Aveo Oncology initiates Phase III trial to compare tivozanib to sorafenib in treatment of refractory renal cell carcinoma.

AVEO Oncology has announced that the first patient has been dosed in the Company’s pivotal TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib (Nexavar) in subjects with refractory advanced renal cell carcinoma (RCC). Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI).The Phase III trial is expected to enroll approximately 322 patients with recurrent or metastatic RCC who have failed at least two prior regimens, including VEGFR-TKI therapy (other than sorafenib). Eligible patients may also have received checkpoint inhibitor therapy in earlier lines of treatment. Patients will be randomized 1:1 to receive either tivozanib or sorafenib, with no crossover between arms. The primary endpoint of the study is progression free survival. Secondary endpoints include overall survival, overall response rate, and safety and tolerability. Top line readout of the study is currently projected for the first quarter of 2018.

Comment:The TIVO-3 trial, together with the previously completed TIVO-1 trial of tivozanib in the first line treatment of RCC, is designed to support a first and third line indication for tivozanib in the U.S. Marketing authorization applications seeking approval of tivozanib as a treatment for first line renal cell cancer are currently pending in Europe and Russia based on applications submitted by AVEO’s partners EUSA Pharma and Pharmstandard in those respective territories.