Clinical Pipeline

A new randomized cohort comparing casdatifan + tivozanib (FOTIVDA®) versus tivozanib within the ARC-20 platform study will evaluate casdatifan in combination with tivozanib, a VEGFR TKI, in patients with advanced clear cell renal cell carcinoma who were previously treated with a HIF-2α inhibitor. AVEO will supply tivozanib. This collaboration is non-exclusive, with both parties retaining independent development and commercial rights to their respective compounds.

Arcus will supply casdatifan for two new arms of Bristol Myers Squibb’s (BMS) Phase 1/2 ROSETTA RCC-208 study, evaluating casdatifan in combination with pumitamig, an investigational PD-L1/VEGF-A bispecific antibody jointly developed by BioNTech and BMS, in advanced renal cell carcinoma. This collaboration is non-exclusive, with both parties retaining independent development and commercial rights to their respective compounds.

Arcus will also supply casdatifan for an arm in Pfizer’s Symbiotic-GU-08 Phase 1b/2 platform study evaluating the combination of casdatifan with PF-4404, a PD-1/VEGF bispecific, in first-line, advanced renal cell carcinoma. This collaboration is non-exclusive, with both parties retaining independent development and commercial rights to their respective compounds.

A new cohort within Arcus’s ARC-20 platform study will evaluate casdatifan in combination with ivonescimab, an investigational PD-1/VEGF bispecific antibody, in first-line metastatic clear cell renal cell carcinoma. Summit will supply ivonescimab. This collaboration is non-exclusive, with both parties retaining independent development and commercial rights to their respective compounds.

Taiho has development and commercial rights in Japan and other countries in Asia, excluding China, for domvanalimab, zimberelimab, quemliclustat, etrumadenant and casdatifan. In Japan, Taiho is operationalizing the ongoing Phase 3 PRISM-1 registrational study for quemliclustat and participating in the ongoing Phase 3 PEAK-1 registrational study for casdatifan.