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.

Key facts

Filed: Oct 20, 2026, 12:30 PM
Event: Topline results
Direction: Positive
Company: RCUSArcus Biosciences
Asset: casdatifan
Source: Company press release
Confidence: Sourced
1L cORR: 50%
2L cORR: 44%
2L mPFS: 14.5 months
2L 18mo OS: 77%
late line mOS: 35 months
late line cORR: 36%
late line mPFS: 13 months
1L mPFS landmark 6mo: 86%
1L mPFS landmark 12mo: 69%

Source excerpt

Arcus Presents New Data from ARC-20 that Demonstrate the Opportunity for Casdatifan to Become a Foundational Treatment Across All Lines of Therapy in Kidney Cancer Arcus Presents New Data from ARC-20 that Demonstrate the Opportunity for Casdatifan to Become a Foundational Treatment Across All Lines of Therapy in Kidney Cancer Arcus Presents New Data from ARC-20 that Demonstrate the Opportunity for Casdatifan to Become a Foundational Treatment Across All Lines of Therapy in Kidney Cancer Progression-free survival (PFS) for casdatifan plus anti-PD-1 in the first-line (1L) setting exceeded third-party benchmarks* for the approved anti-PD-1 plus anti-CTLA-4 regimen (ipilimumab plus nivolumab) and is similar to benchmarks for approved anti-PD-1 plus TKI regimens; the Phase 3 PEAK-20 study evaluating casdatifan plus ipilimumab and nivolumab is on track to start by year-end. PFS and overall survival (OS) in the second-line (2L) cohort evaluating casdatifan plus cabozantinib substantially exceeded benchmarks for cabozantinib monotherapy, including in patients who had previously progressed on TKIs; the ongoing Phase 3 PEAK-1 study is evaluating the same combination in the same patient population. An unprecedented nearly three-year median OS was reached in heavily pre-treated kidney cancer patients (majority third-line plus [3L+]) in the pooled monotherapy cohorts, exceeding the benchmark for the only approved HIF-2α inhibitor by more than one year; these data reinforce the potent

Company press release