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, and Summit Therapeutics Inc. (NASDAQ:SMMT), a biopharmaceutical company focused on patient-friendly oncology therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs, today announced a clinical trial collaboration to evaluate the safety and efficacy of Arcus’s casdatifan, an investigational hypoxia-inducible factor 2-alpha (HIF-2α) inhibitor, in combination with Summit’s ivonescimab, an investigational PD-1/VEGF bispecific antibody, in clear cell renal cell carcinoma (ccRCC), including first-line metastatic disease, the most common form of kidney cancer.

"Combining casdatifan, a hard-hitting HIF-2α inhibitor, with ivonescimab, the most advanced and well-studied anti-PD-1/VEGF bispecific, presents a compelling opportunity to create a well-tolerated and TKI-sparing combination that has the potential to prolong survival," said Terry Rosen, Ph.D., Chief Executive Officer of Arcus. "Our development strategy is to establish casdatifan as a backbone therapy so that every patient has the opportunity to benefit from casdatifan across each line of therapy, and this collaboration enables the evaluation of a highly innovative regimen with strong scientific and clinical rationale to be an important first-line treatment for kidney cancer."

The clinical trial collaboration will evaluate casdatifan in combination with ivonescimab in a new cohort to be added to ARC-20, Arcus’s platform study, evaluating casdatifan alone or in combination with other potential treatment options across multiple cohorts in metastatic ccRCC. Under the terms of the agreement, Summit will supply ivonescimab and Arcus will conduct and sponsor the combination study. Both companies will contribute to the cost of the study, and each company will retain development and commercial rights to their respective molecules. Initial data from this clinical trial collaboration is expected to be generated by mid-2027.

"Ivonescimab’s novel mechanism of action targeting both the PD-1 axis and VEGF pathway is particularly compelling in renal cell carcinoma, where both pathways are known to play an important role in disease progression," said Dr. Maky Zanganeh, President and Co-Chief Executive Officer of Summit Therapeutics. "We are excited to get this work underway with Arcus to evaluate whether the combination of ivonescimab and casdatifan can translate into improved and more durable outcomes for patients. Despite recent advances, kidney cancer remains a disease area with stark stage-dependent survival where only a small proportion of patients survive beyond five years, highlighting the ongoing unmet need in this tumor setting."