Celltrion Healthcare Releases Multinational Real-World Data on 'Truxima'

Celltrion's targeted anticancer biosimilar 'Truxima' (Photo by Celltrion Healthcare)

[Asia Economy Reporter Chunhee Lee] Real-world data (RWD) from a multinational, multicenter study on non-Hodgkin lymphoma (NHL) patients treated with the targeted anticancer biosimilar drug Truxima (generic name rituximab), developed by Celltrion and sold overseas by Celltrion Healthcare, has been released.

According to Celltrion Healthcare on the 22nd, a paper titled "Real Clinical Effectiveness and Safety of CT-P10 in Patients with Diffuse Large B-Cell Lymphoma (DLBCL): An Observational Study in Five Major European Countries (EU5)" was published in the academic journal eJHaem, issued by the British Society for Haematology. The study analyzed medical records of 389 DLBCL patients treated with Truxima at 24 medical institutions across five major European countries. CT-P10 is the development code name for Truxima.

The research team led by Professor Pier L. Zinzani from the IRCCS University Hospital of Bologna and Ser?gnoli Institute of Hematology in Italy set overall survival (OS), progression-free survival (PFS), and best response (BR) as the primary endpoints to confirm clinical effectiveness. They evaluated these indicators by dividing the follow-up periods into 12, 18, and 30 months from the first administration of Truxima.

The results showed survival rates of 86% at 12 months, 81% at 18 months, and 76% at 30 months. Progression-free survival rates were 78%, 72%, and 67% respectively for each period. Regarding the BR indicator, complete response (CR) was 82%, partial response (PR) 12%, stable disease (SD) 4%, and progression 2%. In terms of adverse events (AE), 90% of patients experienced at least one AE, but most were consistent with side effects related to anticancer treatment.

This data showed similar clinical effectiveness results to previously published RWD studies from Korea and the Netherlands. The research team explained, "Until now, clinical data on Truxima for DLBCL patient treatment was limited. This study is significant as it is the first to confirm multinational, multicenter RWD for Truxima, showing results similar to those from single-country studies." They also noted that since this study provides real-world data on the effectiveness and safety of Truxima for DLBCL, it will support the adoption of Truxima as a treatment option for DLBCL patients.

Celltrion Healthcare plans to use this DLBCL RWD to expand Truxima prescriptions in Europe. In particular, from the second half of this year, Truxima is being directly sold (direct sales) in Europe through a self-established distribution infrastructure. Based on this, it is expected that market share will expand through competitive bidding supported by flexible pricing strategies. Celltrion Healthcare anticipates that the study results will enhance local medical professionals' prescription preferences for Truxima, and they plan to aggressively promote the drug to key stakeholders to create marketing synergy with direct sales and drive prescription growth.

A Celltrion Healthcare official stated, "DLBCL corresponds to indication extrapolation for rituximab, so data on treatment efficacy was limited. However, with the release of this RWD, the first multinational, multicenter study data for Truxima has been secured, drawing significant interest from the local medical community." The official added, "Since DLBCL is a high-risk disease where drug selection and switching are carefully considered during treatment, we will actively utilize this data to ensure that Truxima reaches as many patients as possible."

This content was produced with the assistance of AI translation services.