Arcus Biosciences, Inc. (NYSE: RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer and inflammatory and autoimmune diseases, today announced a clinical supply agreement with AVEO Oncology, an LG Chem company (“AVEO”). Under the agreement, the companies will evaluate casdatifan, Arcus’s investigational small-molecule HIF-2α inhibitor, in combination with tivozanib (FOTIVDA®), AVEO’s vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI), in a new randomized cohort within ARC-20, Arcus's platform study of casdatifan in patients with advanced clear cell renal cell carcinoma (ccRCC).

The new cohort in ARC-20 will evaluate casdatifan in combination with the recommended dose of tivozanib (1.34 mg) compared to tivozanib (1.34 mg) alone in patients with advanced ccRCC who received prior HIF-2α-inhibitor therapy. ARC-20 is a platform study evaluating casdatifan across multiple cohorts in metastatic ccRCC alone or in combination with other potential treatment options. Under the terms of the agreement, AVEO will supply tivozanib, and Arcus will conduct and sponsor the combination study. Each company will retain development and commercial rights to its respective compounds.

“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.”

This investigational therapy will be part of a holistic development strategy that is intended to provide physicians and patients with: 1) a casdatifan-based TKI-sparing first-line treatment; 2) a casdatifan-based TKI-inclusive first-line regimen; 3) a second-line HIF-2α-inhibitor treatment that builds on the second-line standard-of-care TKI, cabozantinib; and 4) a combination with a highly selective TKI therapy that can also provide benefit to patients previously treated with a HIF-2α inhibitor-based therapy.