Revlimid lenalidomide: Phase III discontinued

Celgene discontinued the open-label, international Phase III ORIGIN (CLL-008) trial in 450 elderly patients with previously untreated B cell CLL after an imbalance in the number of deaths was observed in patients treated with Revlimid compared to chlorambucil. Specifically, there were 34 deaths out of 210 patients in the Revlimid arm compared to 18 deaths out of 211 patients in the chlorambucil arm. Celgene said no specific causality for the imbalance has been identified to date. FDA had placed the trial, which enrolled B cell CLL patients with co-morbidities that precluded treatment with more aggressive standard chemo-immunotherapies, on clinical hold on July 12. Celgene said all other company-sponsored CLL trials of Revlimid are continuing in accordance with their respective protocols. ...