Sanofi-aventis, Regeneron Discontinue Phase 3 Trial For Aflibercept

Sanofi-aventis and Regeneron Pharmaceuticals have discontinued the phase 3 trial that evaluated aflibercept (VEGF Trap) plus gemcitabine versus placebo plus gemcitabine, for the first-line treatment of metastatic pancreatic cancer (VANILLA), based on the recommendations by an Independent Data Monitoring Committee (IDMC).

As part of an interim efficacy analysis, the IDMC determined that the addition of aflibercept to gemcitabine would be unable to demonstrate a statistically significant improvement in the primary endpoint of overall survival, compared to placebo plus gemcitabine in this study.

Marc Cluzel, senior vice president of Research and Development at sanofi-aventis, said: “We are disappointed with the result of this study and we will continue our efforts to bring new and effective treatments for these patients. We remain committed to the other ongoing phase 3 trials of aflibercept in colorectal cancer, non-small cell lung cancer, and hormone-refractory metastatic prostate cancer.”