Sanofi-Aventis and Regeneron Pharmaceuticals have announced negative results from a Phase III trial evaluating investigational agent aflibercept (VEGF Trap) as a second-line treatment of non-small cell lung cancer.
Results from the study showed that adding aflibercept to chemotherapy drug docetaxel did not meet the pre-specified criteria for primary endpoint, which was defined as improvement in overall survival, compared to docetaxel plus placebo.
The addition of aflibercept to docetaxel demonstrated activity as measured by key secondary endpoints of the study – progression-free survival and an overall objective response rate of 23.3% in the aflibercept arm compared to 8.9% in the placebo arm.
The multinational, randomised, double-blind trial compared aflibercept plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic non-squamous non-small cell lung cancer who had failed one platinum-based therapy.
The study enrolled 913 patients who were randomised to receive either aflibercept plus docetaxel or placebo plus docetaxel.
Aflibercept is an investigational angiogenesis inhibitor, which binds angiogenic growth factors that appear to play a role in tumour angiogenesis and inflammation.