Date: 2017-06-17
Type of
information: Presentation of results at a congress
phase:
Announcement: presentation of results at the European League Against Rheumatism Annual Congress (EULAR)
Company: Celltrion Healthcare (South Korea)
Product: Truxima® (CT-P10 - biosimilar rituximab - biosimilar version of Mabthera®/Rituxan® )
Action
mechanism: biosimilar product/monoclonal antibody. Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. It was developed by IDEC Pharmaceuticals (now Biogen) and Roche is in charge of global sales. Ritusimab patents already expired in Europe in December 2013 and will expire in the U.S. in September 2016.
Disease: advanced follicular lymphoma, rheumatoid arthritis
Therapeutic
area: Cancer - Oncology - Autoimmune diseases - Rheumatic diseases
Country:
Trial
details:
Latest
news:
- • On June 14, 2017, Celltrion announced that 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 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 follicular lymphoma 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.1
- Findings showing comparable long-term efficacy and safety between CT-P10 and reference rituximab in rheumatoid arthritis 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.
- 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 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 rheumatoid arthritis patients who do not respond well to anti-TNF agents.
Is
general: Yes
