Single-Agent Lenalidomide in Patients With Mantle-Cell Lymphoma Who Relapsed or Progressed After or Were Refractory to Bortezomib Phase II MCL-001 (EMERGE) Study

SUMMARY: In the MCL-001 trial, 134 patients with relapsed or refractory Mantle Cell Lymphoma (MCL) were enrolled. These patients had received prior treatment with RITUXAN® (Rituximab), CYTOXAN® (Cyclophosphamide), an Anthracycline and VELCADE® (Bortezomib) alone or in combination. The median age was 67 years and patients received a median of 4 prior therapies for MCL. Treatment consisted of Lenalidomide (REVLIMID®) 25 mg given orally on days 1 thru 21, of a 28 day cycle. Treatment was continued until disease progression or treatment intolerance. The primary efficacy endpoints were overall response rate (ORR) and duration of response (DOR). The secondary endpoints included Complete Response (CR), Progression Free Survival (PFS) and Overall Survival (OS). The ORR was 28% with a CR of 7% and the median DOR for those who responded to REVLIMID® was 16.6 months. The median PFS was 4 months and the median OS was 19 months.The most common grade 3-4 adverse reactions were cytopenias, fatigue, dyspnea and diarrhea. The authors concluded that REVLIMID® is the first drug to receive approval for the treatment of MCL since VELCADE® was approved for this disease in 2006 and gives one additional option for MCL patients, refractory to VELCADE®. Goy A, Sinha R, Williams ME, Besisik SK et al. J Clin Oncol 2013;31:3688-3695