Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Nov 6;4(1):45-54.
doi: 10.1002/jha2.593. eCollection 2023 Feb.

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

Mark J Bishton  1   2 , Gilles Salles  3 , Camille Golfier  3 , Wolfgang Knauf  4 , Monica Bocchia  5 , Deborah Turner  6 , Borhane Slama  7 , Jatinder Harchowal  8 , Scott Marshall  9 , Alberto Bosi  10 , Juan José Bargay Lleonart  11 , Manfred Welslau  12 , SooKyoung Kim  13 , Young N Lee  13 , Pier L Zinzani  14   15 , Kamel Laribi  16
Affiliations

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

Mark J Bishton et al. EJHaem. .

Abstract

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.

Keywords: DLBCL; NHL; biosimilar; rituximab.

PubMed Disclaimer

Conflict of interest statement

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.

Figures

FIGURE 1
FIGURE 1
Kaplan–Meier charts for overall survival and progression‐free survival from index (months) for patients where CT‐P10 was the first line of treatment at index. Overall survival (OS) for all patients from index (A). Progression‐free survival (PFS) for all patients from index (B). OS for patients taking CT‐P10 as a first‐line of treatment (C). PFS for patients taking CT‐P10 as a first‐line of treatment (D). The assessment of disease progression was based on what was documented in patient medical records. This included the ‘Revized Response Criteria for Malignant Lymphoma’ [21] (if these criteria were used and documented locally).
FIGURE 2
FIGURE 2
Overall and best response to CT‐P10. First response to CT‐P10 recorded on or after 3‐ and 6‐months postindex for all patients (A). Best response to CT‐P10 during the observation period for all patients (B). First response to CT‐P10 recorded on or after 3‐ and 6‐month postindex for patients receiving CT‐P10 as a first‐line treatment (C). Best response to CT‐P10 during the observation period for patients receiving CT‐P10 as a first‐line treatment (D)
See this image and copyright information in PMC

References

    1. Celltrion Healthcare . Truxima 500 mg concentrate for solution for infusion: EU summary of product characteristics. Union register of medicinal products. Available from: https://ec.europa.eu/health/documents/community‐register/html/h1167.htm. Accessed 31 Mar 2021.
    1. truxima . Highlights of prescribing informatio. Available from: https://www.truxima.com/globalassets/truxima‐dtc/pdfs/truxima‐prescribin.... Accessed 15 Jun 2021.
    1. European Medicines Agency . Truxima. Amsterdam, Netherlands European Medicines Agency; 2018.. https://www.ema.europa.eu/en/medicines/human/EPAR/truxima
    1. Roche Products Ltd . Mabthera 100mg and 500mg concentrate for solution for infusion: summary of product characteristics. 2017. Available from: https://www.medicines.org.uk/emc/medicine/2570. Accessed 22 Jan 2018.
    1. rituxan . NHL & CLL 90 minute infusion | RITUXAN® (rituximab). rituxan. Available from: https://www.rituxan‐hcp.com/nhl‐cll/dosing‐and‐administration/rituxan‐ad.... Accessed 16 Feb 2021.