Celgene is stopping its Phase III trial of lenalidomide in patients with castrate-resistant prostate cancer (CRPC). The decision was based on the recommendation from the Data Monitoring Committee (DMC) that the study, called Mainsail, would not demonstrate a statistically significant effect against the primary endpoint of overall survival.
The compound is the active ingredient in the marketed drug Revlimid. Halting the CRPC trial means that the firm’s nearest hope for expanding its label now falls on studies in myelodysplastic syndromes (MDS), chronic lymphocytic leukemia (CLL), and non-Hodgkin lymphoma (NHL).
“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 says. The double-blinded Mainsail trial was set up to evaluate the efficacy and safety of docetaxel and prednisone with or without lenalidomide.
The compound, branded as Revlimid, is indicated in nearly 70 countries in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. In Australia and New Zealand it is also sanctioned in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy.
In the U.S., Canada, several Latin American countries, Malaysia, and Israel, Revlimid is marketed for transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Marketing applications are reportedly being evaluated in a number of other countries.
The molecule is currently under Phase III investigation as a treatment for other types of MDS, CLL, and NHL. Celgene also has a Phase II solid tumor trial that includes lenalidomide. It is reportedly in over 300 clinical trials around the globe.
Revlimid makes ups a significant portion of Celgene’s sales. In the third quarter, the drug brought in $820 million, over 67% of total sales for that quarter, which reached almost $1.22 billion. During all of 2010, Revlimid sales increased approximately 44% to approximately $2.47 billion.
For Q3 2011, Revlimid sales grew 28% from Q2 2011. This was reportedly driven by continued market share gains, increased treatment duration, and geographic expansion. U.S. sales of $467 million and international sales of $353 million increased 25% and 32%, respectively, during Q3.