0.70 (95% CI, 0.41 to 1.18) for 960 mg and 0.83 (95% CI, 0.49 to 1.39) for 240 mg versus investigator's choice. Median follow-up 13.6 months. Findings support sotorasib 960 mg-panitumumab as standard of care. References: 40215429

New Taletrectinib in Non-small cell lung cancer with ROS1 Fusions; G2032R mutation: 2

Phase 2. TRUST-I and TRUST-II. NCT04919811 and NCT04395677. N=273. ROS1+ NSCLC. Taletrectinib in TKI-naive patients (n=160): cORR 88.8%, IC-cORR 76.5%, median DOR 44.2 months, median PFS 45.6 months. In TKI-pretreated patients (n=113): cORR 55.8%, IC-cORR 65.6%, median DOR 16.6 months, median PFS 9.7 months. G2032R mutation cORR 61.5% (8 of 13). References: 40179330

New Patritumab deruxtecan in Non-small cell lung cancer with ALK Fusion: 3

Phase 1/2. Patritumab Deruxtecan (HER3-DXd). N=47. Advanced NSCLC without common EGFR mutation progressed on platinum-based chemotherapy and immunotherapy. Primary endpoint cORR was 27.7% (95% CI, 15.6% to 42.6%). Median DOR 8.1 months. Median PFS 5.5 months. Median OS 15.2 months. Similar efficacy observed in patients with and without identified driver genomic alterations. References: 40554742

New Pivekimab sunirine in Blastic plasmacytoid dendritic cell neoplasm with CD123 Overexpression: 3

Phase 1/2. NCT03386513. Pivekimab sunirine (PVEK) showed a composite complete response rate of 75% in frontline de novo BPDCN patients, with median duration of response 10.6 months and median OS 16.6 months, and 53% proceeded to stem-cell transplant; in relapsed/refractory disease, CCR rate was 14%, with median duration 9.2 months and median OS 5.8 months. References: 41671533

New Camrelizumab + Famitinib, Camrelizumab in Cervical cancer with CD274 Protein expression: 3

Phase 2 randomized trial. NCT04680988. N=194. Camrelizumab plus famitinib versus camrelizumab in pretreated recurrent or metastatic cervical cancer. ORR per BICR significantly improved (41.0% vs 24.1%; P=.0181). Median PFS 8.1 vs 4.1 months. Median OS 20.2 vs 14.9 months. ORR benefit consistent across PD-L1 positive (44.6% vs 23.5%) and PD-L1 negative (35.0% vs 25.0%) subgroups, numerically higher in PD-L1 subgroup. Median DoR 16.0 months. References: 40561369

New Ifinatamab Deruxtecan in Small-cell lung cancer with CD276 Protein expression: 3

Phase 2 IDeate-Lung01 trial, NCT05280470, N=183, Ifinatamab Deruxtecan 12 mg/kg showed ORR of 48.2%, median DOR of 5.3 months, median PFS of 4.9 months, and 9-month OS estimate of 59.1%. Note no meaningful association was observed between B7-H3 expression by IHC and treatment response (Figure S1). References: 41086386

New CMG901 in Gastric cancer, Gastroesophageal junction adenocarcinoma with CLDN18 Protein expression: 3

Phase 1 KYM901 trial. NCT04805307. CMG901, a Claudin 18.2-targeting antibody-drug conjugate, antitumour activity in patients with advanced gastric or gastro-oesophageal junction cancer with confirmed ORR of 28% (32/113). CLDN18.2 positivity was defined as membrane staining intensity of >= 2+ in >= 5% of tumour cells in the the dose expansion phase. References: 39788133

New Obrixtamig in Small-cell lung cancer, Extrapulmonary neuroendocrine carcinoma, Large cell neuroendocrine carcinoma of the lung with DLL3 Protein expression: 3

Phase I dose-escalation. NCT04429087. Obrixtamig (BI 764532). N=168. DLL3-positive SCLC, epNECs, or LCNEC-L. 72% received ≥2 lines prior therapy. Overall ORR 23% (95% CI, 17.4% to 30.2%). Median DoR 8.5 months (95% CI, 6.2 to not reached). 6-month DoR rate 70%. Regimens B2/B3 ORR 28%. Subgroup ORRs for SCLC 21%, epNECs 27%, and LCNEC-L 70%. Supports further exploration in heavily pretreated DLL3-positive tumors. References: 40706016

New Amivantamab + Lazertinib in Non-small cell lung cancer with EGFR Exon 19 deletion, L858R, Exon 21 mutation: 3

Phase 1/1b. CHRYSALIS-2 trial. NCT04077463. N=105. Amivantamab plus lazertinib demonstrated antitumor activity in patients with atypical EGFR-mutated advanced NSCLC, with an ORR of 52%, mDoR of 14.1 months , and mPFS of 11.1 months. In treatment-naive patients, ORR was 57%, mPFS was 19.5 months, and mDoR was 20.7 months. In previously treated patients, ORR was 48%, mPFS was 7.8 months, and mDoR was 11.0 months. References: 41325571

New Sunvozertinib in Non-small cell lung cancer with EGFR Exon 20 insertion: 3

Phase II dose-randomized study. WU-KONG1B. NCT03974022. Sunvozertinib 200 mg or 300 mg. N=85, 89, 107 efficacy-evaluable patients across 200 mg-rand, 300 mg-rand, and 300 mg-all cohorts. Platinum-pretreated advanced NSCLC with EGFR exon20ins. Primary endpoint cORR was 45.9% (200 mg), 47.2% (300 mg-rand), and 45.8% (300 mg-all) per IRC. Null hypothesis rejected (P < .0001). DoR 13.8 months (300 mg) versus 11.1 months (200 mg). Subgroup cORR higher in baseline brain metastasis (52.4% v 28.6%) and prior amivantamab treatment (41.7% v 25%). Establishes efficacy for platinum-pretreated EGFR exon20ins NSCLC. References: 40923280

New Afatinib in Non-small cell lung cancer with EGFR G719X, L861Q, S768I, Exon 18 deletion, Exon 19 insertion, L747P, Oncogenic mutations and NOT Exon 20 insertion and NOT Exon 19 deletion and NOT L858R and NOT T790M: 3

Randomized open-label study. ACHILLES/TORG1834. jRCTs031180175. N=109. Treatment-naive nonsquamous NSCLC with uncommon EGFR mutations. Afatinib significantly improved median PFS over platinum-pemetrexed chemotherapy (10.6 vs 5.7 months; HR, 0.421; P = .0010). ORR was 61.4% for afatinib versus 47.1% for chemotherapy. Median DoR favored afatinib (10.6 vs 5.6 months; HR, 0.348). OS data immature. References: 40239133

New Patritumab deruxtecan in Non-small cell lung cancer with EGFR L861R, T751_I759delinsN, Oncogenic mutation AND NOT Exon 20 insertion: 3

Phase 1/2. Patritumab Deruxtecan (HER3-DXd). N=47. Advanced NSCLC without common EGFR mutation progressed on platinum-based chemotherapy and immunotherapy. Primary endpoint cORR was 27.7% (95% CI, 15.6% to 42.6%). Median DOR 8.1 months. Median PFS 5.5 months. Median OS 15.2 months. Similar efficacy observed in patients with and without identified driver genomic alterations. References: 40554742

New Patritumab deruxtecan in Non-small cell lung cancer with ERBB2 A775_G776insYVMA, D769Y: 3

Phase 1/2. Patritumab Deruxtecan (HER3-DXd). N=47. Advanced NSCLC without common EGFR mutation progressed on platinum-based chemotherapy and immunotherapy. Primary endpoint cORR was 27.7% (95% CI, 15.6% to 42.6%). Median DOR 8.1 months. Median PFS 5.5 months. Median OS 15.2 months. Similar efficacy observed in patients with and without identified driver genomic alterations. References: 40554742

New Zanidatamab + Palbociclib + Fulvestrant in Breast cancer with ERBB2+ESR1 ESR1:Protein expression AND ERBB2:Amplification, ESR1:Protein expression AND ERBB2:Overexpression: 3

Phase 2a study. NCT04224272. N=51. Zanidatamab plus palbociclib and fulvestrant showed promising antitumour activity with PFS at 6 months being 66.7% in heavily pretreated hormone receptor-positive, HER2-positive metastatic breast cancer patients. Most common adverse events were diarrhoea (80%) and neutropenia (51%). References: 40339592

New Ribociclib + Letrozole in Low-grade serous ovarian cancer with ESR1 Protein expression: 3

Phase 2 GOG 3026 trial. NCT03673124. N=49. Confirmed ORR was 30.6% with 1 complete and 14 partial responses. Median duration of response was 21.2 months. CBR was 84%. Median PFS was 14.5 months. Median OS was 44.5 months. ER not explicity required into the trial but >=95% of LGSOC are expected to have ER positivity. References: 41385758

New Camizestrant in Breast cancer with ESR1+ERBB2 ESR1:Protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression: 3

Phase 2 SERENA-3 trial. N=132. Camizestrant reduced ER expression by approximately 65% for all doses. Greater reduction in Ki67 expression was seen after 12-15 days compared to 5-7 days. Maximal effects on ER and Ki67 expression were achieved with camizestrant 75 mg once daily. References: 41628308

New Erdafitinib, Erdafitinib + Cetrelimab in Urothelial carcinoma with FGFR3 S249C, R248C, Y373C, G370C, Fusions, FGFR3-TACC3 fusion: 3

Phase 2 NORSE trial. NCT03473743. N=87. Erdafitinib monotherapy had an ORR of 44.2% with median DOR of 9.7 months, PFS of 5.6 months, and OS of 16.2 months. Erdafitinib plus cetrelimab had an ORR of 54.5% with median DOR of 11.1 months, PFS of 11.0 months, and OS of 20.8 months. References: 41538748

New Quizartinib in Acute myeloid leukaemia with FLT3 NOT Internal tandem duplication: 3

Phase 2 QUIWI trial. NCT04107727. N=273. Quizartinib significantly improved EFS (20.4 vs 9.9 months) and OS (not reached vs 29.3 months) compared to placebo in patients with FLT3-ITD-negative AML, with 3-year OS rates of 60.8% vs 45.7%. References: 41082703, 41325561

New Azacitidine + Venetoclax + Revumenib in Acute myeloid leukaemia with KMT2A Rearrangement: 3

Phase 1. NCT03013998. N=43. Azacitidine, venetoclax, and revumenib in newly diagnosed AML aged 60+ with NPM1m or KMT2Ar. ORR 88.4% (NPM1m 85.3%, KMT2Ar 100%). Composite CR 81.4% (NPM1m 79.4%, KMT2Ar 88.9%). CR 67.4% (NPM1m 65%, KMT2Ar 78%). Median time to response 28 days. 100% MRD negative in 37 evaluated patients. High rates of CR and clinical activity observed. References: 40504618

New Divarasib in Non-small cell lung cancer with KRAS G12C: 3

Phase I. GO42144. NCT04449874. N=65. Single-agent divarasib in advanced KRAS G12C-positive NSCLC. Confirmed ORR 55.6% (95% CI, 42.5 to 68.1) in measurable disease (n=63). Median DOR 18.0 months (95% CI, 11.1 to 24.9). Median PFS 13.8 months (95% CI, 9.8 to 25.4) overall and 15.3 months (95% CI, 12.3 to 26.1) at 400-mg dose. 48% treated beyond 1 year. References: 40632992

New Onvansertib + FOLFIRI + Bevacizumab in Colorectal adenocarcinoma with KRAS Oncogenic mutations: 3

Phase II. NCT03829410. N=53. Onvansertib + FOLFIRI + bevacizumab in KRAS-mutant mCRC. ORR 26.4%. Median DOR 11.7 months. No prior bevacizumab subgroup ORR 76.9% vs 10.0% and median PFS 14.9 months vs 6.6 months. First-line evaluation planned (NCT06106308). References: 39475591, 39561313

New Patritumab deruxtecan in Non-small cell lung cancer with KRSA G12: 3

Phase 1/2. Patritumab Deruxtecan (HER3-DXd). N=47. Advanced NSCLC without common EGFR mutation progressed on platinum-based chemotherapy and immunotherapy. Primary endpoint cORR was 27.7% (95% CI, 15.6% to 42.6%). Median DOR 8.1 months. Median PFS 5.5 months. Median OS 15.2 months. Similar efficacy observed in patients with and without identified driver genomic alterations. References: 40554742

New Azacitidine + Venetoclax + Revumenib in Acute myeloid leukaemia with NPM1 Oncogenic mutation: 3

Phase 1. NCT03013998. N=43. Azacitidine, venetoclax, and revumenib in newly diagnosed AML aged 60+ with NPM1m or KMT2Ar. ORR 88.4% (NPM1m 85.3%, KMT2Ar 100%). Composite CR 81.4% (NPM1m 79.4%, KMT2Ar 88.9%). CR 67.4% (NPM1m 65%, KMT2Ar 78%). Median time to response 28 days. 100% MRD negative in 37 evaluated patients. High rates of CR and clinical activity observed. References: 40504618

New Ziftomenib in Acute myeloid leukaemia with NPM1 Oncogenic mutation: 3

Phase II. KOMET-001. NCT04067336. N=92. Ziftomenib met primary endpoint CR/CRh rate 22% (95% CI, 14 to 32) in relapsed/refractory NPM1-mutated AML. ORR 33% (95% CI, 23 to 43). Median DOR 4.6 months (95% CI, 2.8 to 7.4). Median OS 6.6 months (95% CI, 3.6 to 8.6). 61% negative for measurable residual disease. Comparable CR/CRh regardless of prior venetoclax or comutations. References: 40997296

New Patritumab deruxtecan in Non-small cell lung cancer with NRAS Q61L: 3

Phase 1/2. Patritumab Deruxtecan (HER3-DXd). N=47. Advanced NSCLC without common EGFR mutation progressed on platinum-based chemotherapy and immunotherapy. Primary endpoint cORR was 27.7% (95% CI, 15.6% to 42.6%). Median DOR 8.1 months. Median PFS 5.5 months. Median OS 15.2 months. Similar efficacy observed in patients with and without identified driver genomic alterations. References: 40554742

New Patritumab deruxtecan in Non-small cell lung cancer with RET Fusion: 3

Phase 1/2. Patritumab Deruxtecan (HER3-DXd). N=47. Advanced NSCLC without common EGFR mutation progressed on platinum-based chemotherapy and immunotherapy. Primary endpoint cORR was 27.7% (95% CI, 15.6% to 42.6%). Median DOR 8.1 months. Median PFS 5.5 months. Median OS 15.2 months. Similar efficacy observed in patients with and without identified driver genomic alterations. References: 40554742

New Selpercatinib in Non-small cell lung cancer with RET KIF5B-RET fusion, CCDC6-RET fusion, NCOA4-RET fusion, Fusions: 3

Phase I/II. LIBRETTO-001. NCT03157128. N=316 (247 pretreated, 69 naive). Selpercatinib in RET fusion-positive NSCLC. ORR 62% pretreated, 83% naive. Median DoR 31.6 months pretreated, 20.3 months naive. Median PFS 26.2 months pretreated, 22.0 months naive. Median OS 47.6 months pretreated, not reached naive. 3-year OS 57% pretreated, 66% naive. CNS-ORR 85%, CNS-PFS 11.0 months. References: 39983053

New Patritumab deruxtecan in Non-small cell lung cancer with ROS1 Fusion: 3

Phase 1/2. Patritumab Deruxtecan (HER3-DXd). N=47. Advanced NSCLC without common EGFR mutation progressed on platinum-based chemotherapy and immunotherapy. Primary endpoint cORR was 27.7% (95% CI, 15.6% to 42.6%). Median DOR 8.1 months. Median PFS 5.5 months. Median OS 15.2 months. Similar efficacy observed in patients with and without identified driver genomic alterations. References: 40554742

New Adavosertib in Uterine serous carcinoma with CCNE1 Amplification, Protein expression: 4

Phase IIb, ADAGIO. NCT04590248. N=104. Adavosertib demonstrated an ORR by BICR of 26.0% in recurrent/persistent uterine serous carcinoma previously treated with platinum-based chemotherapy. Median DoR was 4.7 months. Median PFS was 2.8 months. Biomarker analysis identified no single predictive alteration, although a trend was observed for CCNE1 amplification or high cyclin E1 protein expression. References: 40262070

New FOR46 in Prostate cancer with CD46 Overexpression: 4

Phase I. FOR46 (FG-3246). NCT03575819. N=56. In patients with progressive mCRPC after ≥one androgen signaling inhibitors, median radiographic PFS was 8.7 months in efficacy evaluable subset (n=40). Confirmed ORR was 20% (5/25 RECIST-evaluable). PSA50 response was 36% (14/39). Median DOR was 7.5 months. Responders associated with higher on-treatment circulating effector CD8+ T cells. Note, Response was not clearly associated with CD46 expression despite mechanism of action. References: 40138611

New Patritumab deruxtecan in Non-small cell lung cancer with ERBB2 Amplification: 4

Phase 1/2. Patritumab Deruxtecan (HER3-DXd). N=47. Advanced NSCLC without common EGFR mutation progressed on platinum-based chemotherapy and immunotherapy. Primary endpoint cORR was 27.7% (95% CI, 15.6% to 42.6%). Median DOR 8.1 months. Median PFS 5.5 months. Median OS 15.2 months. Similar efficacy observed in patients with and without identified driver genomic alterations. Note 1 case of ERBB2 amplification had best response of PD. References: 40554742

New Cetuximab, Panitumumab in Colorectal adenocarcinoma with KRAS+NRAS+Consensus molecular subtype Consensus molecular subtype:CMS4 and NOT KRAS:exon 2 mutation and NOT KRAS:exon 3 mutation and NOT KRAS:exon 4 mutation and NOT NRAS:exon 2 mutation and NOT NRAS:exon 3 mutation and NOT NRAS:exon 4 mutation: 4

IPD Meta-Analysis. FIRE1, FIRE3, XELAVIRI, PanaMa, TRIBE2. N=790. RAS WT mCRC. CMS4 anti-EGFR vs anti-VEGF PFS HR 0.67 (P = .03), OS HR 0.49 (P < .001). CMS2/CMS4 vs CMS1 ORR OR 1.668/1.369, PFS HR 0.64/0.67, OS HR 0.59/0.67. Interaction test PFS/OS P < .001. CMS4 potential biomarker for anti-EGFR efficacy. References: 41252656

New Patritumab deruxtecan in Non-small cell lung cancer with MET Amplification: 4

Phase 1/2. Patritumab Deruxtecan (HER3-DXd). N=47. Advanced NSCLC without common EGFR mutation progressed on platinum-based chemotherapy and immunotherapy. Primary endpoint cORR was 27.7% (95% CI, 15.6% to 42.6%). Median DOR 8.1 months. Median PFS 5.5 months. Median OS 15.2 months. Similar efficacy observed in patients with and without identified driver genomic alterations. Note 1 case of MET amplification had best response of PD. References: 40554742

New Tislelizumab in Oesophageal squamous cell carcinoma with NOTCH1 Oncogenic mutations: 4

Biomarker analysis. Phase 3. RATIONALE-302. NCT03430843. In advanced/metastatic ESCC with NOTCH1 mutation, tislelizumab versus chemotherapy showed longer OS (18.4 months vs 5.3 months; HR, 0.35). IFN-I signatures positively associated with OS benefit, B-cell and neutrophil signatures predicted unfavorable OS.'. References: 40179324

New Atezolizumab + Bevacizumab + Cisplatin + Gemcitabine in Biliary tract cancer with VEGFA High gene expression: 4

Phase 2. IMbrave151. NCT04677504. N=162. BTCs respond poorly to PD-1/PD-L1 inhibitors. Atezolizumab (anti-PD-L1) plus bevacizumab plus cisplatin and gemcitabine versus atezolizumab plus placebo plus cisplatin and gemcitabine in untreated advanced BTC. Median PFS 8.3 months versus 7.9 months (HR, 0.67). Median OS 14.9 versus 14.6 months (HR, 0.97). High VEGFA gene expression associated with improved PFS (HR, 0.44). References: 39423355

New Ipilimumab + Nivolumab in Glioblastoma with MGMT Unmethylated: R2

Phase II/III. NRG Oncology BN007. NCT04396860. N=159. Ipilimumab and nivolumab did not improve PFS over temozolomide (7.7 versus 8.5 months, HR 1.47) or OS (median approximately 13 months each, HR 0.95) in newly diagnosed MGMT-unmethylated glioblastoma. Accrual closed permanently. References: 40779733

Changed Encorafenib + Binimetinib in Non-small cell lung cancer with BRAF V600E: 2

Comments changed: Not TGA approved. FDA approved. Phase 2, Open-Label Study of Encorafenib Plus Binimetinib in Patients With BRAFV600-Mutant Metastatic Non–Small-Cell Lung Cancer. NCT03148795. PHAROS. N=98. ORR was 75% (treatment naive) and 46% (previously treated). DCR after 24 weeks was 64% in treatment-naïve and 41% in previously treated patients. Median PFS was NE in treatment-naïve and 9.3 months in previously treated patients. Median OS 47.6 months in treatment-naive patients; 4-year OS probability 49%. Median OS 22.7 months in previously treated patients; 4-year OS probability 31%. Median duration of treatment 16.3 months (naive) and 5.5 months (treated).. References changed: 37270692, 41109959. (First curated: 2023-10-17)

Changed Rucaparib in Ovarian cancer, Peritoneal serous carcinoma, Fallopian tube carcinoma with BRCA1 Oncogenic mutations, Oncogenic mutations (germline): 2

Comments changed: Not TGA approved. NCT02855944. ARIEL4. Median PFS was significantly longer in rucaparib group than chemotherapy group (7.4 versus 5·7 months), including both platinum sensitive and resistant populations. Note, Rucaparib did not improve OS over chemotherapy (19.4 versus 25.4 months) in BRCA1/2-mutated relapsed ovarian cancer. 69% of patients in chemotherapy group crossed over to receive rucaparib.. References changed: 35298906, 39914419. (First curated: 2022-04-09)

Changed Rucaparib in Ovarian cancer, Peritoneal serous carcinoma, Fallopian tube carcinoma with BRCA2 Oncogenic mutations, Oncogenic mutations (germline): 2

Comments changed: Not TGA approved. NCT02855944. ARIEL4. Median PFS was significantly longer in rucaparib group than chemotherapy group (7.4 versus 5·7 months), including both platinum sensitive and resistant populations. Note, Rucaparib did not improve OS over chemotherapy (19.4 versus 25.4 months) in BRCA1/2-mutated relapsed ovarian cancer. 69% of patients in chemotherapy group crossed over to receive rucaparib.Not TGA approved. NCT02855944. Phase 3 ARIEL4 trial. NCT02855944. Median PFS was significantly longer in rucaparib group than chemotherapy group (7.4 versus 5.7 months) in patients with relapsed ovarian cancer and a deleterious BRCA1 or BRCA2 mutation.. References changed: 35298906, 39914419. (First curated: 2022-04-09)

Changed Zipalertinib in Non-small cell lung cancer with EGFR Exon 20 insertion: 2

References changed: 40450572, 10.1200/JCO-25-00763, 10.1200/JCO.2025.43.16_suppl.8503. (First curated: 2025-06-01)

Changed Vorasidenib in Low-grade gliomas with IDH1 Oncogenic mutation: 2

Comments changed: Phase 3. NCT04164901. INDIGO. N=331. Grade 2 with mutant IDH. Vorasidenib is associated with improvement with radiologic PFS 27.7 v 11.1 months and time to the next intervention (HR 0.26).. References changed: 37272516, 41175888. (First curated: 2023-06-05)

Changed Atezolizumab + Carboplatin + Paclitaxel in Endometrial cancer with Mismatch repair Deficient: 2

References changed: 39102832. (First curated: 2025-07-30)

Changed Zongertinib in Non-small cell lung cancer with ERBB2 Tyrosine kinase domain mutation, A775_G776insYVMA (Y772_A775dup), P780_Y781insGSP (G778_P780dup), G776delinsVC, L755P, G776V: 3

References changed: 40293180. (First curated: 2025-05-24)

Changed Zongertinib in Non-small cell lung cancer with ERBB2 Extracellular domain mutation, Transmembrane domain, Intracellular domain, S310F, S310Y, D277Y, S113F, V659E, G660D, P1199S: 4

References changed: 40293180. (First curated: 2025-05-24)

03 March, 2026 (Version: 20260303AU)

New Sacituzumab Govitecan + Pembrolizumab in Triple-negative breast cancer with CD274+ESR1+ERBB2 NOT ESR1:protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression and NOT CD274:protein expression: 2

Phase 3 ASCENT-04/KEYNOTE-D19. NCT05382286. N=443. Sacituzumab Govitecan + Pembrolizumab significantly prolonged PFS over chemotherapy + Pembrolizumab (11.2 vs 7.8 months) in previously untreated PD-L1–positive advanced TNBC. Objective response rate was 60% vs 53%; median DOR 16.5 vs 9.2 months. References: 41564397

New Trastuzumab + Pertuzumab + Palbociclib + Letrozole, Trastuzumab + Pertuzumab + Palbociclib + Anastrozole, Trastuzumab + Pertuzumab + Palbociclib + Fulvestrant in Breast cancer with ESR1+ERBB2 ESR1:Protein expression AND ERBB2:Amplification, ESR1:Protein expression AND ERBB2:Overexpression: 2

Phase 3. PATINA. NCT02947685. N=518. Addition of palbociclib to maintenance HER2-targeted and endocrine therapies significantly improved progression-free survival compared to standard therapy (median 44.3 vs 29.1 months). References: 41604639

New Tarlatamab in Small-cell lung cancer with DLL3 Protein expression: 2

Phase 3. DeLLphi-304 trial. NCT05740566. N=509. Tarlatamab significantly improved OS (13.6 vs 8.3 months) and PFS compared to chemotherapy (topotecan, lurbinectedin, or amrubicin) in patients with small-cell lung cancer after platinum-based chemotherapy. Note DLL3 expression is not required for entry into the trial. Treatment outcome was not evaluated against DLL3 expression. References: 40454646

New Camizestrant + Palbociclib, Camizestrant + Ribociclib, Camizestrant + Abemaciclib in Breast cancer with ERBB2+ESR1 ESR1:Protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression and ESR1:Oncogenic mutations, ESR1:D538G, ESR1:Y537S, ESR1:Y537N: 2

Not TGA approved. Phase 3 SERENA-6 trial, NCT04964934, N=315, ER-positive, HER2-negative advanced breast cancer, ESR1 mutation detected in ctDNA, patients switched to camizestrant (75mg daily) or continued aromatase inhibitor, both with CDK4/6 inhibitor, median PFS 16.0 months (camizestrant) vs 9.2 months (aromatase inhibitor). References: 40454637

New Trastuzumab deruxtecan + Pertuzumab in Breast cancer with ERBB2 Amplification, Overexpression: 2

Phase 3. DESTINY-Breast09 trial. NCT04784715. N=770. Trastuzumab deruxtecan plus pertuzumab significantly improved PFS (40.7 months) compared to taxane, trastuzumab, and pertuzumab (THP) (26.9 months) as first-line treatment for HER2-positive metastatic breast cancer. ORR was 85.1% with trastuzumab deruxtecan plus pertuzumab and 78.6% with THP. References: 41160818

New Trastuzumab deruxtecan in Gastric cancer, Gastroesophageal junction adenocarcinoma with ERBB2 Amplification, Overexpression: 2

Phase 3. DESTINY-Gastric04 trial. NCT04704934. N=494. Trastuzumab deruxtecan significantly improved OS (14.7 vs 11.4 months) and PFS over ramucirumab plus paclitaxel in HER2-positive metastatic gastric cancer, ORR 44.3% vs 29.1%. References: 40454632

New Zongertinib in Non-small cell lung cancer with ERBB2 Oncogenic mutations, Tyrosine kinase domain mutation, A775_G776insYVMA, P780_Y781insGSP, G776delinsVC, L755P, G776V, S310F, V659E: 3

Phase 1a-1b trial. NCT04886804. Zongertinib showed clinical benefit in patients with previously treated HER2-mutant NSCLC, with ORR of 71% (Cohort 1, 120mg dose), 48% (Cohort 5), and 30% (Cohort 3); Median PFS was 12.4 months (Cohort 1). References: 40293180

New Zongertinib in Non-small cell lung cancer with ERBB2 Extracellular domain mutation, S310Y, D277Y, S113F, Transmembrane domain mutations, G660D, Intracellular domain mutations, P1199S: 4

Phase 1a-1b trial. NCT04886804. Zongertinib showed clinical benefit in patients with previously treated HER2-mutant NSCLC. ORR was 30% (Cohort 3) with variable responses seen in selected extracellular, transmembrane, and intracellular domain mutations. References: 40293180

New Vepdegestrant in Breast cancer with ERBB2+ESR1 ESR1:Protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression; ESR1:Protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression and ESR1:Oncogenic mutations: 2

Phase 3 VERITAC-2 trial, NCT05654623, N=624, Vepdegestrant, a PROTAC ER degrader, significantly improved PFS over fulvestrant in ER-positive, HER2-negative advanced breast cancer patients with ESR1 mutations (5.0 vs 2.1 months, HR 0.58), but not in the overall population (3.8 vs 3.6 months, HR 0.83). References: 40454645

New Sacituzumab govitecan in Triple-negative breast cancer with ESR1+ERBB2 NOT ESR1:protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression: 2

Phase 3 ASCENT-03 trial, NCT05382299, N=558, Sacituzumab govitecan significantly improved PFS (9.7 months vs 6.9 months) over chemotherapy in patients with untreated advanced triple-negative breast cancer not eligible for PD-1/PD-L1 inhibitors, with similar ORR (48% vs 46%) and higher median duration of response (12.2 vs 7.2 months). References: 41124233

New Sevabertinib in Non-small cell lung cancer with ERBB2 Exon 20 insertions, A775_G776insYVMA, Oncogenic mutations,: 2

Phase 1-2 SOHO-01 trial, NCT05099172, N=209, Sevabertinib showed antitumor activity in HER2-mutant NSCLC patients with ORR of 64% (Cohort D), 38% (Cohort E), and 71% (Cohort F), with median PFS of 8.3 months, 5.5 months. References: 41104928

New Vebreltinib in Non-small cell lung cancer with MET Amplification: 3

Phase 2 KUNPENG trial. NCT04258033. N=86. Vebreltinib showed antitumour activity in patients with MET amplification-driven NSCLC, achieving an ORR of 48.8% (42/86) with a median follow-up of 18.6 months. MET amplification was determined by FISH with a gene copy number (GCN) >= 6 copies. No EGFR mutations, ALK fusion, ROS1 rearrangements, or KRAS mutations. References: 41365311

New Trastuzumab rezetecan in Non-small cell lung cancer with ERBB2 Exon 20 insertions, A775_G776insYVMA, G776delinsVC, P780_Y781insGSP, G776delinsLC: 3

Phase 2 HORIZON-Lung trial. NCT04818333. N=94. Trastuzumab rezetecan showed significant activity with an ORR of 73% in patients with advanced HER2-mutant NSCLC. References: 40020696

Changed Sacituzumab Govitecan in Triple-negative breast cancer with ESR1+ERBB2 : 1

Alterations changed: NOT ESR1:protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpressionNOT ESR1:protein expression and NOT ERBB2:amplified. (First curated: 2020-05-01)

Changed Amivantamab + Carboplatin + Pemetrexed, Amivantamab + Carboplatin + Pemetrexed + Lazertinib in Non-small cell lung cancer with EGFR Exon 19 deletion, L858R: 1B

Comments changed: Phase 3. NCT04988295. MARIPOSA-2: Amivantamab and chemotherapy with or without lazertinib prolonged PFS for EGFR-mutant advanced NSCLC patients after progression on osimeterinib, versus chemotherapy alone (median PFS by investigator, 8.3, 8.3, and 4.2 months). ORR was higher (64% and 63% vs 36%). OS for amivantamab-lazertinib was significantly improved (HR 0.75, 3-year OS 60% vs 51%), with increased grade 3 or higher adverse events (80% vs 52%).. References changed: 37879444, 40923797. (First curated: 2024-05-19)

Changed Osimertinib in Non-small cell lung cancer with EGFR Exon 19 deletion, L858R, Exon 21 mutation: 1B

Comments changed: Phase 3 FLAURA2 trial. NCT04035486. N=557. Combination of osimertinib with pemetrexed and a platinum agent led to significantly longer PFS over osimertinib monotherapy (19.3 v 11.2 months). ORR was similar between arms at 80% (osimertinib) and 84% (combination). Osimertinib plus chemotherapy significantly improved OS (47.5 months) compared to osimertinib monotherapy (37.6 months) in EGFR-mutated advanced NSCLC, with a HR of 0.77.. References changed: 37937763, 41104938. (First curated: 2023-11-09)

Changed Therapy in Colorectal adenocarcinoma with BRAF V600E: 2

Therapy changed: Encorafenib + Cetuximab + FOLFOXEncorafenib + Cetuximab + mFOLFOX6. Comments changed: TGA approved. PBS reimbursed. Phase 3 BREAKWATER trial. NCT04607421. Patients with untreated BRAF V600E-mutated metastatic colorectal cancer. EC+mFOLFOX6 showed significantly longer PFS (12.8 vs 7.1 months) and OS (30.3 vs 15.1 months) compared to standard care. Updated 2025-05-31.Not TGA approved. FDA approved. Phase 3 BREAKWATER trial (NCT04607421, N=637) demonstrated that encorafenib + cetuximab + mFOLFOX6 significantly improved outcomes compared to standard of care in previously untreated BRAF V600E-mutant metastatic colorectal cancer: ORR (60.9% vs 40.0%), median duration of response (13.9 vs 11.1 months), PFS (12.8 vs 7.1 months), and OS (30.3 vs 15.1 months). Updated 2025-05-31.. References changed: 40444708, 39863775, 10.1200/JCO.2025.43.16_suppl.LBA3500. (First curated: 2025-03-22)

Changed Sacituzumab tirumotecan in Non-small cell lung cancer with EGFR Exon 19 deletion, L858R, Exon 21 mutation: 2

Comments changed: Phase 3. OptiTROP-Lung04 trial. (NCT05870319). N=376. 1:1 to sac-TMT versus pemetrexed + platinum chemotherapy in EGFR-mutated, EGFR-TKI-Resistant NSCLC with progression on EGFR-TKIs. Sac-TMT demonstrated significantly longer PFS (8.3 vs 4.3 months) and improved 18-month OS (65.8% vs 48.0%) compared to platinum-based chemotherapy.Phase 3 OptiTROP-Lung04 trial. NCT05870319. N=376. Sacituzumab tirumotecan (Sac-TMT) significantly improved PFS (8.3 vs 4.3 months) and OS (not reached vs 17.4 months) compared to platinum-based chemotherapy in EGFR-mutated NSCLC following progression on EGFR-TKIs.. References changed: 41124220, ESMO25.LBA5. (First curated: 2025-10-19)

Changed Disitamab vedotin + Toripalimab in Urothelial carcinoma with ERBB2 Overexpression, Protein expression, Low protein expression: 2

Comments changed: Phase 3. RC48-C016 trial. NCT05302284. N=484. Disitamab vedotin + toripalimab significantly improved PFS (13.1 vs 6.5 months), OS (31.5 vs 16.9 months), and ORR (76.1% vs 50.2%) over chemotherapy in patients with untreated HER2-expressing locally advanced or metastatic urothelial carcinoma.Phase 3 RC48-C016 trial. NCT05302284. N=484. Disitamab vedotin + toripalimab significantly improved PFS (13.1 vs 6.5 months) and OS (31.5 vs 16.9 months) over chemotherapy in patients with HER2-expressing locally advanced or metastatic urothelial carcinoma.. References changed: 41124210, ESMO25.LBA7. (First curated: 2025-10-19)

Changed Therapy in Breast cancer with ESR1+ERBB2+PIK3CA ESR1:Protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression and PIK3CA:Oncogenic mutations: 2

Therapy changed: Inavolisib + Palbociclib + Fulvestrant. Comments changed: Not TGA approved. FDA approved. Phase 3. INAVO120 trial. NCT04191499. N=325. Inavolisib + palbociclib + fulvestrant significantly improved PFS2 (24.0 vs 15.1 months) and Time to first chemotherapy (not estimable vs 15.0 months) over placebo in patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced/metastatic breast cancer. OS improved (34.0 months vs 27.0 months).. References changed: 40454641, 10.1200/JCO.2024.42.16_suppl.1003. (First curated: 2024-10-13)

Changed Sacituzumab tirumotecan in Triple-negative breast cancer with ESR1+ERBB2 : 4

Alterations changed: NOT ESR1:protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpressionNOT ESR1:protein expression and NOT ERBB2:amplified, NOT ESR1:protein expression and NOT ERBB2:overexpression. (First curated: 2024-06-02)

Changed Rezatapopt with TP53 Y220C: 3

Cancer type(s) changed: Ovarian cancer, Solid tumours Tier changed: 34. Comments changed: Phase 1. PYNNACLE. NCT04585750. N=77. Across all dose groups, rezatapopt established. Overall response rate 20% (30% in KRAS wild-type tumors at ≥1150 mg), including confirmed responses in ovarian and breast cancers; all responders harbored TP53 Y220C and wild-type KRAS.PC14586 restored tumor suppressor function via conformational correction and DNA binding, supported by biochemical, structural, transcriptomic, and functional analyses, with potent antitumor activity in preclinical models as monotherapy and combined with immunotherapy.. (First curated: 2026-02-24)

24 February, 2026 (Version: 20260224AU)

New Rezatapopt in Solid tumours with TP53 Y220C: 4

PC14586 restored tumor suppressor function via conformational correction and DNA binding, supported by biochemical, structural, transcriptomic, and functional analyses, with potent antitumor activity in preclinical models as monotherapy and combined with immunotherapy. References: 39945593

New Cetuximab in Colorectal adenocarcinoma with KRAS Amplification: R2

Retrospective analysis. COH cohort and Flatiron cohorts. N=15. Wild-type RAS amplification in mCRC had median TTD 2.5 (COH) and 4.7 (CGDB) months vs 7.6 months in RAS wild-type, similar magnitude to EGFRmAb as RAS mutations. OS 11.4 vs 13.7 months. References: 33465286

06 February, 2026 (Version: 20260206AU)

New Olaparib in Solid Tumours with BRCA1 Oncogenic mutations: 3

Phase 2. Belgian Precision trial. BRCA1/2-mutated advanced cancers. N=27 (BRCA1) and 27 (BRCA2). ORR 11% (27 BRCA1: 3 PRs including pancreatic, gallbladder) and 21% (27 BRCA2: 5 PRs in pancreatic, parathyroid, and 1 CR in colon). Median PFS ≥14 months (5-34+ months in responders). CBR 63% (BRCA1) and 46% (BRCA2). References: 37852034

New Olaparib in Solid Tumours with BRCA2 Oncogenic mutations: 3

Phase 2. Belgian Precision trial. BRCA1/2-mutated advanced cancers. N=27 (BRCA1) and 27 (BRCA2). ORR 11% (27 BRCA1: 3 PRs including pancreatic, gallbladder) and 21% (27 BRCA2: 5 PRs in pancreatic, parathyroid, and 1 CR in colon). Median PFS ≥14 months (5-34+ months in responders). CBR 63% (BRCA1) and 46% (BRCA2). References: 37852034

New Olaparib in Solid Tumours with ATM Oncogenic mutations: R2

Phase 2. Belgian Precision. No clinical activity observed in ATM (n=13) or CHEK2 (n=14) cohorts. References: 37852034

New Olaparib in Solid Tumours with CHEK2 Oncogenic mutations: R2

Phase 2. Belgian Precision. No clinical activity observed in ATM (n=13) or CHEK2 (n=14) cohorts. References: 37852034

03 February, 2026 (Version: 20260203AU)

New Talazoparib in Hepatocellular carcinoma with BRCA1 Oncogenic mutations: 3

Phase 2 TAPUR Study. N=28. Talazoparib demonstrated antitumor activity in patients with BRCA1/2-mutated solid tumors, with a DCR of 57% and ORR of 36%, including responses in tumor types not currently approved for PARP inhibitors. References: 38865672

New Talazoparib in Prostate cancer, Cutaneous squamous cell carcinoma, Pancreatic adenocarcinoma, Gastric cancer, Oesophageal adenocarcinoma, Mesothelioma, Non-small cell lung cancer, Ovarian cancer, Endometrial cancer with BRCA2 Oncogenic mutations: 3

Phase 2 TAPUR Study. N=28. Talazoparib demonstrated antitumor activity in patients with BRCA1/2-mutated solid tumors, with a DCR of 57% and ORR of 36%, including responses in tumor types not currently approved for PARP inhibitors. References: 38865672

02 February, 2026 (Version: 20260202AU)

New PARP inhibitor in Prostate cancer, Ovarian cancer with Homologous Recombination Deficiency Score High: 4

Pan-cancer analysis of 260,333 samples identified 10 copy-number signatures associated with diverse processes, and a novel HRDsig that outperformed gLOH in predicting BRCAness. The PARPi benefit in was seen in clinicogenomic ovarian and prostate cancers. References: 37769224

New Olaparib in Chondrosarcoma, Solid tumours with IDH1 Oncogenic mutation: R2

Phase 2 study. NCT03212274. N=26. Olaparib did not demonstrate activity in IDH-mutant chondrosarcomas and other solid tumors with ORR 0%, median PFS of 2 months, and median OS of 7.5 months. References: 10.1200/JCO.2025.43.16_suppl.3087

New Olaparib in Chondrosarcoma, Solid tumours with IDH2 Oncogenic mutation: R2

Phase 2 study. NCT03212274. N=26. Olaparib did not demonstrate activity in IDH-mutant chondrosarcomas and other solid tumors with ORR 0%, median PFS of 2 months, and median OS of 7.5 months. References: 10.1200/JCO.2025.43.16_suppl.3087

19 January, 2026 (Version: 20260119AU)

Changed Capmatinib in Non-small cell lung cancer with MET : 4

Alterations changed: CD47-MET fusionCD74-MET fusion. (First curated: 2025-02-05)

15 December, 2025 (Version: 20251215AU)

New Sacituzumab tirumotecan in Non-small cell lung cancer with EGFR Exon 19 deletion, L858R, Exon 21 mutation: 2

Phase 3 OptiTROP-Lung04 trial. NCT05870319. N=376. Sacituzumab tirumotecan (Sac-TMT) significantly improved PFS (8.3 vs 4.3 months) and OS (not reached vs 17.4 months) compared to platinum-based chemotherapy in EGFR-mutated NSCLC following progression on EGFR-TKIs. References: ESMO25.LBA5

New Disitamab vedotin + Toripalimab in Urothelial carcinoma with ERBB2 Overexpression, Protein expression, Low protein expression: 2

Phase 3 RC48-C016 trial. NCT05302284. N=484. Disitamab vedotin + toripalimab significantly improved PFS (13.1 vs 6.5 months) and OS (31.5 vs 16.9 months) over chemotherapy in patients with HER2-expressing locally advanced or metastatic urothelial carcinoma. References: ESMO25.LBA7

New Giredestrant + Everolimus in Breast cancer with ERBB2+ESR1 ESR1:Protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression: 2

Phase 3 evERA BC trial. NCT05306340. N=373. Giredestrant + everolimus significantly improved PFS over SOC ET + everolimus (8.8 vs 5.5 months) in ER+, HER2- advanced breast cancer patients previously treated with a CDK4/6 inhibitor. References: ESMO25.LBA16

New Gedatolisib + Fulvestrant + Palbociclib, Gedatolisib + Fulvestrant, in Breast cancer with ERBB2+ESR1+PIK3CA PIK3CA:oncogenic mutations + ESR1:Protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression: 2

Phase 3 VIKTORIA-1 trial. NCT055001886. N=392. Gedatolisib + fulvestrant with or without palbociclib significantly improved PFS (9.3 vs 2.0 months)in HR+/HER2-/PIK3CA WT advanced breast cancer patients. ORR was 32% (triplet), 28.3% (doublet), and 1% (fulvestrant). References: ESMO25.LBA17

New Sacituzumab tirumotecan in Breast cancer with ESR1+ERBB2 ESR1:Protein expression and NOT ERBB2:amplification and NOT ERBB2:overexpression: 2

Phase 3 OptiTROP-Breast02 study. NCT06081959. N=399. Sacituzumab tirumotecan significantly improved PFS over investigator's choice of chemotherapy (8.3 vs 4.1 months) with a manageable safety profile in patients with previously treated HR+/HER2- breast cancer. References: ESMO25.LBA23

New HRS-7058 in Non-small cell lung cancer, Pancreatic adenocarcinoma, Colorectal adenocarcinoma, Solid tumour with KRAS G12C: 3

Phase 1 trial. NCT06383871. N=81. HRS-7058, a KRAS G12C inhibitor, showed promising antitumor activity with ORR of 48% and DCR of 94% in KRAS G12Ci-naive NSCLC. 3/4 patients with PDAC had tumour response. References: ESMO25.914O

New HRS-4642 in Non-small cell lung cancer, Pancreatic adenocarcinoma, Colorectal adenocarcinoma, Solid tumour with KRAS G12D: 3

Phase 1 trial. N=84. HRS-4642, a KRAS G12D inhibitor, showed activity in NSCLC (ORR 24%, mPFS 5.6 months) and PDAC (ORR 21%, mPFS 4.1 months). References: ESMO25.915O

New INCB161734 in Solid Tumours, Non-small cell lung cancer, Pancreatic adenocarcinoma, Colorectal adenocarcinoma, Ovarian cancer, Solid tumour with KRAS G12D: 3

Phase 1. NCT06179160. N=36. INCB161734, a KRAS G12D inhibitor showed promising efficacy in 36 patients with advanced or metastatic solid tumors, with ORR of 30%, and DCR of 85% achieving disease control at doses ≥600 mg qd (PDAC 34%). References: ESMO25.916O

New Telisotuzumab adizuteca in Solid tumours with MET Amplification: 3

Phase 1 study. NCT05029882. N=100. Temab-A monotherapy showed activities in patients with MET-amplified advanced solid tumors, with a confirmed ORR of 46% and median PFS of 9.5 months across all dose levels and tumor types, including NSCLC (69%) and GEA (71%). References: ESMO25.918O

New DS-3939 in Solid tumours with MUC1 Protein expression: 3

Phase 1/2 FIH study NCT05875168. N=47. DS-3939, a tumour associated-MUC1-directed ADC, showed early signal of clinical activity in pretreated patients with various solid tumors, with 10 confirmed partial responses observed across NSCLC, OC, and BC. References: ESMO25.917O

New SNV1521 in Breast cancer with BRCA2 Oncogenic mutations (germline): 4

Phase 1 trial. NCT06220864. N=32. SNV1521, a CNS-penetrant PARP1-selective inhibitor, showed encouraging anti-tumor activity with 5 responses in canonical tumors (PC/BC/OC/PDAC) and was well-tolerated with minimal hematologic toxicities. References: ESMO25.923MO

New AMT-116 in Solid tumours with CD44 Protein expression: 4

Phase 1/2 trials (NCT05725291; NCT06782334) of AMT-116, an anti-CD44v9 antibody-drug conjugate, showed manageable safety profile and promising antitumor activity across various solid tumors, with an ORR of 30% in EGFR wild-type NSCLC patients. References: ESMO25.922MO

New SNV1521 in Pancreatic adenocarcinoma with PALB2 Oncogenic mutations (germline): 4

Phase 1 trial. NCT06220864. N=32. SNV1521, a CNS-penetrant PARP1-selective inhibitor, showed encouraging anti-tumor activity with 5 responses in canonical tumors (PC/BC/OC/PDAC) and was well-tolerated with minimal hematologic toxicities. References: ESMO25.923MO

New SNV1521 in Ovarian cancer with RAD51D Oncogenic mutations (germline): 4

Phase 1 trial. NCT06220864. N=32. SNV1521, a CNS-penetrant PARP1-selective inhibitor, showed encouraging anti-tumor activity with 5 responses in canonical tumors (PC/BC/OC/PDAC) and was well-tolerated with minimal hematologic toxicities. References: ESMO25.923MO

New Cetuximab, Panitumumab in Colorectal adenocarcinoma with KRAS Amplification: R2

Case report. References: 28178681

New Cetuximab, Panitumumab, FOLFIRI + Cetuximab, Irinotecan + Cetuximab, FOLFOX + Panitumumab in Colorectal adenocarcinoma with NRAS Amplification: R2

Case report. References: 28178681

18 October, 2025 (Version: 20251018AU)

New Sevabertinib in Non-small cell lung cancer with ERBB2 Exon 20 insertions, A775_G776insYVMA, Tyrosine kinase domain mutations: 3

Phase 1/2. SOHO-01. NCT05099172. N=209. Three cohorts: D (previously treated without HER2-targeted therapy) had ORR 64%, median duration 9.2 months, PFS 8.3 months; E (previously received HER2 ADCs) ORR 38% with DOR duration 8.5 months, PFS 5.5 months; F (untreated) ORR 71% , with DOR 11.0 months, PFS immature. References: 10.1056/NEJMoa2511065

New Zongertinib in Non-small cell lung cancer with ERBB2 Exon 20 insertions, A775_G776insYVMA, Tyrosine kinase domain mutations: 3

Phase Ib. Beamion LUNG 1. NCT04886804. N=74. First-line zongertinib in treatment-naïve advanced HER2-mutant NSCLC showed ORR 77%, DOR 80%, PFS at 6 months 79%. References: ESMO25.LBA74

New MK-1084 in Non-small cell lung cancer, Colorectal cancer with KRAS G12C: 3

Phase I KANDLELIT-001 trial. NCT05067283. N=123. ORR 38% (CRC), 38% (NSCLC), 34% (others). Median PFS 6.2 (CRC), 8.3 (NSCLC), 5.7 mo. References: ESMO25.926MO

New Divarasib in Solid tumour except Colorectal adenocarcinoma, Non-small cell lung cancer, Pancreatic adenocarcinoma, Cholangiocarcinoma with KRAS G12C: 3

Phase 1. GO42144 (NCT04449874) and JO44179 (jRCT2031220195). N=32. Divarasib showed ORR of 34% (11/32) in KRAS G12C-positive non-NSCLC, non-CRC tumors (pancreatic: 27%, median PFS 7.1 mo; cholangiocarcinoma: 25%, median PFS 7.2 mo). Common TRAEs: diarrhea, nausea, anemia; no Grade 4-5 events. Updated TAPISTRY data (N=47) pending. Cholangiocarcinoma 23% (3/13); Pancreatic adenocarcinoma (31%). Other solid tumour (47%). References: ESMO25.927MO

New HRO761 in Colorectal adenocarcinoma with Microsatellite Instability High: 4

Phase I/Ib. HRO761. NCT05838768. N=47 (19 CRC). ORR 8.6% (10.5% in CRC), DCR 68.6% (84.2% in CRC), median PFS 5.6 months; 9-mo PFS rate 68.6% (95% CI 30.5–88.7) at 200 mg daily. ctDNA clearance observed in 6/14 pts with detectable baseline ctDNA, median treatment duration 9.3 months in responders. References: ESMO25.925MO