The MAGNIFY phase IIIb trial looked at the efficacy and safety of lenalidomide combined with rituximab in relapsed/refractory indolent non-Hodgkin lymphoma.
CHICAGO-Lenalidomide combined with rituximab showed activity and a tolerable safety profile in patients with relapsed/refractory indolent non-Hodgkin lymphoma, according to new results from the MAGNIFY phase IIIb trial (abstract 7513). The findings were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting, held May 31–June 4 in Chicago. The drug combination also showed activity in patients refractory to rituximab.
Lenalidomide is an immunomodulatory agent and has shown enhanced efficacy when combined with rituximab in the first-line setting, specifically in the AUGMENT trial, where the duo yielded a 39.4 month median progression-free survival (PFS) in indolent non-Hodgkin lymphoma.
The MAGNIFY trial was designed to determine the best duration of lenalidomide treatment. The study included 370 patients with follicular lymphoma grade 1-3a (80%) or marginal zone lymphoma (20%). Subjects’ median age was 66 years, and 97% were Eastern Cooperative Oncology Group (ECOG) performance score 0-1. A total of 83% had stage III/IV disease, and the median prior therapies received was 2, 97% of which contained rituximab. The patients were initially treated with 20 mg/d, d1-21/28 plus rituximab 375 mg/m2/week in the first cycle, followed by rituximab every 8 weeks in cycle 3 and beyond. After 12 cycles, patients with stable disease were randomized to continue receiving the combination or to switch to rituximab-only maintenance.
To date, 310 patients are evaluable. After a median follow-up 16.7 months, the overall response rate was 73% and the complete response rate was 45%. The median time to response was 2.7 months, the median duration of response was 36.8 months, and the median PFS was 36.0 months. ORR was 74% in follicular lymphoma, 65% in marginal zone lymphoma, 63% in rituximab-refractory patients, 78% in rituximab non-refractory patients, 51% in double refractory patients, 78% in non-double refractory patients, 68% in early relapsers, and 75% in non-early relapsers.
Adverse events included fatigue (48%), neutropenia (40%), diarrhea (35%), nausea (30%), and constipation (29%). The most common grade 3/4 adverse event was neutropenia (34%). Other grade 3/4 adverse events occurred at a frequency of less than 6%. This safety profile was consistent with previous reports.