Celgene has called a halt to a late-stage trial of its oncology blockbuster Revlimid as a potential treatment for prostate cancer.
The company says that based on the recommendation from a data monitoring committee, it will discontinue the Phase III MAINSAI trial. The latter was designed to evaluate the efficacy and safety of docetaxel and prednisone with or without Revlimid (lenalidomide) in patients with castrate-resistant prostate cancer.
The DMC said it felt the docetaxel/prednisone/lenalidomide combination would not demonstrate a statistically significant treatment effect against the primary endpoint of overall survival versus docetaxel and prednisone plus placebo. Celgene said that "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 approved in combination with dexamethasone for the treatment of patients with multiple myeloma in nearly 70 countries,and in some territories for transfusion-dependent anaemia associated with myelodysplastic syndromes.
The drug is a very big earner for Celgene and third-quarter sales increased 28% to $820 million. For the full year, Revlimid revenues are forecast to reach $3,20-$3,25 billion.