Arcus Biosciences (NYSE: RCUS) announced a clinical supply agreement with AVEO Oncology, an LG Chem company, to evaluate the combination of casdatifan and tivozanib in patients with advanced kidney cancer who previously received HIF-2α inhibitor therapy.

Under the agreement, the two companies will add a new randomized cohort to Arcus's ARC-20 platform study, comparing casdatifan plus tivozanib (1.34 mg) against tivozanib alone in patients with advanced clear cell renal cell carcinoma (ccRCC). AVEO will supply tivozanib, while Arcus will conduct and sponsor the study. Each company retains development and commercial rights to its respective compounds. Enrollment is expected to begin in the fourth quarter of 2026.

Casdatifan is an investigational small-molecule HIF-2α inhibitor administered once daily in pill form. Tivozanib, marketed as FOTIVDA, is a vascular endothelial growth factor receptor tyrosine kinase inhibitor approved by the FDA in March 2021 for adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies.

Arcus is also enrolling patients in PEAK-1, a global Phase 3 study evaluating casdatifan plus cabozantinib versus cabozantinib alone in immunotherapy-experienced metastatic ccRCC. The company expects to complete enrollment in PEAK-1 and initiate a Phase 3 study in the first-line ccRCC setting by year-end 2026.

Casdatifan has not received regulatory approval, and its safety and efficacy have not been established. Taiho holds development and commercial rights to casdatifan in Japan and select Asian markets excluding China, with Arcus retaining rights elsewhere.