March 10, 2011

Sanofi-aventis and Regeneron Report Top-line Results from Phase III Study with aflibercept (VEGF Trap) in Second-Line Non-Small Cell Lung Cancer

 

Sanofi-aventis and Regeneron Report Top-line Results from Phase III Study with aflibercept (VEGF Trap) in Second-Line Non-Small Cell Lung Cancer

Paris, France and Tarrytown, NY – March 10, 2011 – Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced results from the Phase III VITAL trial evaluating the investigational agent aflibercept (VEGF Trap) for the second-line treatment of non-small cell lung cancer (NSCLC). The data showed that adding aflibercept to the chemotherapy drug docetaxel did not meet the pre-specified criteria for the primary endpoint of improvement in overall survival compared with a regimen of docetaxel plus placebo (HR=1.01, CI: 0.868 to 1.174). The addition of aflibercept to docetaxel demonstrated activity as measured by key secondary endpoints of the study: progression free survival (PFS) (HR=0.82, CI: 0.716 to 0.937) and an overall objective response rate (ORR) of 23.3 percent in the aflibercept arm compared to 8.9 percent in the placebo arm.