Celgene to Offer Results of Pivotal Study Evaluating REVLIMID in Mantle-Cell Lymphoma at ASHAM

Celgene International Sàrl (NASDAQ: CELG) today announced results from the“EMERGE” study (MCL-001), a phase II, multi-center, single-arm trialevaluating REVLIMID^® (lenalidomide) in patients with previously treatedmantle cell lymphoma (MCL).In the study, 134 patients who had failed prior treatment with rituximab,cyclophosphamide, an anthracycline (or mitoxantrone), and bortezomib received25 mg of lenalidomide on days 1-21 of each 28-day cycle. The primary endpointsof the study were overall response rate and duration of response. Secondaryendpoints included complete response, progression-free survival, time toprogression, overall survival, and safety.The overall response rate in the study for lenalidomide was 28% (37/134) witha complete response rate (CR/CRu) of 8% (10/134). The median duration ofresponse was 16.6 months (95% CI, 7.7-26.7). Additionally, the medianprogression-free survival for patients in the study was 4.0 months (95% CI,3.6-5.6).The most common grade 3/4 adverse events were neutropenia (43%),thrombocytopenia (27%), anemia (11%), pneumonia (8%), fatigue (7%), leukopenia(7%) and febrile neutropenia (7%). Other adverse events included tumor flarereaction (10%), deep vein thrombosis (4%), pulmonary embolism (2%) andinvasive second primary malignancies (2%).These data are from an investigational study. REVLIMID® is not approved forthe treatment of mantle cell lymphoma.