Celltrion Healthcare Showcases Data Supporting The Efficacy And Safety Of Truxima (CT-P10, Biosimilar Rituximab) In Advanced Follicular Lymphoma And Rheumatoid Arthritis

INCHEON, South Korea--(BUSINESS WIRE)--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. ^1,2,3

The data from the randomised, double-blind, controlled phase III study in 140 advanced 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.¹

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

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.²

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 analysis³ 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 rituximab⁴ 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.⁴

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.”

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Notes to editors:

About CT-P10 (biosimilar rituximab)

CT-P10 is a mAb that targets CD20, a protein found on the surface of most B cells. Overactive B cells can stimulate attack of healthy cells in immune-related diseases such as RA. B cells are also implicated in some types of hematological cancer including NHL and CLL. B cells express CD20 at many stages of their development making the protein a good target for treatments.

CT-P10 is approved in the EU for the treatment of people with NHL, CLL, RA, granulomatosis with polyangiitis and microscopic polyangiitis. Further details of the approved indications and safety information for CT-P10 are available in the summary of product characteristics (SmPC).⁵

About advanced follicular lymphoma

Follicular lymphomas are the second most common subtype of nodal lymphoid malignancies in Western Europe⁶ and are a subtype of non-Hodgkins lymphoma.⁷ Follicular lymphoma is a slow-growing lymphoma that develops from B lymphocytes (B cells). It is characterised by painless swelling of the lymph nodes, fever for no apparent reason, drenching night sweats, fatigue, infections and bleeding. Most cases are advanced at the time of diagnosis but since the arrival of rituximab, overall survival has increased to over 20 years. It is called ‘follicular’ lymphoma because the abnormal lymphocytes often collect in lymph nodes in clumps that are known as ‘follicles’. Follicular lymphoma is more common in people aged over 65, but it can occur in people of any age.

About rheumatoid arthritis

In Europe, more than 2.9 million people have rheumatoid arthritis (RA), many of whom are of working age. On average, every third person with RA becomes work disabled and up to 40 per cent leave work completely within 5 years of diagnosis.⁸ Although there is no cure for RA, there are many treatments that can reduce inflammation and ease pain. As with all rheumatic diseases early diagnosis and intervention is key.

About Celltrion Healthcare

Celltrion Healthcare conducts the worldwide marketing, sales and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries. Celltrion Healthcare’s products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US Food and Drug Administration (FDA) cGMP guidelines and the EU GMP guidelines. For more information please visit: http://www.celltrionhealthcare.com/

References

¹ Kim, Won Seog et al. Double blind, randomised, phase 3 study to compare efficacy and safety of the biosimilar CT-P10 rituximab combined with CVP therapy in patients with previously untreated advanced-stage follicular lymphoma. The International Conference on Malignant Lymphoma. 2017. 223

² Suh et al. Randomised double-blind study shows comparable long-term efficacy and safety between rituximab biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: 48 week results. Annual European Congress of Rheumatology (EULAR). 2017. SAT0146.

³ Yoo. et al. Rituximab is effective in the treatment of Rheumatoid Arthritis regardless of Body Mass Index. Annual European Congress of Rheumatology (EULAR). 2017. FRI0178

⁴ Yoo. et al. A randomized, controlled, double-blind, parallel-group, phase 3 Study to compare the pharmacokinetics, efficacy and safety between CT-P10, Rituxan and MabThera in patients with rheumatoid arthritis. Available at https://covalentdata.com/clinical-trial/NCT02149121.

⁵ Truxima concentrate for solution for infusion summary of product characteristics [last accessed June 2017]. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004112/WC500222694.pdf.

⁶ Dreyling, M, et al. Newly diagnosed and relapsed follicular lymphoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology. 2011;22(suppl 6):vi59-vi63.

⁷ Kohrt HEK, Ugarte A. Follicular Lymphoma: a Guide for Patients. European Society for Medical Oncology. 2014. Available at: https://www.esmo.org/content/download/52236/963497/file/EN-Follicular-Lymphoma-Guide-for-Patients.pdf [Last accessed June 2017].

⁸ NRAS, European Fit for Work Report. Available at www.nras.org.uk/european-fit-for-work-report. [Last accessed June 2017].