Aflibercept fails to extend survival of men with mCRPC in pivotal Phase III trial

Not entirely surprisingly, in a joint media release from Regeneron Pharmaceuticals and Sanofi issued yesterday, the two companies have announced that the investigational agent aflibercept did not extend overall survival in combination with docetaxel and prednisone in the randomized Phase III VENICE trial.

The randomized, double-blind, multi-national, Phase III VENICE study (VEGF Trap Administered with Docetaxel in metastatic androgen-independent prostate cancer) was designed to compare the efficacy and safety of aflibercept (also known as Zaltrap®) in combination with docetaxel and prednisone to a placebo + docetaxel + prednisone in men with metastatic, castration-resistant prostate cancer (mCRPC). A total of 1,224 patients with mCRPC were randomized to receive one or other of the two regimens.  The primary study endpoint was an improvement in overall survival. Secondary endpoints included effects on PSA levels, pain, and progression-free survival.

According to the media release, Regeneron and Sanofi “are conducting a detailed analysis of the VENICE data, and full results will be presented at an upcoming medical meeting.” However, it seems unlikely that any further investment will be made in aflibercept as a potential treatment for advanced forms of prostate cancer.

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