Arcus Biosciences partners with Bristol Myers Squibb on kidney cancer trial

Arcus Biosciences (NYSE: RCUS) announced a clinical trial collaboration and supply agreement with Bristol Myers Squibb (NYSE: BMY) to evaluate casdatifan in combination with an investigational cancer treatment for advanced renal cell carcinoma.

Under the agreement, Arcus will supply casdatifan, its investigational HIF-2a inhibitor, for inclusion in Bristol Myers Squibb's Phase 1/2 ROSETTA RCC-208 clinical trial. The trial will evaluate pumitamig, a PD-L1/VEGF-A bispecific antibody being jointly developed by BioNTech and Bristol Myers Squibb, alone or in combination with other treatments for advanced kidney cancer.

The collaboration will add two new treatment arms to the existing trial featuring casdatifan combinations. Each company retains development and commercial rights to their respective assets, and the agreement is mutually non-exclusive.

Casdatifan is designed to inhibit hypoxia-inducible factor 2-alpha, a protein that activates genes in response to low oxygen levels. In clear cell renal cell carcinoma, genetic abnormalities can dysregulate this protein and contribute to cancer development.

Arcus is conducting multiple studies with casdatifan, including the ARC-20 platform study evaluating various combinations across different treatment lines. The company is enrolling patients for PEAK-1, a Phase 3 study comparing casdatifan plus cabozantinib versus cabozantinib alone in immunotherapy-experienced metastatic clear cell renal cell carcinoma.

Arcus expects to complete enrollment in PEAK-1 and initiate a Phase 3 study in first-line metastatic clear cell renal cell carcinoma by year-end 2026. Taiho holds development and commercial rights for casdatifan in Japan and other Asian countries excluding China.

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