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

March 10, 2011 - Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) 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% in the aflibercept arm compared to 8.9 percent in the placebo arm.


The treatment emergent adverse events (AEs) on the aflibercept arm with an incidence that was 10 percent greater than the control arm were stomatitis, weight decrease, hypertension, epistaxis and dysphonia. Grade 3 or 4 AEs that occurred at a frequency of at least 5 percent in patients who received aflibercept were fatigue, stomatitis, disease progression, hypertension, febrile neutropenia, dyspnea, neutropenia, and asthenia. AEs leading to treatment discontinuation occurred in 27.2 percent of patients in the aflibercept arm compared to 14.6 percent in the placebo arm. The types and frequencies of AEs reported in the aflibercept treatment arm were generally consistent with those reported in previous studies with anti-VEGF agents... [PDF] Sanofi-aventis' Press Release - Regeneron Pharmaceuticals' Press Release -

Merrimack Pharmaceuticals : Enrollment in a Phase 1/2 Combination Study of MM-121 and Tarceva® in Patients with Non-Small Cell Lung Cancer

February 22, 2010 – Merrimack Pharmaceuticals, Inc. announced that the first patient has received an initial dose in a Phase 1/2 clinical study combining MM-121 with Tarceva® (erlotinib) in patients with nonsmall cell lung cancer (NSCLC). This is the first of multiple trials that Merrimack and sanofi-aventis expect to initiate in 2010 as part of a broad Phase 2 clinical development program for MM-121.

MM-121, Merrimack’s lead oncology therapeutic candidate, is an antibody designed to block signaling of ErbB3. Erlotinib is a small molecule targeting the epidermal growth factor receptor (EGFR).
“Our Network Biology analysis of cancer cells indicates that tumors often become resistant to EGFR-targeted therapies by compensating for tumor growth restriction through the ErbB3 receptor,"... [PDF] Merrimack Pharmaceuticals' Press Release -

UCB and sanofi-aventis, FDA Approves XYZAL® (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies

February 19, 2008 - UCB and sanofi-aventis announced that the U.S. Food and Drug Administration (FDA) approved a New Drug Application (NDA) for XYZAL® (levocetirizine dihydrochloride) 0.5 mg/mL oral solution, a prescription antihistamine indicated for the relief of symptoms associated with indoor and outdoor allergies, as well as the treatment of chronic idiopathic urticaria. XYZAL® tablets received FDA approval on May 25, 2007 and both formulations are now approved for use in adults and children 6 years and older...Many people suffer from the symptoms associated with common allergic conditions. The immune system of allergy sufferers over-reacts to something in the environment, leading to symptoms that affect their respiratory system, eyes, or skin. Estimates from the American Academy of Allergy, Asthma & Immunology (AAAAI) suggest that indoor and outdoor allergies affect as many as 40 million people in the United States... UCB's press Release- [PDF] sanofi-aventis' Press release-