Journal Article

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

Kobayashi Tsutomu, Kiguchi Toru, Ishikawa Takayuki, Kalambakas Stacey, Tobinai Kensei, Fustier Pierre, Fukuhara Noriko, Izutsu Koji, Minami Yosuke, Nagai Hirokazu, Ohtsu Tomoko, Midorikawa Shuichi, Terui Yasuhito, Jo Tatsuro, Yamamoto Go

2020

Overview

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 (R2) 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 R2 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, eacy group). PFS was superior in the R2 group, HR = 0.32 (95% CI 0.11–0.96). Median PFS was not reached (95% CI 19.7–NE) in the R2 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 R2 (67%) than with R-placebo (22%), primarily attributable to increased neutropenia (50% vs 17%). R2 resulted in significantly longer median PFS than R-placebo in Japanese patients with R/R iNHL, and the efficacy and the safety profile of R2 were similar to those reported in the global population.

• Publisher: Springer Nature B.V
• Subject: Chemotherapy / Clinical trials / Cytotoxicity / Immunomodulation / Immunomodulators / Immunotherapy / Lymphoma / Monoclonal antibodies / Neutropenia / Non-Hodgkin's lymphoma / Patients / Rituximab / Targeted cancer therapy / Toxicity