AVEO Oncology (NSDQ:AVEO) announced today that it entered into a clinical trial collaboration with Bristol Myers Squibb.
Boston-based AVEO’s collaboration and supply agreement with Bristol Myers Squibb is slated to evaluate Fotivda (tivozanib) in combination with Opdivo (nivolumab), an anti-PD-1 therapy developed by Bristol Myers Squibb.
The drugs will be evaluated in a pivotal Phase 3 trial in patients with advanced relapsed or refractory renal cell carcinoma (RCC) following prior immunotherapy exposure, according to a news release.
Fotivda is an oral, once-daily, vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) approved for treating patients with relapsed or refractory advanced RCC following one or more prior systemic therapies.
The TiNivo-2 Phase 3 trial for the drug combination is expected to enroll about 326 patients with advanced RCC who have progressed following prior immunotherapy treatment across sites in the U.S., Europe and Latin America. Patients will be randomized 1:1 to receive Fotivda in combination with Opdivo or Fotivda alone.
TiNivo-2’s primary endpoint will assess progression-free survival (PFS) with key secondary endpoints including overall survival, overall response rate and duration of response and safety. Bristol Myers Squibb will provide the supply of Opdivo while AVEO will serve as the study sponsor and will be responsible for costs associated with the trial’s execution.
“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,” AVEO president & CEO Michael Bailey said in the release. “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.
