Celgene stops CLL trial in elderly patients due to deaths

Celgene Corp. (NASDAQ:CELG) discontinued the open-label Phase III ORIGIN (CLL-008) trial in 450 elderly patients with previously untreated B cell chronic lymphocytic leukemia (CLL) after an imbalance in the number of deaths was observed in patients treated with Revlimid lenalidomide compared to chlorambucil. There were 34 deaths out of 210 patients in the Revlimid arm compared to 18 deaths out of 211 patients in the chlorambucil arm. FDA had placed the trial, which enrolled patients with co-morbidities that precluded treatment with more aggressive standard chemo-immunotherapies, on clinical hold on July 12.

Celgene markets Revlimid in nearly 70 countries, including the U.S. and EU countries, in combination with dexamethasone to treat relapsed or refractory multiple myeloma (MM) in patients who have received one or more prior therapy. The thalidomide analog also is approved in the U.S. and EU to treat patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) with a 5q chromosomal deletion and in the U.S. for relapsed or refractory mantle cell lymphoma (MCL). ...