AVEO Oncology announced that its pivotal, Phase 3 TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC), has successfully completed the first safety review by the study’s Safety Monitoring Committee (SMC). The SMC concluded that no safety concern was observed for tivozanib and recommended that the study replace the small number of patients who dropped out prior to starting treatment.
As recently announced, the TIVO-3 trial is enrolling substantially ahead of schedule, and with the SMC recommendation to replace early dropouts the Company still expects to complete enrollment in June 2017, ahead of its prior guidance of August 2017. A pre-planned futility analysis of the trial is expected around midyear 2017, with topline data expected in the first quarter of 2018. 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 regulatory approval of tivozanib in the U.S. as first and third line treatment for RCC.
“Tivozanib is a unique molecule in that its high selectivity for VEGF is designed to reduce off target toxicity, thereby increasing tolerability and its combinability with other agents, such as immunotherapies,” said Michael Needle, M.D., chief medical officer of AVEO. “We are very pleased to see the pace at which TIVO-3 is enrolling, and that it has completed its first safety review. We look forward to the futility analysis around midyear, and to other potential achievements in our tivozanib clinical program, including the expected first patient treated in the tivozanib and Opdivo® combination study, TiNivo, in early March.”
Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications. Tivozanib has been investigated in several tumors types, including renal cell, colorectal and breast cancers.
About the TIVO-3 Trial
The Phase 3 TIVO-3 trial is a pivotal, randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC). The trial is expected to enroll approximately 322 patients with recurrent 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. 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 regulatory approval of tivozanib in the U.S. as a first and third line treatment for RCC.