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AVEO, Bristol Myers To Evaluate Fotivda - Opdivo In Phase 3 Trial In Relapsed Renal Cell Carcinoma

AVEO Oncology (AVEO) said Friday that it reached a clinical trial collaboration and supply agreement with Bristol Myers Squibb to evaluate Fotivda or tivozanib in combination with Opdivo or 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 or RCC following prior immunotherapy exposure.

Fotivda is an oral, next-generation vascular endothelial growth factor tyrosine kinase inhibitor approved for the treatment of adult patients with relapsed or refractory advanced RCC following two or more prior systemic therapies.

It is expected that the trial will enroll about 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, with key secondary endpoints to include overall survival, overall response rate and duration of response, and safety.

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.

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