Analysis of Japanese patients from the AUGMENT phase III study of lenalidomide + rituximab (R2) vs. rituximab + placebo in relapsed/refractory indolent non-Hodgkin lymphoma

Patients with indolent non-Hodgkin lymphoma (iNHL) typically respond to first-line immunochemotherapy, but relapse is common. Treatment options for relapsed iNHL include chemotherapy ± rituximab and rituximab monotherapy. Lenalidomide plus rituximab ( R 2 ) is an immunomodulatory regimen that enhances rituximab-mediated cytotoxicity and improves clinical activity in iNHL. AUGMENT was a double-blind phase III randomized trial of R 2 vs. rituximab + placebo (R-placebo) in patients with relapsed/refractory follicular lymphoma or marginal zone lymphoma who were not refractory to rituximab. The primary endpoint was progression-free survival (PFS). Data reported here focus on Japanese patients from AUGMENT and reflect 36 patients ( n = 18, each group). PFS was superior in the R 2 group, HR = 0.32 (95% CI 0.11–0.96). Median PFS was not reached (95% CI 19.7–NE) in the R 2 group vs. 16.5 months (95% CI 11.3–30.6) in the R-placebo group. Grade 3/4 adverse events were more frequent in patients treated with R 2 (67%) than with R-placebo (22%), primarily attributable to increased neutropenia (50% vs 17%). R 2 resulted in significantly longer median PFS than R-placebo in Japanese patients with R/R iNHL, and the efficacy and the safety profile of R 2 were similar to those reported in the global population.