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Sanofi-aventis and Regeneron Report Top-line Results from Phase III Study with aflibercept (VEGF Trap) in Second-Line Non-Small Cell Lung Cancer
Date:3/10/2011

d at an upcoming medical meeting.

"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, SVP 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."

About the VITAL Phase III StudyThe VITAL study was a multinational, randomized, double-blind trial comparing aflibercept versus placebo in combination with docetaxel patients with locally advanced or metastatic non-squamous NSCLC who have failed one platinum-based therapy.  The study enrolled 913 patients who were randomized to receive intravenous (IV) docetaxel 75 mg/m2 plus either IV placebo or IV aflibercept 6 mg/kg every three weeks until disease progression, unacceptable toxicity, patient's refusal or further treatment.  The primary objective of the study was to demonstrate improvement in overall survival with the combination of aflibercept and docetaxel compared with placebo and docetaxel.

About the Aflibercept Clinical Development ProgramSanofi-aventis Oncology and Regeneron are collaborating on a broad oncology development program, combining the investigational agent aflibercept with common chemotherapy regimens in the treatment of patients with advanced cancers.  In addition to VITAL, the program includes two Phase III trials and one Phase II trial, all of which are fully enrolled:

  • VELOUR: Second-line treatment for metastatic colorectal cancer in combination with 5-fluorouracil, leucovorin and irinotecan (FOLFIRI) (Phase III).  Final results are anticipated during the first half of 2011.

  • VENICE: First-line treatment for hormone-refractory metastatic prostate cancer in
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  • SOURCE Regeneron Pharmaceuticals, Inc.
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