On the 15th November 2019, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of lenalidomide in combination with rituximab (R²) for the treatment of adult patients with relapsed/refractory (R/R) grade 1-3a follicular lymphoma (FL).1 R2 is a chemotherapy-free treatment regimen consisting of immunomodulating lenalidomide plus the anti-CD20 antibody rituximab. The combination was approved earlier this year by the U.S. Food and Drug Administration (FDA) for the treatment of patients with marginal zone lymphoma (MZL) and FL (read more here).
The positive opinion was based on the data from the multicentre phase III studies AUGMENT (NCT01938001) and MAGNIFY (NCT01996865). AUGMENT investigated the efficacy and safety of R2 in comparison with rituximab alone in 295 patients with R/R FL. The study reported improved median progression-free survival (PFS) with the R2 combination compared to the rituximab alone (39.4 months vs 14.1 months, respectively), a hazard ratio of 0.46, and the objective response rate (ORR) of 80% in patients with FL.2 Meanwhile, the MAGNIFY study explored the efficacy of R2 followed by maintenance with lenalidomide or rituximab in 370 patients with R/R FL, MZL, or mantle cell lymphoma.3 In patients with FL, the ORR was 74% and the median PFS was 30.2 months. Read the Lymphoma Hub’s coverage of the AUGMENT study and watch Mathias Rummel discussing the MAGNIFY trial.