Objective: This randomized, double-blind, phase 3 study evaluated the efficacy, safety, and immunogenicity of biosimilar rituximab (DRL_RI) versus rituximab (MabThera®) in patients with low-tumor-burden follicular lymphoma (LTB-FL).

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 8 weekly from Week 12 to Week 36 (maintenance treatment) and followed up till Week 52. The primary endpoint was best overall response rate (BORR) up to Week 28 based on blinded independent central review. Efficacy equivalence was demonstrated if the two-sided 90% CI for BORR difference was within the prespecified equivalence margin (±17%). Secondary endpoints included objective and complete responses, duration of response, progression-free survival, overall survival, safety, immunogenicity and exploratory endpoints included mean serum drug concentrations, and pharmacodynamics (PD).

Results: The BORR up to Week 28 was 80.2% vs. 79.4% for DRL_RI vs. MabThera® group; with a difference of 0.89% [90% CI: -6.67-8.48; 95% CI: -8.05-9.93 within the prespecified margin]. Both treatment groups were comparable for all secondary efficacy endpoints. Treatment-emergent adverse events were reported in 68.6% of patients; safety, immunogenicity, and mean serum drug concentrations were similar between groups. Peripheral B-cell counts declined below quantifiable limits in most patients, with a median time to B-cell depletion of 6.9 days vs. 7.0 days for DRL_RI vs. MabThera®.

Conclusion: The study demonstrated efficacy equivalence of DRL_RI to MabThera®; with comparable safety, immunogenicity, serum drug concentrations, and PD between groups.

Clinical Trial Registry Information: This trial was registered at ClinicalTrials.gov identifier: NCT03976102 and EudraCT (2018-004223-36).

Disclosures

Maharaj:Dr.Reddy's Laboratories Ltd: Current Employment. Uppada:Dr.Reddy's Laboratories Ltd: Current Employment. Eswaraiah:Dr.Reddy's Laboratories Ltd: Current Employment. Kakkattu:Dr.Reddy's Laboratories Ltd: Current Employment. Reddy:Dr.Reddy's Laboratories Ltd: Current Employment. Belada:Takeda: Consultancy, Research Funding; Hoffmann-La Roche: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Swixx: Consultancy; Pharmacyclis: Research Funding; Astra Zenecca: Research Funding; Regeneron: Research Funding; Gilead Sciences: Consultancy; AbbVie: Consultancy; Swixx BioPharma: Consultancy; Genmab: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Consultancy; Eli Lilly: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; MorphoSys: Research Funding. Oliveira:Janssen-Cilag, S.A.: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Abbvie: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Beigene: Consultancy, Speakers Bureau; Alexion: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Roche: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; AstraZeneca: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Takeda: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Kim:Roche: Other: All authors received support for third-party writing assistance, furnished by Akshaya Srinivasan, PhD, CMPP, of Nucleus Global, an Inizio company, and funded by F. Hoffmann-La Roche Ltd, Basel, Switzerland..

This content is only available as a PDF.
2024
Sign in via your Institution