Sanofi-aventis, Regeneron's aflibercept fails to meet goal of late-stage lung cancer study

Sanofi-aventis and partner Regeneron Pharmaceuticals announced that data from a late-stage study demonstrated that the addition of aflibercept to Taxotere (docetaxel) as a second-line treatment for patients with non-small-cell lung cancer did not improve overall survival compared with Taxotere alone.

The VITAL trial randomised 913 patients with locally-advanced or metastatic non-squamous NSCLC who had failed one platinum-based therapy to receive Taxotere plus either aflibercept or placebo. Top-line data indicated that aflibercept failed to meet the study's main goal of improving overall survival, although the companies noted that the drug demonstrated activity in several secondary endpoints, including showing a progression-free survival benefit. The addition of aflibercept to chemotherapy also led to an overall objective response rate of 23.3 percent, compared to 8.9 percent for chemotherapy alone.

Sanofi-aventis' head of oncology, Debasish Roychowdhury noted that the drug is also being evaluated in late-stage trials as a treatment for metastatic colorectal cancer and hormone-refractory metastatic prostate cancer, with results expected in the first half of this year and in 2012, respectively.

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