Celgene Corporation (NASDAQ: CELG) today announced that after consultation with the U.S. Food and Drug Administration (FDA) Celgene 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. 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.
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. The majority of patients presented with multiple comorbidities, such as diabetes, congestive heart failure, renal impairment and elevated bilirubin count.
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.
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.
REVLIMID is approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy, in nearly 70 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.