Efficacy and safety of rituximab biosimilar (DRL_RI) versus MabThera^® in low-tumor-burden follicular lymphoma: the FLINTER study.

ABSTRACT:

Background and objectives

This phase III study (RI-01-006; FLINTER) was conducted to demonstrate equivalent efficacy of DRL_RI to EU-approved rituximab (MabThera^®) in patients with previously untreated Stage II-IV, CD20-positive, low-tumor-burden follicular lymphoma (LTB-FL). This study also evaluated safety, immunogenicity, rituximab concentrations, and pharmacodynamics (PD) of DRL_RI compared with MabThera.

Design and methods

Previously untreated, stage II-IV, CD20-positive LTB-FL patients (N = 317) were randomized (1:1) to receive DRL_RI (n = 162) or MabThera (n = 155) as intravenous infusions of 375 mg/m² weekly for 4 weeks (induction period), and thereafter every 8 weeks from Week 12 to Week 36 (maintenance treatment), and followed up til

SUBMITTER: Maharaj N 

PROVIDER: S-EPMC12104602 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature