Rituximab biosimilar for the treatment of diffuse large B-cell lymphoma: a phase 3 randomized study in India

Area of Science:

• Oncology
• Pharmacology
• Clinical Trials

Background:

• Limited studies exist on rituximab biosimilarity in Indian diffuse large B-cell lymphoma (DLBCL) patients.
• Establishing biosimilarity is crucial for expanding treatment options.

Purpose of the Study:

• To compare the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of a biosimilar rituximab against reference rituximab in Indian DLBCL patients.
• To evaluate the non-inferiority of the biosimilar rituximab.

Main Methods:

• A Phase 3, randomized, assessor-blind, parallel-group study conducted at 28 Indian sites.
• 153 newly diagnosed DLBCL patients received either biosimilar or reference rituximab (375 mg/m² every 3 weeks for 6 cycles).
• Primary endpoint: Objective Response Rate (ORR) at Cycle 6. Secondary endpoints: PK, PD, immunogenicity, and safety.

Main Results:

• Objective Response Rate (ORR) was 82.14% for biosimilar rituximab and 85.71% for reference rituximab, meeting non-inferiority criteria.
• Comparable pharmacokinetic and pharmacodynamic profiles were observed between the groups.
• Low and similar incidence of immunogenicity and comparable safety profiles (TEAEs) were noted for both treatments.

Conclusions:

• The study demonstrates biosimilarity between the biosimilar rituximab and the reference product.
• The biosimilar rituximab presents a cost-effective treatment alternative for DLBCL patients in India.