BioCentury
ARTICLE | Clinical News

FDA reviewers take issue with Amgen's T-Vec trial

April 28, 2015 1:23 AM UTC

FDA reviewers questioned "both the existence and the magnitude of an overall benefit" of talimogene laherparepvec from Amgen Inc. (NASDAQ:AMGN) in BioVex Inc. began the Phase III trial in 2009; Amgen acquired the company in 2011.

In the trial, talimogene met the primary endpoint of showing a higher durable response rate vs. GM-CSF (15.6% vs. 1.4%; p<0.0001), but not the secondary endpoint of overall survival (23.3 months vs. 18.9 months, p=0.051). ...