Real-world clinical effectiveness and safety of CT-P10 in patients with diffuse large B-cell lymphoma: An observational study in Europe.

Autor: Bishton MJ; Nottingham City Hospital Nottingham University Hospitals NHS Trust Nottingham UK.; Translational Medical Sciences University of Nottingham Nottingham UK., Salles G; Centre Hospitalier Lyon Sud - Service d'Hématologie Clinique Lyon France., Golfier C; Centre Hospitalier Lyon Sud - Service d'Hématologie Clinique Lyon France., Knauf W; Centrum Für Hämatologie und Onkologie Bethanien Frankfurt am Main Germany., Bocchia M; Hematology Unit Azienda Ospedaliero Universitaria Senese, University of Siena Siena Italy., Turner D; Torbay and South Devon NHS Foundation Trust Devon UK., Slama B; Centre Hospitalier d'Avignon Avignon France., Harchowal J; University College London Hospitals NHS Foundation Trust London UK., Marshall S; South Tyneside and Sunderland NHS Foundation Trust Sunderland Royal Hospital Sunderland UK., Bosi A; Department of Clinical and Experimental Medicine University of Florence Florence Italy., Lleonart JJB; Son Llatzer University Hospital- Institut Investigació Sanitaria Illes Balear (IdIsBa) Palma de Mallorca Spain., Welslau M; Onkologie Aschaffenburg, Klinikum Aschaffenburg Aschaffenburg Germany., Kim S; Celltrion Healthcare Co. Ltd. Incheon Republic of Korea., Lee YN; Celltrion Healthcare Co. Ltd. Incheon Republic of Korea., Zinzani PL; IRCCS Azienda Ospedaliero-Universitaria di Bologna Istituto di Ematologia 'Seràgnoli' Bologna Italy.; Dipartimento di Medicina Specialistica e Sperimentale Università di Bologna Bologna Italy., Laribi K; Department of Hematology Centre Hospitalier du Mans Le Mans France.
Jazyk: angličtina
Zdroj: EJHaem [EJHaem] 2022 Nov 06; Vol. 4 (1), pp. 45-54. Date of Electronic Publication: 2022 Nov 06 (Print Publication: 2023).
DOI: 10.1002/jha2.593
Abstrakt: The rituximab biosimilar CT-P10 is approved for the treatment of non-Hodgkin lymphoma. Previous studies have demonstrated clinical similarity between CT-P10 and reference rituximab. However, real-world data relating to treatment in patients with DLBCL with rituximab biosimilars are limited. This study collected real-world data relating to the effectiveness and safety of CT-P10 treatment from the medical records of 389 patients with DLBCL (24 centers, five European countries). For the primary outcome (clinical effectiveness), overall survival (OS), progression-free survival (PFS), and best response (BR) were assessed. The percentage (95% confidence interval [95% CI]) of patients alive at 12-, 18-, and 30 months postindex (initiation of CT-P10) was 86% (82.4%-89.4%), 81% (76.9%-84.9%), and 76% (71.2%-80.1%), respectively. The PFS rate (percent, [95% CI]) at 12-, 18-, and 30 months postindex was 78% (74.2%-82.5%), 72% (67.9%-76.9%), and 67% (61.9%-71.7%), respectively. Median OS/PFS was not reached. For 82% ( n = 312) of patients, the BR to CT-P10 was a complete response. Adverse events were consistent with known effects of chemotherapy. This international, multicenter study provides real-world data on the safety and effectiveness profile of CT-P10 for DLBCL treatment and supports the adoption of CT-P10 for the treatment of DLBCL.
Competing Interests: MB has received research funding from Takeda, Gilead, Roche, Abbvie; Travel/acc/expenses = Roche, Takeda, Gilead, Celltrion, Honararia Tevapharma, Roche, Celltrion; Advisory board = Beigene; Trial Management Group = Roche. GS has received in the last 12 months financial compensations for participating in advisory boards or consulting from: Abbvie, Bayer, Beigene, BMS/Celgene, Epizyme, Genentech/Roche, Genmab, Incyte, Janssen, Kite/Gilead, Loxo, Milteniy, Morphosys, Novartis, Rapt, Regeneron and Takeda. Shareholder: Owkin. PLZ has received personal fees for consulting from Verastem, EUSA Pharma, MSD and Novartis; personal fees for participating in a speaker's bureau from Verastem, Celltrion, Gilead, Janssen‐Cilag, BMS, Servier, MSG, TG Therapeutics, Takeda, Roche, EUSA Pharma, Kyowa Kirin, Novartis, Incyte and Beigene; and personal fees for participating in advisory boards from Verastem, Celltrion, Gilead, Janssen‐Cilag, BMS, Servier, Sandoz, MSG, TG Therapeutics, Takeda, Roche, EUSA Pharma, Kyowa Kirin, Novartis, ADC Therapeutics, Incyte and Beigene. SM has received educational grants to attend educational meetings, educational lecturing and attendance of pharmaceutical advisory boards for Novartis, Abbvie and AstraZeneca in the last year. KL has received research grants from Celltrion. Outside this work, KL has received research grants from AbbVie, Novartis, Takeda, Roche, Amgen, and Sandoz as well as personal fees from AbbVie, Novartis, Sandoz, Celgene, Jansen, and Amgen. SKK and YNL are employees of Celltrion Healthcare. CG, WK, MBo, DT, BS, JH, AB, JJB, and MW have no conflict of interest to disclose.
(© 2022 The Authors. eJHaem published by British Society for Haematology and John Wiley & Sons Ltd.)
Databáze: MEDLINE
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