Celgene terminates MAILSAIL trial for lack of effectiveness

According to a media release issued by Celgene yesterday, the company has terminated the so-called MAINSAIL trial in the treatment of men with castration-resistant prostate cancer (CRPC).

The MAINSAIL trial was a multi-center, randomized, double-blind, placebo-controlled study designed to compare docetaxel + prednisone + lenalidomide (Revlimid) to docetaxel + prednisone + placebo in men with CRPC. It had enrolled more than 1,000 patients.

The company’s media release states that:

A review by a data monitoring committee suggested that the triple-combination therapy would not demonstrate a statistically significant treatment effect against the primary endpoint of overall survival versus standard therapy.

Clearly it is disappointing to see a major drug that has proven efficacy in the management of other forms of cancer fail in the management of advanced forms of prostate cancer.

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