Sanofi-aventis (SNY) and Regeneron Pharmaceuticals, Inc. (REGN) revealed the discontinuation of the Phase 3 trial evaluating aflibercept plus gemcitabine versus placebo plus gemcitabine in the first-line treatment of metastatic pancreatic cancer. The move was based on the recommendations of an Independent Data Monitoring Committee.
The companies said that the monitoring committee's decision to discontinue the Phase 3 trial based on a part of planned interim efficacy analysis. The company 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 the clinical study. The types and frequencies of adverse events reported on the combination arm with aflibercept were generally as anticipated.
Further, the companies would analyze in detail the efficacy and safety results, which later will be presented at a future medical meeting. Patients in the study will continue to be provided access to aflibercept at the determination of the study investigators in consultation with the patients.
Commenting on the discontinuation of the clinical trial, senior vice president, research and development at sanofi-aventis, Marc Cluzel 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."
Metastatic pancreatic cancer is among the most intractable cancers. Clinical development of new therapies, including anti-VEGF agents, has been generally characterized by a failure to achieve significant incremental clinical benefit over existing treatments.
SNY closed Friday's regular trading session at $35.05, up $0.13 or 0.37% on a volume of 2.27 million shares.
REGN closed Friday's regular trading at $21.88, down $0.11 or 0.50% on a volume of 649,805 shares. Further, the stock lost $1.73 or 7.91%, and traded at $20.15 in the after hours.
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