PRESS RELEASE ZALTRAPTM (aflibercept) Significantly Improved Survival in Previously Treated Metastatic Colorectal Cancer Patients
– Results from Pivotal Phase III VELOUR Trial to be Presented at the ESMO World Congress on Gastrointestinal Cancer –
Paris, France and Tarrytown, NY – June 6, 2011 – Sanofi (EURONEXT: SAN and NYSE:
SNY) and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced that data showing that the investigational agent ZALTRAPTM (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 ZALTRAPTM or placebo in combination with the FOLFIRI regimen
(irinotecan-5-fluorouracil-leucovorin). The addition of ZALTRAPTM 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 ZALTRAPTM 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 ZALTRAPTM 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 2.6 percent of patients in the ZALTRAPTM 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 Drug Administration and the European Medicines Agency in the second half of the year. »
« These results highlight the potential utility of our novel anti-VEGF therapy in cancer settings where there continue to be significant medical need, » said George D. Yancopoulos, M.D., Ph.D.,
Chief Scientific Officer of Regeneron and President of Regeneron Research Laboratories. « We look forward to further developing ZALTRAPTM using innovative combinations that can help advance the management of patients with cancer. »
The VELOUR study was a multinational, randomized, double-blind trial comparing FOLFIRI in combination with either ZALTRAPTM or placebo in the treatment of patients with mCRC. The study randomized 1,226 patients with mCRC who previously had been treated with an oxaliplatin-based regimen. Approximately 30 percent of patients in the trial received prior bevacizumab therapy. The primary endpoint was an improvement in overall survival. Secondary endpoints included progression-free survival, response to treatment, and safety. 1/4

Télécharger le communiqué
!:!iframe http://www.nextnews.fr/upload/fr/nextnews%5Fsanofi%5Faventis%5Fzaltrap%99%5Faflibercept%5Fsignificantly%5Fimproved%5Fsurvival%5Fin%5Fpreviously%5Ftreated%5Fmetastatic%5Fcolorectal%5Fcancer%5Fpatients%5F55776%2EPDF!:!

En partenariat avec NextNews

Tags: communiqués d'entreprises, entreprises