French drug giant Sanofi S.A. (SNY) on Monday said the detailed positive results from the pivotal Phase III VELOUR study evaluating ZALTRAP (aflibercept) Injection for Intravenous Infusion for patients with previously treated metastatic colorectal cancer were published in the October 2012 edition of the Journal of Clinical Oncology or JCO.
The company said the latest data supported the regulatory approval of ZALTRAP by the U.S. Food and Drug Administration on August 3 after a Priority Review.
ZALTRAP is a recombinant fusion protein that binds to Vascular Endothelial Growth Factor or VEGF- A, VEGF-B, and placental growth factor. Sanofi and Regeneron Pharmaceuticals, Inc. (REGN) share equally the global profits of ZALTRAP.
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 previously treated with an oxaliplatin-containing regimen.
Sanofi noted that ZALTRAP in combination with the FOLFIRI chemotherapy regimen in the trial showed a statistically significant improvement in overall survival as the primary endpoint, while secondary endpoints included progression-free survival, the overall tumor response rate versus placebo plus FOLFIRI, and safety.
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, an 18 percent relative risk reduction.
The company also observed a significant improvement in progression-free survival from 4.67 months to 6.90 months, a 24 percent relative risk reduction. The overall response rate in the ZALTRAP plus FOLFIRI arm was 19.8 percent vs. 11.1 percent for FOLFIRI, the company noted.
The drug is approved in the U.S. with the US proper name ziv-aflibercept for use in combination with FOLFIRI for patients with metastatic colorectal cancer 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.
Debasish Roychowdhury, Senior Vice President and Head of Sanofi Oncology, said, "We want to express our appreciation to the authors and the editorial board of the JCO for publishing the results of the VELOUR trial. 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."
Sanofi shares closed Friday's regular trading session at $44.64, up $0.41 or 0.93 percent.
by RTT Staff Writer
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