Sanofi-aventis and Regeneron Pharmaceuticals, Inc. have updated the clinical development program for aflibercept, and provided results from a Phase II study in advanced ovarian cancer. The companies reported that a recent study did not achieve its primary endpoint of demonstrating that patients in either arm of the study achieved a RECIST (Response Evaluation Criteria in Solid Tumors) response rate that was statistically significant.
The two companies are now enrolling approximately 4,000 patients in the U.S., Europe, and other countries, in four Phase III studies that combine aflibercept with standard chemotherapy regimens. The studies include: second-line treatment for metastatic colorectal cancer in combination with folinic acid, 5-FU, and irinotecan; first-line treatment for metastatic pancreatic cancer in combination with gemcitabine; first-line treatment for metastatic androgen-independent prostate cancer in combination with docetaxel and prednisone; and second-line treatment for metastatic non-small cell lung cancer in combination with docetaxel. A Phase II first-line study of aflibercept in metastatic colorectal cancer in combination with folinic acid, 5-FU, and oxaliplatin is expected to begin later this year.
“We and sanofi-aventis are continuing to evaluate the data from this trial in order to determine the next steps for aflibercept in advanced ovarian cancer,” commented George D. Yancopoulos, M.D., Ph.D., president of Regeneron Research Laboratories.