Sanofi-Aventis and Regeneron's Zaltrap improves OS in Ph III colon cancer study

French drug major Sanofi-Aventis (Euronext: SAN) and USA-based partner Regeneron Pharmaceuticals (Nasdaq: REGN) have 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 news, released on Tuesday, pushed Regeneron’s shares 7.4% higher to $56 at close of trading that day.

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, senior vice president and head, Global Oncology Division, at Sanofi-Aventis, adding: "We are committed to bringing Zaltrap A to patients with advanced colorectal cancer and maximizing the therapeutic potential of this unique and exciting medicine."