Celgene to drop Revlimid in CR prostate cancer following Ph III trial failure

There was disappointment for blockbuster for multiple myeloma drug Revlimid (lenalidomide) when the Swiss subsidiary of US biotech firm Celgene (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).

The company said 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,” Celgene said.

Revlimid is approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in nearly 70 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.