Celltrion Healthcare presents the first real-world data for Truxima® (biosimilar rituximab) in patients with diffuse large B-cell lymphoma at the EHA 2021 Virtual Congress

Celltrion Healthcare presents the first real-world data for Truxima^® (biosimilar rituximab) in patients with diffuse large B-cell lymphoma at the EHA 2021 Virtual Congress

• The multi-country retrospective post-approval study is the first to investigate the safety and effectiveness of Truxima^® (biosimilar rituximab, CT-P10) in patients with diffuse large B-cell lymphoma (DLBCL) in a real-world setting.

UNDER EMBARGO FOR 17:45 CEST, SATURDAY 12 JUNE - INCHEON, SOUTH KOREA - Celltrion Healthcare today presented new data from its post-approval study evaluating the real-world clinical effectiveness and safety of Truxima® (biosimilar rituximab, CT-P10) in patients with diffuse large B-cell lymphoma (DLBCL) at the European Hematology Association (EHA) 2021 Virtual Congress.¹

CT-P10 was granted European Medicines Agency approval in 2017 for the treatment of rheumatoid arthritis (RA) and specific blood cancers, including non-Hodgkin’s lymphoma (NHL).² DLBCL is the most common subtype of NHL, representing an estimated 30-40% of adult cases.^3,4,5,6

This non-interventional post-authorisation safety study (PASS) involved the collection of patient-level data from hospital medical records for patients with DLBCL who received CT-P10 treatment in five European countries (United Kingdom, Spain, France, Germany and Italy). CT-P10 treatment pattern data were collected retrospectively during the 30-month observation period and patients were selected based on the treatment they received as part of their standard clinical care in a real-world setting. 

The primary endpoints were overall survival (OS), progression free survival (PFS) and summary of best responses and secondary endpoints included safety profile and CT-P10 treatment pathways. At 30-months post-index, amongst patients taking first-line CT-P10, 67% (95% confidence interval [CI] 61.3–72.1) had not experienced disease progression, with 74% (95% CI 69.2–79.1) overall survival. Of the 382 patients observed, over three quarters initiated on CT-P10 achieved complete or partial response by 30 months, with 82% having recorded a complete response (n=312). Partial response was seen in 12% (n=46), no response or stable disease in 4% (n=16) and progressive disease in 2% (n=8).

CT-P10 also appeared to be generally well tolerated by patients, with adverse events (AEs) consistent with those reported for reference rituximab. Overall, 90% (n=351) of patients reported at least one AE (total AEs n=2,504); 65% (n=253) experienced a grade 3 or higher AE, and 28% (n=109) were recorded as definitely, probably, or possibly related to CT-P10.

“This is the first multi-country retrospective post-approval study to investigate the effectiveness and safety of CT-P10 treatment in patients with DLBCL in a real-world setting across Europe,” said Dr. Mark Bishton, Consultant Haematologist and Honorary Clinical Associate Professor at the University of Nottingham, School of Medicine. “Over three quarters of patients initiated on CT-P10 achieved complete or partial response by 30 months. The response rates, survival rates and overall safety profile for CT-P10 appears consistent with those reported for reference rituximab, which could support the use of CT-P10 in combination with chemotherapy as a therapeutic option for DLBCL.”

Celltrion Healthcare also presented real-world data on rapid infusion of CT-P10 in patients with non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukaemia (CLL) at the EHA Updates-in-Hematology.⁷ The study was the first multi-country study to investigate the safety and effectiveness of rapid infusion of CT-P10 in a real-world setting. Safety results suggest that rapid infusion of CT-P10 was generally well tolerated, with only 10% (n=20; 95% CI: 6 – 15%) of patients experiencing an infusion-related reaction (IRR).  The majority of IRRs were grade 1 or 2 (96%), with the most common IRR being fatigue (35% n=7/20 of the patients with index IRRs), followed by nausea (30% n=6/20) and vomiting (15% n=3/20). In terms of response, the majority of patients achieved a complete response (74% n=142/192) or partial response (22% n=42/192) over the 6-month observation period.

“The recommended protocol for rituximab infusion in Europe is a slow initial infusion rate with a gradual upward titration. Rapid infusion is often used in subsequent infusions for patients who had no serious complications related to the first infusion,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “We are encouraged by the results of the study as Truxima has demonstrated a similar IRR rate to reference rituximab. This will allow informed, evidence-based decisions on cost-effective treatment strategy for patients with CLL or NHL.”