Real‐world clinical effectiveness and safety of CT‐P10 in patients with diffuse large B‐cell lymphoma: An observational study in Europe. Issue 1 (6th November 2022)

• Record Type: Journal Article
• Authors: Bishton, Mark J.; Salles, Gilles; Golfier, Camille; Knauf, Wolfgang; Bocchia, Monica; Turner, Deborah; Slama, Borhane; Harchowal, Jatinder; Marshall, Scott; Bosi, Alberto; Lleonart, Juan José Bargay; Welslau, Manfred; Kim, SooKyoung; Lee, Young N.; Zinzani, Pier L.; Laribi, Kamel
• Is Part Of: EJHaem. Volume 4:Issue 1(2023)
• Page Start: 45
• Page End: 54
• Publication Date: 2022-11-06
• Subjects: biosimilar -- DLBCL -- NHL -- rituximab; Hematology -- Periodicals; 616.15
• DOI: 10.1002/jha2.593
• Languages: English
• ISSNs: 2688-6146

Abstract

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.