Phase 2 study of aflibercept for the treatment of advanced ovarian cancer with ascites

Sanofi-aventis and Regeneron Pharmaceuticals announced data from a Phase 2 trial for their fusion protein product, aflibercept (VEGF Trap), in the treatment of advanced ovarian cancer patients with recurrent symptomatic malignant ascites (SMA).  This trial was a double-blind, placebo-controlled, multi-center study demonstrating a statistically significant improvement in the primary study endpoint, mean time to first repeat paracentesis (removal of fluid from the abdominal cavity), versus placebo control.  The patients in this trial had failed a prior platinum-based chemotherapy regimen and had also received chemotherapy treatment with either liposomal doxorubicin or topotecan.  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).

Aflibercept is an antiangiogenesis inhibitor that binds all forms of Vascular Endothelial Growth Factor-A (VEGF-A), VEGF-B, and placental growth factor (PIGF), another angiogenic growth factor that appears to play a role in tumor angiogenesis and inflammation. Aflibercept has been shown to bind these grown factors with a higher affinity than their natural receptors.

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