Journal of Clinical Oncology publishes Phase III results of ZALTRAP® (aflibercept) VELOUR study

Sanofi (EURONEXT: SAN and NYSE: SNY) today announced that detailed results from the pivotal Phase III VELOUR study evaluating ZALTRAP® (aflibercept) Injection for Intravenous Infusion for the treatment of patients with previously treated metastatic colorectal cancer were published in the October 2012 edition of the Journal of Clinical Oncology (JCO).

ZALTRAP is a recombinant fusion protein that binds to Vascular Endothelial Growth Factor (VEGF)- A, VEGF-B, and placental growth factor (PlGF). In the VELOUR trial evaluating metastatic colorectal cancer patients previously treated with an oxaliplatin-containing regimen, ZALTRAP in combination with the FOLFIRI chemotherapy regimen (5-fluorouracil, leucovorin, irinotecan) showed a statistically significant improvement in overall survival, progression-free survival, and the overall tumor response rate versus placebo plus FOLFIRI.

“We want to express our appreciation to the authors and the editorial board of the JCO for publishing the results of the VELOUR trial,” said Debasish Roychowdhury, M.D., Senior Vice President and Head of Sanofi Oncology. “The scrutiny of the FDA review and peer review processes should provide physicians confidence in the results of VELOUR, as they make important decisions for their patients.”

The VELOUR data supported the regulatory approval of ZALTRAP by the U.S. Food and Drug Administration (FDA) on August 3, 2012 after a Priority Review. In the US, ZALTRAP is approved with the US proper name ziv-aflibercept for use in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI) for patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen. ZALTRAP is under review at the European Medicines Agency and other regulatory agencies worldwide.

About the VELOUR Phase III Study

The VELOUR trial showed that in patients previously treated with an oxaliplatin-containing regimen, adding ZALTRAP to FOLFIRI significantly improved median survival from 12.06 months to 13.50 months (HR=0.817 (95% CI 0.714 to 0.935; p=0.0032), an 18 percent relative risk reduction. A significant improvement in progression-free survival from 4.67 months to 6.90 months (HR=0.758 95% CI 0.661 to 0.869; p=0.00007), a 24 percent relative risk reduction, was also observed. The overall response rate in the ZALTRAP plus FOLFIRI arm was 19.8% vs. 11.1% for FOLFIRI (p=0.0001).

The most common adverse reactions (all grades, >20% incidence) reported at a higher incidence (2% or greater between-arm difference) in the ZALTRAP-FOLFIRI arm, in order of decreasing frequency, were leucopenia, diarrhea, neutropenia, proteinuria, AST increased, stomatitis, fatigue, thrombocytopenia, ALT increased, hypertension, weight decreased, decreased appetite, epistaxis, abdominal pain, dysphonia, serum creatinine increased, and headache. The most common Grade 3-4 adverse reactions (>5%) reported at a higher incidence (2% or greater between-arm difference) in the ZALTRAP-FOLFIRI arm, in order of decreasing frequency, were neutropenia, diarrhea, hypertension, leucopenia, stomatitis, fatigue, proteinuria, and asthenia.

The Phase III VELOUR study was a multinational, randomized, double-blind trial comparing FOLFIRI in combination with either ZALTRAP or placebo in the treatment of patients with metastatic colorectal cancer (mCRC). The study randomized 1,226 patients with mCRC who previously had been treated with an oxaliplatin-containing regimen. The primary endpoint was an improvement in overall survival. Secondary endpoints included progression-free survival, overall response rate, and safety.

About ZALTRAP® (aflibercept)

ZALTRAP is a recombinant fusion protein that acts as a soluble receptor that binds to Vascular Endothelial Growth Factor-A (VEGF-A), VEGF-B and placental growth factor (PIGF). Under the terms of their collaboration agreement, Sanofi and Regeneron share equally the global profits of ZALTRAP after Regeneron’s obligation to repay its share of development expenses. In the U.S., ZALTRAP is a registered trademark of Regeneron Pharmaceuticals, Inc.

About Colorectal Cancer

Worldwide, colorectal cancer is the third most commonly diagnosed cancer in males and the second most in females, with more than 1.2 million new cases diagnosed in 2008. One of the deadliest cancers, colorectal cancer was responsible for more than 600,000 deaths globally in 2008 alone.

According to the American Cancer Society, it is estimated that more than 143,000 new cases of colorectal cancer will be diagnosed in 2012, and more than 51,000 people will die from it in the US. Approximately 60 percent of colorectal cancer cases are diagnosed at the locally advanced or metastatic stage. Although survival for early stage disease is relatively high, once colorectal cancer metastasizes to distant organs, five-year survival is estimated to be 12 percent.

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