AVEO Flat on Futility Analysis

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) weakened mid-morning Friday, after the company reported completion of TIVO -3 study futility analysis with no changes to protocol.
The Cambridge, Mass.-company announced Thusrday in a news release announced results of th trial, the Company’s randomized, controlled, multi-center, open-label study to compare FOTIVDA® (tivozanib) to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC).
The release went on to say that, based on the results of the futility analysis, which was reviewed by an independent statistician, the study will continue as planned without modification.
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.
AVEO CEO Michael Bailey said in the same release, “The treatment of advanced renal cell cancer is undergoing rapid change, with immunotherapy and combination regimens delivering improved outcomes for patients and shaping a new treatment paradigm.
“We believe our tivozanib clinical strategy positions us well in this evolving landscape, with the TIVO-3 study on track to provide the first post-immunotherapy pivotal datasets for a VEGF-TKI, and the TiNivo study providing early and encouraging combination data.
The Company is focused on seeking to develop and commercialize its lead candidate tivozanib, a potent, selective, long half-life inhibitor of vascular endothelial growth factor 1, 2 and 3 receptors, in North America as a treatment for renal cell carcinoma and other cancers.
Shares in AVEO inched back a dime, or 2.5%, Friday, to $3.85