Celgene announced that after consulting the FDA it will discontinue treatment with Revlimid (lenalidomide) in the open-label Phase 3 ORIGIN trial. An imbalance was observed in the number of deaths in patients treated with lenalidomide vs. patients treated with chlorambucil.
The ORIGIN study was designed to evaluate the safety and efficacy of lenalidomide vs. 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 on July 12, 2013, with the discontinuation of lenalidomide treatment. No specific causality for this imbalance has been identified to date.
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. All other Celgene-sponsored chronic lymphocytic leukemia clinical trials with lenalidomide are continuing in accordance with their respective protocols.
Revlimid is already approved for transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality. It is also approved in combination with dexamethasone for treatment of patients with multiple myeloma (MM) who have received at least one prior therapy and for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
For more information visit www.celgene.com.