Arcus Biosciences Reports Casdatifan Kidney Cancer Data, With Nearly 3-Year Median Overall Survival In Heavily Pretreated Patients And Phase 3 Trials Remain Pending

• 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 potential for robust and durable HIF-2α inhibition to deliver a survival benefit across lines of therapy and support plans for a registrational trial to evaluate the combination of casdatifan plus tivozanib.

Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for the treatment of cancer and immune diseases, announced new data at an investor event in New York City from the ARC-20 platform study, which is evaluating casdatifan, an investigational next-generation HIF-2α inhibitor, alone or in combination, as a first-, second- and late-line treatment for clear cell renal cell carcinoma (ccRCC).