Benzinga | Mar 12, 2021 07:00AM EST

AVEO Oncology Reports Collab With Bristol Myers To Evaluate FOTIVDA In Combo With OPDIVO For Trial Of Relapsed Renal Cancer Carcinoma Treatment

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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(r) (tivozanib) in combination with OPDIVO(r) (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 na?ve 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."

"The advanced RCC treatment landscape has seen significant benefit from the introduction of immunotherapy-VEGF TKI combinations in earlier-line treatment, and we believe that this benefit could extend to the relapsed/refractory setting with an effective, well-tolerated combination," said Michael Bailey, president and chief executive officer of AVEO. "On the heels of the recent U.S. FDA approval of FOTIVDA as monotherapy for the treatment of adult patients with relapsed or refractory advanced RCC following two or more prior systemic therapies, we are keenly interested in exploring its full potential in the combination setting. Working with our clinical collaborators and Bristol Myers Squibb, our goal is to advance this trial as expeditiously as possible."

Bristol Myers Squibb will provide OPDIVO clinical drug supply for the study. AVEO will serve as the study sponsor and will be responsible for costs associated with the trial execution.

OPDIVO(r) is a registered trademark of Bristol Myers Squibb.