New data presented at the International Conference on Malignant Lymphoma (ICML) and the European League Against Rheumatism (EULAR) congress 2017 demonstrate that CT-P10 is comparable to reference rituximab in terms of efficacy and safety in both oncology and autoimmune disease indications.
The data from the randomised, double-blind, controlled Phase III study in 140 advanced follicular lymphoma (FL) patients, presented at the ICML in Lugano, Switzerland, showed that CT-P10 was non inferior in terms of efficacy compared to reference rituximab, when each were given in combination with standard chemotherapy of cyclophosphamide, vincristine and prednisone (CVP) in patients with previously untreated advanced FL over eight cycles.
The findings from the study also showed that the safety profile, pharmacokinetics, pharmacodynamics and immunogenicity of CT-P10 were comparable to those of reference rituximab.
Prof Coiffier, Head of the Department of Hematology at Hospices Civils de Lyon, France said: “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. 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.”
Findings showing comparable long-term efficacy and safety between CT-P10 and reference rituximab in RA patients treated over 48 weeks were also presented at EULAR. No clinically meaningful differences were found between the respective groups who took part in the randomised 372-patient study.
Dr Kwon, Medical Director of Celltrion Healthcare, said: “Our studies consistently demonstrate the equivalence and comparability of our biosimilar rituximab, CT-P10, to reference rituximab. We are the only company that is able to proudly state that we have conducted phase III clinical trials looking into the safety and efficacy of its biosimilar in two indications – rheumatoid arthritis and non-Hodgkin’s lymphoma, which is a testament to our commitment to providing quality biosimilar treatments for patients supported by robust clinical data.”
Alongside the data demonstrating sustained efficacy over 48 weeks presented at the congress, a post-hoc analysis investigating the impact of body mass index (BMI) on clinical response using data from the Phase III randomised controlled trial (RCT) that demonstrated clinical equivalence between a biosimilar rituximab, CT-P10 and reference rituximab indicates that clinical response to both biosimilar and reference is unaffected by BMI over 48 weeks. These data are in contrast to the known association between high BMI and inadequate clinical response to anti-tumour necrosis factor (TNF) agents, and suggest that rituximab is an effective treatment option for obese RA patients who do not respond well to anti-TNF agents.
Dr Dae-Hyun Yoo, Global Principal Investigator of the RA study and Professor of Medicine at Hanyang University Hospital for Rheumatic Diseases, College of Medicine, Hanyang University, Republic of Korea, said: “The data in support of CT-P10 are very encouraging, as it means that biosimilar rituximab could prove a reasonable therapeutic alternative to patients with rheumatoid arthritis who have a high BMI and have had an inadequate response to anti-TNFs.”