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

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Celgene International Sàrl (NASDAQ: CELG) today announced results from the “EMERGE” study (MCL-001), a phase II, multi-center, single-arm trial evaluating REVLIMID^® (lenalidomide) in patients with previously treated mantle cell lymphoma (MCL).

In the study, 134 patients who had failed prior treatment with rituximab, cyclophosphamide, an anthracycline (or mitoxantrone), and bortezomib received 25 mg of lenalidomide on days 1-21 of each 28-day cycle. The primary endpoints of the study were overall response rate and duration of response. Secondary endpoints included complete response, progression-free survival, time to progression, overall survival, and safety.

The overall response rate in the study for lenalidomide was 28% (37/134) with a complete response rate (CR/CRu) of 8% (10/134). The median duration of response was 16.6 months (95% CI, 7.7-26.7). Additionally, the median progression-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 flare reaction (10%), deep vein thrombosis (4%), pulmonary embolism (2%) and invasive second primary malignancies (2%).

These data are from an investigational study. REVLIMID® is not approved for the treatment of mantle cell lymphoma.

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