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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Hedge-fund billionaire William Ackman's Pershing Square Tontine Holdings Ltd. (PSTH) agreed to acquire 10% of Universal Music Group from French media conglomerate Vivendi (VIV.L, VIVEF.PK) for about $4 billion, the companies said in a statement on Sunday. The 737 MAX 10, Boeing Co.'s largest 737 Max model, is taking its maiden flight today, reports said citing people familiar with the matter. The flight after months of testing and certification will be around 10 a.m. local time from the Seattle area. The schedule could change depending on weather or other factors. Meanwhile, the jetliner is expected to enter commercial service in 2023. Medical devices supplier Smiths Medical, affiliated to Smiths Group plc, is recalling certain Jelco Hypodermic Needle-Pro Fixed Needle insulin syringes with skewed graduation markings, the U.S. Food and Drug Administration said. The recall was initiated after the company became aware of specific models and lots of Jelco insulin syringes that may exhibit skewed odd number line graduation markings.
Follow RTT