Interim analysis of MAGNIFY phase IIIb study of Revlimid (lenalidomide) plus rituximab in marginal zone lymphoma- Celgene Corp

Celgene Corporation announced results from an interim analysis of MAGNIFY, a phase IIIb, randomized, open-label, multicenter study of Revlimid (lenalidomide) plus rituximab (R2) combination therapy in patients with relapsed or refractory marginal zone lymphoma (MZL), a form of Non-Hodgkin lymphoma that account for 8% of all NHL. Interim data were presented from an analysis of a subset of patients from the MAGNIFY study with relapsed or refractory FL (n=160) with early relapse (ER, n=52) and double-refractory (DR, n=50) disease.

At the January 9, 2017 data cut-off, the 1-year PFS for all FL patients was 70%, with 65% for DR patients and 49% for ER patients. Additionally, evaluable FL patients (n=128) had an ORR of 66% with a CR/CRu rate of 38%. For DR patients (n=42), ORR was 45% with a CR/CRu rate of 21% and for ER patients (n=43), ORR was 47% with a CR/CRu rate of 21%. Median DOR was not met at a median follow-up of 10.2 months. Most common grade 3 or 4 adverse events observed in the study for all FL patients, DR patients and ER patients, respectively, were neutropenia (29%, 42%, 37%), fatigue (6%, 4%, 8%), leukopenia (5%, 8%, 10%), thrombocytopenia (4%, 8%, 4%) and lymphopenia (3%, 6%, 4%).

The MAGNIFY study continues to evaluate the clinical activity of 12 cycles of R2 combination therapy followed by randomization to either 18 cycles of R2 maintenance or 18 cycles of rituximab monotherapy, in patients with relapsed or refractory follicular lymphoma (FL), marginal zone lymphoma (MZL) or mantle cell lymphoma (MCL). Results were presented at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland and expanded upon data presented earlier in the month at the American Society of Clinical Oncology (ASCO) meeting in Chicago, Ill.