HAYWARD, Calif. — Arcus Biosciences Inc. has entered into a clinical supply agreement with AVEO Oncology to evaluate a combination of casdatifan and tivozanib in patients with advanced kidney cancer.
The companies will study Arcus’ investigational HIF-2α inhibitor casdatifan with AVEO’s VEGFR tyrosine kinase inhibitor tivozanib, marketed as FOTIVDA, in a new randomized cohort of the ARC-20 clinical trial.
The cohort will compare casdatifan plus the recommended 1.34-milligram dose of tivozanib with tivozanib alone in patients with advanced clear cell renal cell carcinoma who have previously received a HIF-2α inhibitor.
Enrollment is expected to begin in the fourth quarter of 2026.
Under the agreement, AVEO will supply tivozanib, while Arcus will sponsor and conduct the study. Each company will retain development and commercial rights to its respective drug.
“HIF-2α inhibition is emerging as an important standard of care in kidney cancer, and we believe that casdatifan, with its demonstrated pharmacokinetic/pharmacodynamic advantages, may extend benefit for patients who have progressed on a first-generation HIF-2α inhibitor,” said Terry Rosen, Ph.D., Chief Executive Officer of Arcus.
“This collaboration with AVEO, combining casdatifan with tivozanib, a VEGFR TKI with an established, distinct safety profile, will further our intent to establish casdatifan as a therapy that can benefit every patient across each line of therapy, and clarify the potential efficacy that casdatifan can bring in patients previously treated with a HIF-2α inhibitor-inclusive regimen.”
ARC-20 is a platform study evaluating casdatifan alone and in combination with other treatments across several groups of patients with metastatic clear cell renal cell carcinoma.
Casdatifan is a small-molecule inhibitor of hypoxia-inducible factor 2-alpha, or HIF-2α, a protein involved in the body’s response to low oxygen levels. Dysregulation of the HIF-2α pathway is associated with the development of clear cell renal cell carcinoma, the most common form of kidney cancer.
Arcus is also evaluating casdatifan in combinations with zimberelimab, ipilimumab, ivonescimab and cabozantinib.
The company is enrolling patients in PEAK-1, a global Phase 3 trial comparing casdatifan plus cabozantinib with cabozantinib alone in patients with metastatic clear cell renal cell carcinoma previously treated with immunotherapy.
Arcus expects to complete enrollment in PEAK-1 and begin another Phase 3 study of casdatifan in the first-line setting by the end of 2026.
Casdatifan remains investigational and has not been approved by any regulatory authority. Its safety and efficacy have not been established.
Tivozanib received U.S. Food and Drug Administration approval in March 2021 for adults with relapsed or refractory advanced renal cell carcinoma following at least two prior systemic therapies.
