Sanofi-Aventis and Regeneron have announced that advanced ovarian cancer patients with recurrent symptomatic malignant ascites (SMA) receiving aflibercept (VEGF Trap) in a randomized, placebo-controlled Phase 2 study, experienced a statistically significant improvement.
Mean time to first repeat paracentesis following a baseline procedure was 55 days with aflibercept as compared to 23 days for patients receiving placebo (p=0.0019).
George Yancopoulos, President of Regeneron, said: The results of this Phase 2, placebo-controlled study demonstrate that aflibercept is a clinically active agent in patients with advanced ovarian cancer with symptomatic malignant ascites. However, given the small number of patients enrolled in this study and the fragile health status of these advanced ovarian cancer patients, who had a median survival of only about three to four months, it is difficult to definitively assess the overall clinical benefit that might be derived from treatment in the real-world clinical practice setting.”
“Therefore, we and sanofi-aventis have decided not to submit these Phase 2 data for approval in symptomatic malignant ascites. We will focus our efforts on completing the current Phase 3 program which combines aflibercept with standard chemotherapy regimens for the treatment of earlier stage metastatic colorectal, non-small cell lung, pancreatic, and prostate cancers, which should begin delivering data in 2010.”