Celltrion Reports Positive Real-World Findings for Truxima in DLBCL

Celltrion Healthcare reported positive findings from a European Union real-world safety and efficacy study comparing the company’s rituximab biosimilar (CT-P10, Truxima) with the reference product (Rituxan) in patients with diffuse large B-cell lymphoma (DLBCL), the most common subtype of non-Hodgkin lymphoma (NHL). Results were reported at the European Hematology Association 2021 Virtual Congress.

Celltrion also released real-world data demonstrating comparable safety and effectiveness of CT-P10 rapid infusion.

CT-P10 treatment data were collected during a 30-month observation period. Primary end points included overall survival (OS) and progression-free survival (PFS), and secondary end points included safety profile and CT-P10 treatment pathways.

At the 30-month point, OS was 74% (95% CI, 69.2%-79.1%) and PFS was 67% (95% CI, 61.3%-72.1%) among patients (N = 382) undergoing first-line treatment with CT-P10.

Among enrollees, a complete response (CR) was observed in 82% (n = 312); partial response (PR), 12% (n = 46); no response or stable disease 4% (n = 16); and progressive disease, 2% (n = 8).

CT-P10 tolerability also was reported to be comparable to the reference product. The investigators said 90% (n = 351) of patients reported 1 or more adverse events (AEs), 65% (n = 253) experienced a grade 3 or higher event, and 28% of AEs were reported as “definitely, probably, or possibly related to CT-P10.”

“This is the first multicountry retrospective postapproval study to investigate the effectiveness and safety of CT-P10 treatment in patients with DLBCL in a real-world setting across Europe,” said Mark Bishton, MD, consultant hematologist and a clinical associate professor at the University of Nottingham, School of Medicine, England.

The European Medicines Agency approved CT-P10 for treatment of rheumatoid arthritis and certain blood cancers, including NHL, in 2017. DLBCL accounts for an estimated 30% to 40% of NHL incidence.

“The response rates, survival rates and overall safety profile for CT-P10 appear 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,” authors of the study wrote.

Discussing the second study, the investigators said rapid infusion of CT-P10 was generally well tolerated, with 10% (n = 20; 95% CI, 6%-15%) of patients experiencing infusion-related reactions (IRRs).

“We are encouraged by the results of the study, as CT-P10 has demonstrated a similar IRR rate to reference rituximab,” said HoUng Kim, PhD, head of the Medical and Marketing Division of Celltrion.

The investigators said most IRRs were grade 1/2 (96%), and the most common of these were fatigue (35%), nausea (30%), and vomiting (15%). Patients achieving CRs and PRs over 6 months of observation were 74% and 22%, respectively.

“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,” Kim said.