PARIS and TARRYTOWN, N.Y., June 6, 2011 /PRNewswire/ — Sanofi
(EURONEXT: SAN and NYSE:
SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ:
REGN) today announced that data showing that the
investigational agent ZALTRAP™ (aflibercept), also known as
VEGF Trap, significantly improved survival in previously treated
metastatic colorectal cancer patients will be presented at the ESMO
World Congress on Gastrointestinal Cancer on June 25, 2011.
The abstract (#0-0024) was published in the June 2011
supplement to Annals of Oncology.
Patients with metastatic colorectal cancer (mCRC) previously
treated with oxaliplatin were randomized to receive ZALTRAP or
placebo in combination with the FOLFIRI regimen
(irinotecan-5-fluorouracil-leucovorin). The addition of
ZALTRAP to the FOLFIRI regimen significantly improved both overall
survival (HR=0.817; p=0.0032) and progression-free survival
(HR=0.758; p=0.00007). A similar effect was seen with ZALTRAP
therapy whether or not patients had received prior bevacizumab
therapy.
Grade 3 or 4 adverse events (AEs) that occurred with a more than
2 percent greater incidence in the ZALTRAP arm than in the placebo
arm included diarrhea, asthenia/fatigue, stomatitis/ulceration,
infections, hypertension, GI/abdominal pains, neutropenia,
neutropenic complications and proteinuria. Deaths on study
treatment due to AEs occurred in 2.4 percent of patients in the
ZALTRAP arm and in 1.0 percent of patients in the placebo arm.
“We are excited by these results and are committed to
bringing this novel therapy to patients as soon as possible,”
said Debasish Roychowdhury, M.D., Senior Vice President and
Head, Sanofi Oncology. “We plan to submit
regulatory applications for marketing approval to the U.S. Food and
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