Compare Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in LTB Follicular Lymphoma

Summary

The primary objective of the current study is to demonstrate the equivalent efficacy of rituximab (DRL\_RI) and MabThera® in subjects with Low Tumor Burden Follicular Lymphoma (LTB-FL). Also evaluated by Pharmacokinetic, safety, and immunogenicity assessment between a proposed biosimilar (DRL\_RI) and the RMP, as an component of clinical study program, and collectively providing the evidence of biosimilarity. The study will compare the safety and efficacy of DRL\_RI vs MabThera in patients with Low Tumor Burden Follicular Lymphoma (LTB-FL). The primary objective is to establish comparative efficacy as measured by ORR up to week 28

Timeline

Start

2019-05-15

Primary completion

2022-09-28

Completion

2023-02-27

Outcome

Met primary endpoint

paper difference of 0.89% (90% CI: -6.67 to 8.48; 95% CI: -8.05 to 9.93 within the prespecified margin). PMID 40421128 ↗

paper The study demonstrated efficacy equivalence of DRL_RI to MabThera PMID 40421128 ↗

Publications

• Maharaj N, Uppada DR, Eswaraiah A, Kakkattu R, Reddy P, Kalenik VA, Belada D, Ramos AO, Kim JS, Baranau YV. Efficacy and safety of rituximab biosimilar (DRL_RI) versus MabThera(R) in low-tumor-burden follicular lymphoma: the FLINTER study. Ther Adv Med Oncol. 2025 May 24;17:17588359251339925. doi: 10.1177/17588359251339925. eCollection 2025.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DRL_RI	Unknown	375 mg/m2	Intravenous

Indications