Positive results from Sanofi-aventis and Regeneron ZALTRAP Phase III study in mCRC

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) announced that the Phase III VELOUR trial evaluating the investigational agent ZALTRAP™ (aflibercept), also known as VEGF Trap, in combination with the FOLFIRI chemotherapy regimen [folinic acid (leucovorin), 5-fluorouracil, and irinotecan] versus a regimen of FOLFIRI plus placebo met its primary endpoint of improving overall survival (OS) in the second-line treatment of metastatic colorectal cancer (mCRC).  

The most frequent adverse events reported with ZALTRAP in combination with FOLFIRI were diarrhea, asthenia/fatigue, stomatitis and ulceration, nausea, infection, hypertension, gastrointestinal and abdominal pains, vomiting, decreased appetite, decreased weight, epistaxis, alopecia, and dysphonia.

Full results will be presented at an upcoming medical meeting.

"We are pleased with the results of the ZALTRAP Phase III study in this group of patients," said Debasish Roychowdhury, M.D., Senior Vice President and Head, Global Oncology Division, sanofi-aventis.  "We are committed to bringing ZALTRAP to patients with advanced colorectal cancer and maximizing the therapeutic potential of this unique and exciting medicine."

"These findings are exciting given the limited second-line treatment options for patients with metastatic colorectal cancer," said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Research Laboratories.  "Based upon these positive findings, we and sanofi-aventis plan to submit regulatory applications for marketing approval to the U.S. Food and Drug Administration and the European Medicines Agency in the second half of the year."