Revlimid lenalidomide: Interim Phase III data

Celgene said it does not plan to seek approval of Revlimid as maintenance therapy of DLBCL after interim data from the double-blind, international Phase III REMARC trial in 650 DLBCL patients who responded to induction therapy with R-CHOP chemotherapy ( Rituxan rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) showed that once-daily Revlimid for 3 weeks every 4 weeks for 24 months “showed no benefit” on the secondary endpoint of OS vs. placebo. The company said Revlimid did meet the primary endpoint of improving PFS vs. placebo. The trial was sponsored by The Lymphoma Academic Research Organisation. ...