AVEO to Collaborate with Bristol Myers on FOTIVDA-OPDIVO combo

 AVEO Oncology (Nasdaq: AVEO) today 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 3 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 3 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.

"With the recent U.S. FDA approval of FOTIVDA in the relapsed/refractory RCC setting, I look forward to further exploring FOTIVDA’s immunomodulatory effects and differentiated tolerability profile in combination with OPDIVO," said Toni Choueiri, M.D., Director, Lank Center for Genitourinary Oncology; Director, Kidney Cancer Center; Jerome and Nancy Kohlberg Chair and Professor of Medicine, Harvard Medical School, Dana-Farber Cancer Institute. "This combination was first explored in the Phase 1/2 TiNivo study, where it demonstrated favorable tolerability and prolonged PFS using the combination of FOTIVDA and OPDIVO in both treatment naïve and previously treated patients with advanced RCC. The TiNivo-2 Phase 3 study is expected to further our understanding of the activity and tolerability of this combination following prior immunotherapy."

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