AVEO Oncology announced that it has completed enrollment in the pivotal Phase 3 TiNivo-2 study in patients with advanced relapsed or refractory renal cell carcinoma (RCC) following prior immunotherapy exposure. The study is evaluating FOTIVDA(R) (tivozanib) in combination with OPDIVO(R) (nivolumab), Bristol Myers Squibb's anti-PD-1 immunotherapy. FOTIVDA is an oral, next-generation vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) approved for the treatment of adult patients with RCC following two or more prior systemic therapies.

There are currently no National Comprehensive Cancer Network(R) (NCCN) Category 1 recommended agents for patients with advanced RCC who were previously treated with prior immunotherapy. All currently available treatment options for advanced RCC were approved based on clinical studies conducted prior to the introduction of frontline immunotherapy combinations. There is an unmet need to improve the understanding of treatment sequencing and provide new treatment regimens for advanced RCC.

The randomized, controlled, open-label TiNivo-2 Phase 3 study enrolled patients with RCC who have progressed following prior immunotherapy treatment. Patients were randomized 1:1 to receive either low dose FOTIVDA in combination with OPDIVO or standard dose FOTIVDA alone. The TiNivo-2 study's primary endpoint is progression free survival, with key secondary endpoints to include overall survival, overall response rate, duration of response and safety.

The TiNivo-2 study enrolled across clinical sites in the United States, Canada, Mexico, Europe and South America. The Company expects to share initial results from the TiNivo-2 study when the data mature, which is anticipated in the second half of 2024.