BioCentury
ARTICLE | Clinical News

Aveo RCC compound trends toward detrimental survival effect, again

November 6, 2018 11:22 PM UTC

Despite announcing plans to submit an NDA to FDA for its renal cell carcinoma compound in about six months, Aveo Pharmaceuticals Inc. (NASDAQ:AVEO) lost $0.51 (20%) to $2.03 on Tuesday after reporting preliminary data late Monday that showed no overall survival benefit for Fotivda tivozanib as a third-line treatment vs. Nexavar sorafenib in the Phase III TIVO-3 trial (HR=1.06, p=0.69). The company designed TIVO-3 to address a 2013 complete response letter for Fotivda in which FDA expressed concern about a negative OS trend seen in the first Phase III trial, TIVO-1.

Aveo said data for OS, a secondary endpoint, from TIVO-3 are not yet mature. Final survival data are expected in August 2019, which would be about three months after Aveo's planned NDA submission. The company also said it will request an end-of-Phase III meeting with FDA as early as next week to discuss the data and its submission plans...