Real-world outcomes of diffuse large B-cell lymphoma in the biosimilar era

Frontiers in Oncology

Oncology

Chitra Lele¹  Manju Sengar²  Narendra Maharaj³  Pramod Reddy³  Suresh Kankanwadi⁴  Reena Nair⁵  Pankaj Malhotra⁶  Narendra Agrawal⁷  Soniya Nityanand⁸  Gull Mohammad Bhat⁹ 

[1] ActuReal Services and Consulting Private Limited, Pune, Maharashtra, India;Adult Hematolymphoid Disease Management Group, Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India;Biologics, Dr. Reddy’s Laboratories Ltd, Bachupally, Hyderabad, India;Biologics, Ex-Dr. Reddy’s Laboratories Ltd, Bachupally, Hyderabad, India;Department of Clinical Haematology, Tata Medical Centre, Kolkata, West Bengal, India;Department of Clinical Hematology & Medical Oncology, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India;Department of Hemato-Oncology & Bone Marrow Transplant, Rajiv Gandhi Cancer Institute and Research Center, Delhi, India;Department of Hemotology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India;Department of Medical Oncology, Sher-I-Kashmir Institute of Medical Sciences, Srinagar, Jammu & Kashmir, India;

关键词: rituximab;    real world;    DLBCL;    biosimilar;    Reditux™;    Ristova Rituximab;    Ristova;   

DOI  :  10.3389/fonc.2023.1248723

 received in 2023-06-27, accepted in 2023-09-11,  发布年份 2023

来源: Frontiers

【 摘 要 】

BackgroundDiffuse large B-cell lymphoma (DLBCL) is an aggressive and the most common type of non-Hodgkin lymphoma (NHL). The clinical use of rituximab has improved the treatment response and survival of patients with DLBCL. The introduction of rituximab biosimilar into healthcare system has helped in providing a cost-effective treatment to B-cell lymphoid malignancies as standard of care and has improved access to patients worldwide. The aim of this study was to observe the real-world effectiveness and safety of Reditux™ and Ristova® in DLBCL patients.MethodsObservational study in adults with DLBCL receiving Reditux™ or Ristova® across 29 centers in India (2015–2022). Effectiveness and safety were assessed up to 2 years after first dose.ResultsOut of 1,365 patients considered for analysis, 1,250 (91.6%) were treated with Reditux™ and 115 (8.42%) with Ristova®. At 2 years, progression-free survival (PFS) 69% [hazard ratio (HR), 1.16; 95% CI, 0.80–1.67], overall survival (OS) 78.7% (HR, 1.20; 95% CI, 0.78–1.86), response rates, quality of life (QoL), and overall safety in both the cohorts were comparable. The best overall response rate (BORR) at 6 months was comparable with no statistically significant differences between the Reditux™ and the Ristova® cohorts (89.2% vs. 94.3%). In multivariate analysis, BCL-2 and VAS were significant prognostic factors for PFS.ConclusionReditux™ and Ristova® were comparable in real-world setting.Clinical Trial RegistrationISRCTN registry, identifier (ISRCTN13301166)

【 授权许可】

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Copyright © 2023 Nair, Bhat, Agrawal, Sengar, Malhotra, Nityanand, Lele, Reddy, Kankanwadi and Maharaj