Sanofi-aventis and Regeneron Report Positive Phase III Results With ZALTRAP in Second-line Metastatic Colorectal Cancer

Sanofi-aventis and Regeneron Report Positive Phase III Results With ZALTRAPTM (aflibercept) in Second-line Metastatic Colorectal Cancer

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced that the Phase III VELOUR trial evaluating the investigational agent ZALTRAPTM (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."

About the VELOUR Phase III Study

The VELOUR study was a multinational, randomized, double-blind trial comparing FOLFIRI in combination with either ZALTRAP or placebo in the treatment of patients with mCRC after failure of an oxaliplatin-based regimen.  The study enrolled 1,226 patients with mCRC who previously had been treated with an oxaliplatin-based regimen. The primary endpoint was an improvement in overall survival.  The study had 90 percent power to detect a 20 percent reduction in the hazard rate for overall survival using a two-sided log-rank test.  Secondary endpoints included progression-free survival, response to treatment, and safety.

About ZALTRAPTM (aflibercept) and its Clinical Development Program

ZALTRAP, also known as VEGF Trap, is an investigational angiogenesis inhibitor with a unique mechanism of action.  This fusion protein binds all forms of Vascular Endothelial Growth Factor-A (VEGF-A), as well as VEGF-B and placental growth factor (PIGF), additional angiogenic growth factors that appear to play a role in tumor angiogenesis and inflammation.  ZALTRAP has been shown to bind VEGF-A, VEGF-B, and PlGF with higher affinity than their native receptors.

Sanofi-aventis Oncology and Regeneron are collaborating on a broad oncology development program, combining the investigational agent ZALTRAP with common chemotherapy regimens in the treatment of patients with advanced cancers.  In addition to VELOUR, the program includes one Phase III trial and one Phase II trial, both of which are fully enrolled: