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Sanofi, Regeneron lung cancer drug fails to meet primary endpoint

Sanofi-aventis and Regeneron Pharmaceuticals have announced results from the Phase III trial evaluating the investigational agent aflibercept (VEGF Trap) as a second-line treatment of non-small cell lung cancer (NSCLC).

The study results showed that adding aflibercept to the 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 (PFS) and an overall objective response rate (ORR) 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 NSCLC who have failed one platinum-based therapy.

The study enrolled 913 patients who were randomised to receive either aflibercept plus docetaxel or placebo plus docetaxel.

Aflibercept (VEGF Trap) is an investigational angiogenesis inhibitor, which binds angiogenic growth factors that appear to play a role in tumour angiogenesis and inflammation.