Aveo's Tivozanib Under CHMP Spotlight If Negative OS Trend Continues In TIVO-3

04 Apr 2019

• By John Davis

An August 2019 analysis of overall survival in the TIVO-3 study of Aveo’s tivozanib in advanced renal cell carcinoma is now an interim rather than a final analysis, but EU regulators may take action if a negative overall survival trend is found to be continuing.

GreenPawn — Improved survival is a key measure for regulators and patients alike. • Source: Shutterstock

EU regulators have indicated they may take regulatory action if a negative overall survival (OS) trend is confirmed during the second interim analysis of Aveo Pharmaceuticals Inc.’s ongoing TIVO-3 study of its VEGFR tyrosine kinase inhibitor, tivozanib, in heavily pre-treated advanced or metastatic renal cell carcinoma, planned for August 2019.

The possibility of EU regulatory action is noted by Aveo in an SEC filing for a proposed $25m public offering...