학술논문
Rituximab biosimilar for the treatment of diffuse large B-cell lymphoma: a phase 3 randomized study in India.
Document Type
Academic Journal
Author
Patel A; Unique Hospital Multispecialty & Research Institute, Surat, India.; Bhatt N; Kailash Cancer Hospital and Research Center, Vadodara, India.; Prakash SS; MMC and RI, K R Hospital, Mysore, India.; Biswas G; Sparsh Hospital & Critical Care (P) Ltd, Bhubaneswar, India.; Nagarkar R; HCG Manavata Cancer Centre, Nashik, Maharashtra, India.; Roy B; Netaji Subhash Chandra Bose Cancer Hospital, Kolkata, West Bengal, India.; Samal P; Institute of Medical Sciences (IMS) and SUM Hospital, Bhubaneswar, Odisha, India.; Agrawal N; Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, India.; Meshram S; Government Medical College and Hospital, Nagpur, Maharashtra, India.; Kaushal A; HCG Cancer Centre, Ahmedabad, Gujarat, India.; Satheesh CT; Healthcare Global Enterprises Limited, Bangalore, Karnataka, India.; Wategaonkar R; 7-Orange Hospital, Pune, Maharashtra, India.; Thiagarajan KV; Meenakshi Mission Hospital and Research Centre, Madurai, Tamil Nadu, India.; Jain K; Shree Himalaya Cancer Hospital & Research Institute, Vadodara, Gujarat, India.; Vijayaveeran P; Universal Cancer Hospital, Salem, Tamil Nadu, India.; Mukherjee K; Chittaranjan National Cancer Institute, Kolkata, West Bengal, India.; Singh K; Maulana Azad Medical College and Lok Nayak Hospital, Delhi, India.; Patil T; Global Hospital & Research Institute, Pune, Maharashtra, India.; Jain A; Valentis Cancer Hospital, Uttar Pradesh, Mussoorie, Meerut, India.; Dolai TK; Nil Ratan Sircar Medical College and Hospital, Kolkata, West Bengal, India.; Jain M; Grant Medical Foundation, Pune, Maharashtra, India.; Hingmire S; Deenanath Mangeshkar Hospital and Research Center, Pune, Maharashtra, India.; Gupta TC; Apex Hospital Private Limited, Jaipur, Rajasthan, India.; Lakshmaiah KC; Srinivasam Cancer Care Multispeciality Hospitals India Pvt. Ltd, Bangalore, Karnataka, India.; Rajamanickam D; Thangam Hospital and Thangam Cancer Center, Namakkal, Tamil Nadu, India.; Nemade B; Navsanjeevani Hospital, Nashik, Maharashtra, India.; Goyal V; Sanjeevani CBCC Cancer Hospital, Raipur, Chhattisgarh, India.; Mahato P; HCG Cancer Centre, Vadodara, Gujarat, India.; Mendiratta SK; Biologics (R & D and Manufacturing), Zydus Research Center, Moraiya, Ahmedabad, 382213, India. sanjeevkumar@zyduslife.com.; Doshi M; Biologics (R & D and Manufacturing), Zydus Research Center, Moraiya, Ahmedabad, 382213, India.
Source
Publisher: Springer Verlag Country of Publication: Germany NLM ID: 7806519 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1432-0843 (Electronic) Linking ISSN: 03445704 NLM ISO Abbreviation: Cancer Chemother Pharmacol Subsets: MEDLINE
Subject
Language
English
Abstract
Purpose: Very few studies have demonstrated the rituximab biosimilarity in terms of efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity in patients with diffuse large B-cell lymphoma (DLBCL) in India. Therefore, we compared the efficacy, safety, pharmacokinetic, pharmacodynamic, and immunogenicity of our biosimilar rituximab with the reference rituximab (Ristova, Roche products [India] Pvt. Ltd) in patients with DLBCL in India.
Methods: A phase 3, randomized, assessor-blind, parallel-group, two-arm study was conducted across 28 sites in India. A total of 153 newly diagnosed DLBCL patients were randomized to receive either biosimilar rituximab or reference rituximab. The study drugs were administered at a dose of 375 mg/m2 by intravenous infusion every 3 weeks for six cycles. The primary end point was objective response rate (ORR) at the end of Cycle 6. Secondary end points included: pharmacokinetic, pharmacodynamics, immunogenicity, and safety assessment.
Results: The ORR at the end of Cycle 6 was 82.14% in the biosimilar rituximab and 85.71% in the reference rituximab group. The risk difference (90% CIs) was - 3.57 (- 14.80, 7.66). It met the non-inferiority margin of - 20%. The pharmacokinetic and pharmacodynamic parameters were comparable between the two treatment groups. The incidence rate of immunogenicity was very low and similar in both the treatment groups. The safety profile of both the treatments was comparable with no major difference in terms of nature, frequency and severity of TEAEs.
Conclusion: The study demonstrated the biosimilarity between the biosimilar rituximab and the reference rituximab. Our biosimilar rituximab could add to the cost-effective treatment alternatives for patients with DLBCL in India.
(© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)
Methods: A phase 3, randomized, assessor-blind, parallel-group, two-arm study was conducted across 28 sites in India. A total of 153 newly diagnosed DLBCL patients were randomized to receive either biosimilar rituximab or reference rituximab. The study drugs were administered at a dose of 375 mg/m
Results: The ORR at the end of Cycle 6 was 82.14% in the biosimilar rituximab and 85.71% in the reference rituximab group. The risk difference (90% CIs) was - 3.57 (- 14.80, 7.66). It met the non-inferiority margin of - 20%. The pharmacokinetic and pharmacodynamic parameters were comparable between the two treatment groups. The incidence rate of immunogenicity was very low and similar in both the treatment groups. The safety profile of both the treatments was comparable with no major difference in terms of nature, frequency and severity of TEAEs.
Conclusion: The study demonstrated the biosimilarity between the biosimilar rituximab and the reference rituximab. Our biosimilar rituximab could add to the cost-effective treatment alternatives for patients with DLBCL in India.
(© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)