AVEO Pharmaceuticals, Inc. (AVEO) Successfully Completes Pre-Planned Futility Analysis of FOTIVDA; Shares Soar 8%


AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) announced the successful completion of  a pre-planned futility analysis of the Phase 3 TIVO-3 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). Based on the results of the futility analysis, which was reviewed by an independent statistician, the study will continue as planned without modification.

This analysis did not allow for early stopping due to efficacy to assure adequate follow-up for the key secondary endpoint of overall survival. The pre-planned futility analysis was triggered by the reporting of 128 progression events in early August. Additional events were recorded as part of the data management process leading into the futility analysis, resulting in a revised data cut-off date for the analysis of May 29. The Company continues to expect the TIVO-3 to read out 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 a first and third line treatment for RCC.

AVEO CEO Michael Bailey commented, “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. We look forward to readout of the TIVO-3 trial in the first quarter of 2018. We also look forward to presenting Phase 1 results from the Phase 1/2 TiNivo study of tivozanib in combination with OPDIVO® at a medical conference this fall, and to leveraging tivozanib’s unique safety and efficacy profile in future potential therapy combinations.”

AVEO shares reacted to the news, rising nearly 8% to $4.26 (a new 52-week high) in after-hours trading Thursday.

On the ratings front, AVEO stock has been the subject of a number of recent research reports. In a report issued on August 28, Piper Jaffray analyst Edward Tenthoff reiterated a Buy rating on AVEO, with a price target of $4.50, which represents a potential upside of 14% from where the stock is currently trading. On June 30, FBR’s Vernon Bernardino reiterated a Buy rating on the stock and has a price target of $3.00.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Edward Tenthoff and Vernon Bernardino have a yearly average return of 11.4% and 8.6% respectively. Tenthoff has a success rate of 50% and is ranked #477 out of 4699 analysts, while Bernardino has a success rate of 34% and is ranked #817.

AVEO operates as a biopharmaceutical company, which engages in the advancement of therapeutics for oncology and other areas of unmet medical need. Its products include Tivozanib, Ficlatuzmab, AV-203, AV-380, and AV-353. It focuses on the development of its lead candidate, Tivozanib, in North America as a treatment for renal cell carcinoma and other cancers.