ARTICLE | Clinical News

Revlimid lenalidomide: Updated Phase III data

December 13, 2010 8:00 AM UTC

Updated data from an open-label, Spanish Phase III trial in 57 evaluable patients showed that Revlimid plus dexamethasone produced an ORR of 75%, including 29 partial responses (PRs), 7 "very good" PRs (VGPRs), 3 complete responses (CRs) and 4 "stringent" CRs (sCRs). In 33 patients who completed 9 cycles of treatment, the ORR was 91%, including 19 PRs, 5 VGPRs, 3 CRs and 3 sCRs. After a median follow-up of 16 months, the rate of disease progression was 3% (4/118) for Revlimid vs. 18% (21/118) for patients in the therapeutic abstention arm of the trial. Median time to symptomatic myeloma was 25 months for patients receiving no treatment and has not yet been reached for Revlimid-treated patients (p<0.0001). Patients received once-daily 25 mg Revlimid on days 1-21 plus 20 mg dexamethasone on days 1-4 and 12-15 of a 28-day cycle for 9 cycles, followed by once-daily 10 mg Revlimid on days 1-21 of a 28-day cycle until progression. Data were presented at the American Society of Hematology meeting in Orlando. ...