Sanofi-Aventis and partner Regeneron Pharmaceuticals have presented top-line data showing that colorectal cancer candidate Zaltrap has come through a late-stage study successfully.
The partners announced that the 1,226-patient Phase III VELOUR trial evaluating Zaltrap (aflibercept), also known as VEGF Trap, in combination with the FOLFIRI chemotherapy regimen versus FOLFIRI plus placebo met its primary endpoint of improving overall survival in the second-line treatment of metastatic colorectal cancer (mCRC). Full results will be presented at an upcoming medical meeting.
George Yancopoulos, chief scientific officer at Regeneron, said "these findings are exciting given the limited second-line treatment options for patients with mCRC”. He added that based on the results, regulatory marketing applications will be made to the US Food and Drug Administration and the European Medicines Agency in the second half of the year.
The positive data is a boost for Sanofi and Regeneron, given that last month aflibercept failed in a late-stage trial for non-small cell lung cancer. Studies have also been stopped that were evaluating the drug in metastatic pancreatic cancer and ovarian cancer in the past 18 months or so.
However, a Phase III trial combining Zaltrap with docetaxel and prednisone as first-line treatment for hormone-refractory metastatic prostate cancer in combination with docetaxel and prednisone is ongoing. An interim analysis is expected to be conducted in mid-2011 and final results are due 2012.
Outside of oncology, Regeneron is developing aflibercept with Bayer as a treatment of central vein occlusion in the eye. On the basis of positive results in two Phase III studies, marketing submissions for VEGF Trap-Eye are planned shortly in Europe and the USA.