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
Key Highlights
- ➤35-month median OS for late-line monotherapy, with 52% receiving at least three prior therapies
- ➤Second-line combination reached 14.5-month median PFS and 77% 18-month OS
- ➤First-line casdatifan plus zimberelimab delivered 86% six-month and 69% 12-month PFS
- ➤PEAK-20 registrational trial of casdatifan plus ipilimumab and nivolumab targets Q4 2026 start
- ➤Arcus plans registrational casdatifan plus tivozanib trial versus tivozanib
Expert Statements
Rana McKay, Professor of medicine, urology, and radiation medicine and associate director of clinical sciences at the UC San Diego Moores Cancer Center
“Across the RCC treatment continuum, and in every setting in which it has been studied, casdatifan has shown rapid disease control, a meaningful impact on survival, and was tolerable, both alone and in combination with standard-of-care therapies”
Rana McKay, Professor of medicine, urology, and radiation medicine and associate director of clinical sciences at the UC San Diego Moores Cancer Center
“These are the attributes that matter most to physicians and patients.”
Richard Markus, Chief medical officer at Arcus Biosciences
“We are executing on a plan to develop casdatifan as a backbone therapy for all ccRCC patients.”
Richard Markus, Chief medical officer at Arcus Biosciences
“The disease control that has been observed for casdatifan plus anti-PD-1 in the first line, the remarkable benefit that has been observed for patients in the second line, even after progressing on prior TKI treatment, and unprecedented three-year median overall survival from casdatifan monotherapy in patients who had progressed on multiple prior therapies reveal for the first time the potential associated with deep and durable HIF-2α inhibition.”
Richard Markus, Chief medical officer at Arcus Biosciences
“We are on track to initiate our second registrational trial in ccRCC, the first-line PEAK-20 study, by the end of this year.”
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.
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