Arcus Biosciences announced a clinical trial collaboration and supply agreement with Bristol Myers Squibb (BMS) to evaluate casdatifan, Arcus’s investigational small‑molecule HIF‑2a inhibitor, in advanced renal cell carcinoma (RCC). Under the agreement, casdatifan will be supplied for use in the BMS‑sponsored Phase 1/2 ROSETTA RCC‑208 trial, which is studying pumitamig (BNT327/BMS986545), an investigational PD‑L1/VEGF‑A bispecific antibody being jointly developed by BioNTech and BMS, alone or in combination with other potential treatment options in RCC.
As part of the collaboration, two new casdatifan‑containing arms will be added to the ROSETTA RCC‑208 study. Each company will retain development and commercial rights to its respective assets, and the collaboration is mutually non‑exclusive.
Terry Rosen, Ph.D., chief executive officer of Arcus, said the company’s goal is to generate evidence to establish casdatifan as a backbone therapy in kidney cancer so that patients can potentially benefit from the drug across each line of therapy. He noted that HIF‑2a inhibition and PD‑L1 and VEGF‑A blockade are validated mechanisms in kidney cancer, providing a strong biological rationale for combination, and described the collaboration with BMS as a top priority for Arcus to potentially deliver an additional TKI‑free option in the first‑line setting.
Arcus said the collaboration fits within its broader development strategy, which aims to offer physicians and patients: a casdatifan‑based, HIF‑2a inhibitor‑inclusive, TKI‑sparing first‑line regimen; a casdatifan‑based, TKI‑inclusive first‑line regimen; a second‑line HIF‑2a inhibitor treatment that builds on the second‑line standard‑of‑care TKI cabozantinib; and a late‑line therapy with clinical evidence of benefit even in patients previously treated with a HIF‑2a inhibitor‑based regimen.
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