Setback for Sanofi & Regeneron

On Friday, Sanofi-Aventis (SNY - Analyst Report) and collaboration partner, Regeneron Pharmaceuticals (REGN - Analyst Report) suffered a pipeline setback with the companies halting development of their late-stage pipeline candidate, aflibercept, for the treatment of pancreatic cancer.

Aflibercept, an anti-angiogenesis agent being developed for a variety of tumor types, was in a phase III study, which was evaluating the efficacy of the drug in combination with Eli Lilly’s (LLY - Analyst Report) Gemzar (gemcitabine) versus placebo plus Gemzar for the first-line treatment of pancreatic cancer.

A planned interim efficacy analysis of the study, carried out by an independent data monitoring committee, showed that the addition of aflibercept to Gemzar would not lead to a statistically significant improvement in the primary endpoint of overall survival compared to the placebo plus Gemzar combination. The companies will conduct a detailed analysis of the efficacy and safety data, which will be presented at a future medical meeting.

The discontinuation of the study is a major disappointment for the companies. However, the companies noted that pancreatic cancer is among the more difficult-to-treat cancers with other experimental products failing to achieve significant benefit over existing treatments.

It is estimated that more than 42,000 people are diagnosed with pancreatic cancer every year. Eli Lilly’s Gemzar is considered the standard for the first-line treatment of metastatic pancreatic cancer. 

Sanofi-Aventis and Regeneron will continue developing aflibercept for the second-line treatment of metastatic colorectal cancer, the second-line treatment of non-small cell lung cancer (NSCLC), and the first-line treatment of hormone-refractory metastatic prostate cancer. The candidate is in phase III studies for each of these indications. Regeneron’s shares fell 6.9% in after-hours trading.

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