Arcus' Casdatifan Shows Strong PFS in Late-Line Kidney Cancer — Arcus Biosciences, Inc.

Event summary

Arcus Biosciences presented new data for its HIF-2a inhibitor casdatifan, showing progression-free survival (PFS) beyond one year in late-line metastatic clear cell renal cell carcinoma (ccRCC).
The 100mg QD tablet cohort achieved a median PFS of 15.1 months and a confirmed overall response rate (cORR) of 45%.
Biomarker analysis linked deep and prolonged suppression of serum erythropoietin (sEPO) to clinical benefit, including improved ORR and PFS.
The data will be presented at the American Society of Clinical Oncology Genitourinary Cancer Symposium on February 28, 2026.

The big picture

Arcus' data positions casdatifan as a potential best-in-class HIF-2a inhibitor, addressing a significant unmet need in late-line ccRCC. The results highlight the importance of biomarker-driven drug development and could reshape treatment paradigms for kidney cancer. With fewer than 25% of patients responding to current monotherapy options, casdatifan's higher response rates represent a meaningful advancement.

What we're watching

Clinical Validation: Whether the Phase 3 PEAK-1 study will replicate these promising results and support regulatory approval.
Competitive Positioning: How casdatifan's efficacy compares to existing HIF-2a inhibitors in the late-line ccRCC market.
Commercial Strategy: The pace at which Arcus can secure partnerships or commercialize casdatifan globally, excluding Asia where Taiho holds rights.