Arcus Biosciences reports new casdatifan data for kidney cancer

Arcus Biosciences, Inc. presented new data from the ARC-20 platform study evaluating casdatifan for clear cell renal cell carcinoma on October 20, 2026. The company disclosed results across first-line, second-line, and late-line treatment settings in a Form 8-K filed with the U.S. Securities and Exchange Commission.

In the first-line TKI-free combination cohort, casdatifan paired with zimberelimab produced a landmark progression-free survival rate of 86% at six months and 69% at 12 months. The confirmed objective response rate was 50%, with a primary progression rate of 6.7% among the 30 patients in the group. Arcus stated that no unexpected safety signals were observed at the data cutoff of September 4, 2026.

For patients receiving the triplet combination of casdatifan, ipilimumab, and zimberelimab, primary progression occurred in only one of 24 patients who reached their first scan. The company reported no unexpected safety signals among the 31 enrolled patients who received at least one dose. Grade 3 and higher immune-mediated adverse events were described as consistent with those associated with ipilimumab and nivolumab in frequency, severity, and timing.

In the second-line setting, the combination of casdatifan and cabozantinib yielded a median progression-free survival of 14.5 months and an 18-month landmark overall survival of 77%. The confirmed objective response rate stood at 44%, while primary progression was recorded in 5% of the 43 patients with a median follow-up of 21.3 months. Arcus noted that efficacy was similar regardless of prior tyrosine kinase inhibitor therapy, a distinction relevant because TKI-pretreated patients represent approximately 60% of second-line cases in current practice.

Late-line monotherapy data from four pooled cohorts showed a median overall survival of 35 months and a median progression-free survival of 13 months among 121 patients. The confirmed objective response rate was 36%, with progression-free survival data remaining similar whether patients had received one, two, or three prior TKI-inclusive treatments. The company characterized the adverse events as acceptable and manageable across all doses without unexpected safety signals.

Terry Rosen, Ph.D., Chief Executive Officer of Arcus Biosciences, signed the report on October 20, 2026. The data cutoff for all reported metrics was September 4, 2026.