Sanofi, Regeneron Lung Cancer Trial Misses Endpoint

Sanofi-aventis and Regeneron Pharmaceuticals’ Phase III VITAL trial evaluating the investigational drug aflibercept (VEGF Trap) for the second-line treatment of non-small cell lung cancer (NSCLC) showed that adding aflibercept to the chemotherapy drug docetaxel did not meet the primary endpoint of improvement in overall survival compared with docetaxel plus placebo. The addition of aflibercept to docetaxel demonstrated activity in 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 adverse events (AEs) on the aflibercept arm were 10% greater than the control arm and included stomatitis, weight loss, hypertension, epistaxis and dysphonia. AEs leading to treatment discontinuation occurred in 27.2% of patients in the aflibercept arm compared to 14.6% in the placebo arm.

“Bringing new and innovative cancer therapies to patients can be incredibly challenging, especially in difficult-to-treat cancers such as second-line non-small cell lung cancer,” said Debasish Roychowdhury, senior vice president and head of Global Oncology Division, Sanofi-aventis. “Our Phase III trials of aflibercept in metastatic colorectal cancer and hormone-refractory metastatic prostate cancer are underway to determine the clinical potential of aflibercept for patients with these advanced cancers.”