AVEO Oncology announces collaboration with BMS to evaluate Fotivda + Opdivo in pivotal phase III TiNivo-2 trial relapsed renal cell carcinoma.

AVEO Oncology announced that it has entered into a clinical trial collaboration and supply agreement with Bristol Myers Squibb to evaluate Fotivda (tivozanib) in combination with Opdivo (nivolumab), Bristol Myers Squibb’s anti-PD-1 therapy, in the pivotal Phase III TiNivo-2 trial in patients with advanced relapsed or refractory renal cell carcinoma (RCC) following prior immunotherapy exposure. Fotivda is an oral, next-generation vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) approved for the treatment of adult patients with relapsed or refractory advanced RCC following two or more prior systemic therapies.The randomized, open-label, controlled TiNivo-2 Phase III trial is expected to enroll approximately 326 patients with advanced RCC who have progressed following prior immunotherapy treatment. The study plans to enroll across clinical sites in the United States, Europe, and Latin America. Patients will be randomized 1:1 to receive either Fotivda (1.34 mg/QD for 21 days followed by 7 days off treatment) in combination with Opdivo (480 mg every 4 weeks) or Fotivda alone. The TiNivo-2 study’s primary endpoint will assess progression free survival (PFS), with key secondary endpoints to include overall survival, overall response rate and duration of response, and safety.