Celgene to discontinue docetaxel and prednisone plus lenalidomide Phase III trial on CRPC

Nov 23 2011

Celgene International Sàrl, a subsidiary of Celgene Corporation, (NASDAQ: CELG) announced that based on the recommendation from the Data Monitoring Committee (DMC) it will discontinue its pivotal double-blinded Phase III MAINSAIL® trial that was designed to evaluate the efficacy and safety of docetaxel and prednisone with or without lenalidomide in patients with castrate-resistant prostate cancer (CRPC).

It was determined that the combination of docetaxel and prednisone plus lenalidomide would not demonstrate a statistically significant treatment effect against the primary endpoint of overall survival versus docetaxel and prednisone plus placebo. We have accepted this recommendation of the DMC and following formal notification and review of the analysis, physicians and patients, internationally, will be officially advised of this action.

REVLIMID is not approved as a treatment for patients with prostate cancer.