Biosimilar, Truxima, is non-inferior to the reference product, notes study

Data from a randomised controlled trial, presented at the International Conference on Malignant Lymphoma (ICML) has shown Truxima (CT-P10) to be non-inferior to the reference product in terms of overall and complete response rates to treatment in newly diagnosed advanced follicular lymphoma (AFL).

Truxima is a genetically engineered chimeric murine/human monoclonal immunoglobulin G1 kappa antibody that was assessed by the European Medicines Agency (EMA) as a biosimilar to rituximab, with the same therapeutic indications and dosing regimen. It has been authorised by the European Commission as the first biosimilar monoclonal antibody for the treatment of cancer.

The trial was a double-blind, randomised, Phase III study assessing the efficacy and tolerability of Truxima compared with reference intravenous rituximab (RTX). A total of 140 patients were included in the study and were assessed at three week intervals during eight treatment cycles.

Results of the study demonstrated that at 24 weeks there was no statistically significant difference between the biosimilar and reference product for progression free survival (PFS) and the overall safety profile of Truxima was consistent with RTX.

“The data presented add to the increasing wealth of evidence for biosimilar rituximab and demonstrate that CT-P10 was non-inferior in terms of efficacy and comparable in pharmacokinetics and safety to the reference rituximab for patients with advanced stage follicular lymphoma,” said Professor Bertrand Coiffier, head of the Department of Hematology at Hospices Civils de Lyon, France. “Switching to biosimilar rituximab presents opportunities for healthcare systems across the world to reduce the costs associated with oncology treatments, paving the way for greater patient access for new innovative medicines.”