Phase II Multicenter Study of Single-Agent Lenalidomide in Subjects with Mantle Cell Lymphoma Who Relapsed or Progressed After or Were Refractory to Bortezomib The MCL-001 “EMERGE” Study

SUMMARY: Mantle cell lymphomas constitute approximately 5% of all Non Hodgkins lymphomas and have a high relapse rate following dose-intensive therapies. Bortezomib (VELCADE®) is approved for the treatment of relapsed mantle cell myeloma (MCL) and has a response rate of 30%. This open label, phase II trial, evaluated the safety and efficacy of Lenalidomide (REVLIMID®) in 134 patients with MCL who have had prior therapy with Rituximab (RITUXAN®), Cyclophosphamide, Anthracycline and had relapsed or progressed in less than 12 months or were refractory to VELCADE®. Patients had a median of 4 prior treatments. Treatment consisted of single agent REVLIMID® 25 mg/day given on days 1 thru 21 of a 28-day cycle, given until disease progression or unacceptable toxicity. The primary endpoints were overall response rate (ORR) and duration of response. The secondary endpoints included complete response (CR), Progression Free Survival (PFS), time to progression, overall survival (OS) and safety. In this heavily pretreated patient population the ORR was 28% and the median duration of response of 16.6 months. The CR was 8%, PFS was 4.0 months, and OS was 19.0 months. The most common grade 3/4 adverse events were cytopenias. The authors concluded that REVLIMID® resulted in rapid and durable responses in patients with relapsed/refractory MCL. Goy A, Sinha R, Williams ME, et al. 54th ASH Annual Meeting and Exposition 2012, Abstract 905