Celltrion Releases First Real-world Data for Its Rituximab Biosimilar in DLBCL

Celltrion Healthcare published new real-world data demonstrating the clinical effectiveness of its biosimilar rituximab (Truxima, CT-P10) in patients with diffuse large B-cell lymphoma (DLBCL) at the European Hematology Association (EHA) 2021 Virtual Congress.

Truxima received marketing authorization from the European Medicines Agency in 2017 for the treatment of rheumatoid arthritis and certain blood cancers, including DLBCL, the most common subtype of non-Hodgkin lymphoma (NHL) that represents an estimated 30% to 40% of adult cases. Truxima was the first rituximab biosimilar approved in the United States. It launched on the US market in 2019 in partnership with Teva Pharmaceutical Industries.

The company ran a noninterventional postauthorization safety study, during which researchers collected patient data from hospital medical records for 382 patients with DLBCL who received CT-P10 therapy in the United Kingdom, Spain, France, Germany, or Italy. Treatment pattern data were retrospectively collected during a 30-month observation period.

“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 Mark Bishton, PhD, consultant hematologist and honorary clinical associate professor at the University of Nottingham School of Medicine in the United Kingdom, in a statement.

The results met the primary end points of overall survival, progression-free survival, and summary of best responses. Thirty months after receiving their first dose of CT-P10, 67% (95% CI, 61.3%-72.1%) of patients had not experienced disease progression and the overall survival was 74% (95% CI, 69.2%-79.1%).

Additionally, 82% (n = 312) of patients achieved a complete response and 12% (n = 46) achieved a partial response 30 months post index. Only 4% (n = 16) experienced no response and 2% (n = 8) experienced disease progression.

Secondary end points for CT-P10’s safety profile and treatment pathways were also examined. Patients generally found CT-P10 to be tolerable, and the number of adverse events reported was comparable with that reported for the reference product (Rituxan).

In total, 2504 adverse events were reported and 90% (n = 351) of patients reported at least 1 adverse event; 65% (n = 253) experienced an adverse event of grade 3 or higher and 28% (n = 109) were determined to be possibly, probably, or definitely related to treatment.

Celltrion also released real-world data on rapid infusion of CT-P10 in 192 patients with NHL and chronic lymphocytic leukemia (CLL) at the EHA Updates-in-Hematology. Typically, infusion of rituximab in Europe is conducted through a slow initial infusion rate with a gradual upward titration. Rapid infusion is often reserved for when patients receive subsequent infusions after experiencing no serious complications after the first dose.

The study was the first multicountry study containing real-world evidence evaluating the safety and efficacy of rapid infusion of CT-P10. The results showed that rapid infusion of the biosimilar was well tolerated, with only 10% (n = 20; 95% CI, 6.0%-15.0%) of patients reporting an infusion-related reaction (IRR).

Overall, 96% of the reported reactions were grade 1 or 2. Among the 20 patients who experienced IRRs, the most common reactions were fatigue (35%; n = 7), nausea (30%; n = 6), and vomiting (15%; n = 3).

At the end of the 6-month observation period, 74% of patients (n = 142) achieved a complete response and 22% (n = 42) achieved a partial response.

“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,” said HoUng Kim, PhD, head of the Medical and Marketing Division at Celltrion, in a statement.