RCUS Arcus Biosciences

Arcus presents updated casdatifan data from ARC-20 in 1L/2L/late-line ccRCC at conference

Arcus reported new clinical data from the ARC-20 platform study of casdatifan (HIF-2α inhibitor) in clear cell renal cell carcinoma. First-line casdatifan plus zimberelimab showed 50% cORR and 69% 12-month PFS; second-line casdatifan plus cabozantinib showed 14.5-month median PFS and 77% 18-month OS; late-line monotherapy showed 35-month median OS and 36% cORR. No unexpected safety signals observed.

Arcus Reports Positive ARC-20 Data for Casdatifan in 1L/2L/Late-Line ccRCC

New ARC-20 data show casdatifan plus zimberelimab exceeded immunotherapy benchmarks in 1L ccRCC (86%/69% 6/12-mo landmark PFS, 50% cORR). Casdatifan plus cabozantinib substantially exceeded cabozantinib benchmarks in 2L (14.5-mo mPFS, 77% 18-mo OS). Pooled monotherapy yielded unprecedented 35-mo mOS in heavily pretreated patients, exceeding the approved HIF-2α inhibitor benchmark by >1 year. Supports planned registrational trials including PEAK-20 (1L) by year-end 2026.

casdatifan · NCT07227415 registry update

countries: {'total_sites': 162, 'us_sites': 140} → {'total_sites': 183, 'us_sites': 160}

casdatifan · NCT07011719 registry update

countries: {'total_sites': 176, 'us_sites': 46} → {'total_sites': 183, 'us_sites': 46}

casdatifan · NCT07293351 registry update

countries: {'total_sites': 96, 'us_sites': 18} → {'total_sites': 95, 'us_sites': 17}

Arcus to present new casdatifan data in ccRCC at Oct 20 2026 investor event

Arcus will present new safety, efficacy (ORR, PFS, OS), subgroup, and translational data from the ARC-20 study of casdatifan in first-, second-, and late-line ccRCC, including combinations with zimberelimab, ipilimumab, and cabozantinib. The data will support initiation of Phase 3 PEAK-20 in Q4 2026 and full enrollment of Phase 3 PEAK-1 by end of 2026. This is an investor conference presentation, not a topline clinical readout or regulatory decision.