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CC BY-NC-ND 4.0 · Indian J Med Paediatr Oncol 2018; 39(03): 316-320
DOI: 10.4103/ijmpo.ijmpo_25_17
Original Article

A Randomized, Multiple-Dose, Multicenter, Comparative Parallel Study to Evaluate the Safety and Efficacy of Intravenous Infusion of Rituximab (Hetero) and Reference Medicinal Product (Rituximab, Roche) in Indian Patients of Non-Hodgkin's Lymphoma (HERILY)

Suresh Advani
Department of Medical Oncology, Jaslok Hospital and Research Centre, Mumbai, Maharashtra, India
,
Ghanashyam Biswas
Sparsh Hospitals and Critical Care Pvt. Ltd., Bhubaneswar, Orissa, India
,
Shubhadeep Sinha
Hetero Labs Limited-Corporate, Hyderabad, Telangana, India
,
Neetu Naidu Rayala
Hetero Labs Limited-Corporate, Hyderabad, Telangana, India
,
Sreenivasa Chary
Hetero Labs Limited-Corporate, Hyderabad, Telangana, India
,
Pankaj Thakur
Hetero Labs Limited-Corporate, Hyderabad, Telangana, India
,
Anushrita,
Santanu Tripathi
Department of Clinical and Experimental Pharmacology, School of Topical Medicine, Kolkata, West Bengal, India
,
Vamsi Krishna Bandi
Hetero Labs Limited-Corporate, Hyderabad, Telangana, India
› Author Affiliations Financial support and sponsorship Nil.
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Abstract

Objective: To compare the antitumor efficacy, safety, and pharmacodynamic (PD) characteristics of Hetero-rituximab (test) with reference medicinal product (rituximab, Roche) in non-Hodgkin's lymphoma. Patients and Methods: One hundred and thirty-five patients with diffuse large B-cell lymphoma (DLBCL) were randomized to receive intravenous infusion of either test or reference product. Efficacy (best overall response [BOR] rate [primary end point]), safety, PD (CD19), and immunological assessments (secondary end points) were done at the end of cycle 3 and cycle 6. Results:: At the end of 6 cycles, BOR rate was 73.47% in Hetero-rituximab test arm compared to the 69.09% in reference arm. Anti-rituximab antibodies were found to be negative at cycle 3 and cycle 6 for all patients. Patients treated with Hetero-rituximab show a significant depletion in CD19+ cell which was comparable with reference drug. Safety and immunogenic potential of the test drug was comparable to the reference drug in the patients of DLBCL. Conclusion: BOR rate at cycle 3, cycle 6, and end of the study lies within the prespecified limit for noninferiority which concludes that test product is therapeutically noninferior to reference medicinal product.

Keywords

Diffuse large B-cell lymphoma - non-Hodgkin's lymphoma - rituximab


Publication History

Article published online:
17 June 2021

© 2018. Indian Society of Medical and Paediatric Oncology. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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