Celgene Announces Revlimid Maintenance Therapy Showed Statistical Significance Reduction, Says MEL200 Showed Longer Median PFS, OS vs MPR

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Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation
CELG
, today announced data from a study comparing melphalan, prednisone and REVLIMID (lenalidomide) (MPR) with high-dose chemotherapy and tandem autologous stem cell transplant (MEL200), as well as evaluating the effect of lenalidomide maintenance in patients with newly-diagnosed multiple myeloma were presented during a June 3^rd oral session at the American Society of Clinical Oncology (ASCO) 2013 Annual Meeting in Chicago, Ill. In the study, conducted by the Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA), and presented by lead investigator, Prof. Antonio Palumbo, Chief of the Myeloma Unit, Department of Oncology, at the University of Torino, a total of 402 patients received four 28-day courses of lenalidomide and low-dose dexamethasone at diagnosis, and then were randomly assigned to receive six cycles of MPR (n=202) or MEL200 (n=200), and to receive either continuous lenalidomide maintenance treatment or to be followed by observation. After a median follow-up of 49 months from diagnosis, median progression-free survival (PFS), the primary endpoint of the study, was 24 months with MPR compared to 38 months with MEL200 (HR 1.69, p<0.0001). ). The five-year overall survival (OS) rate was 62% (125/202) for MPR compared to 71% (142/200) for MEL200 (HR 1.25, p=0.27). In the maintenance analysis, with a median follow-up of 35 months, patients receiving lenalidomide maintenance following either regimen, had a median PFS of 37 months compared to 26 months for observation (HR 0.52, p<0.0001). In addition, for patients receiving lenalidomide maintenance, the five-year OS rate was 75% (149/198) compared to 58% (118/204) for patients being observed until disease progression (HR 0.62, p=0.02) equating to a 38% reduction in the risk of death for patients receiving continuous lenalidomide maintenance therapy. The most common grade 3/4 adverse events observed during the maintenance phase of the study were neutropenia (23%), cutaneous toxicity (5%), infections (4%), second primary malignancies (4%), thrombocytopenia (4%), diarrhea (3%), fatigue (3%) and anemia (2%). These results are from an investigational study. REVLIMID^® is not approved for the treatment of patients with newly-diagnosed multiple myeloma.
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