Celgene To Discontinue Treatment With Revlimid In Phase III ORIGIN Trial

(RTTNews) - Celgene Corp. (CELG) announced that, after consultation with the U.S. Food and Drug Administration or FDA, it will discontinue treatment with Revlimid (lenalidomide) in the open-label, phase III ORIGIN trial, which enrolled 450 patients in over 100 sites in 26 countries.

The company said that an imbalance was observed in the number of deaths in patients treated with lenalidomide versus patients treated with chlorambucil.

The FDA placed the ORIGIN study on clinical hold on July 12, 2013, with the discontinuation of lenalidomide treatment. All clinical investigators in ongoing chronic lymphocytic leukemia studies using lenalidomide will be officially advised of this action and instructed to inform their patients accordingly, the company said.

Revlimid is not approved as a treatment for patients with chronic lymphocytic leukemia.

The ORIGIN study was designed to evaluate the efficacy and safety of lenalidomide versus chlorambucil as single agent in elderly patients = 65 years of age with B-cell chronic lymphocytic leukemia and with comorbidities that precluded treatment with more aggressive standard chemo-immunotherapies, including fludarabine and bendamustine containing regimens.

Based on an imbalance in deaths, specifically 34 deaths out of 210 patients in the lenalidomide arm compared to 18 deaths out of 211 patients in the chlorambucil arm, FDA placed the study on clinical hold. No specific causality for this imbalance has been identified to date, the company noted.

Results from the CLL-008 study will be presented at an upcoming medical conference.

All other Celgene-sponsored chronic lymphocytic leukemia clinical trials with lenalidomide are continuing in accordance with their respective protocols.