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Top UK university hospital unveils data that support the use of rapid infusion for Truxima® (CT-P10, biosimilar rituximab) in patients with advanced-stage follicular lymphoma

New data from University College London Hospitals NHS Foundation Trust (UCLH) on the safety and tolerability of rapid infusion of CT-P10 were presented this weekend at the 59th American Society of Hematology (ASH) Annual Meeting. The results showed that rapid infusion of CT-P10 was well-tolerated across all patient groups and patients could be safely switched from reference rituximab to CT-P10 without reverting to slower infusion rates1 .

The independent study examined the infusion-related reactions (IRRs) in three different patient groups: rituximab naive, those switching directly from reference rituximab to CT-P10, and those that received their last dose of reference rituximab at least 6 months prior to the study.1

The administration of rituximab is associated with IRRs which occur most frequently during the first infusion. To reduce the risk of IRRs, it is the manufacturers’ recommendation that the first dose is increased every 30 minutes in 50mg/hour increments resulting in a typical rituximab infusion taking 4-6 hours. It is common practice however to administer rituximab as a rapid infusion if the first infusion is well-tolerated which reduces infusion time to just over an hour and 30 minutes.1

Mr. Simon Cheesman from the University College London Hospitals NHS Foundation Trust and one of the authors of the study said, “We felt that it was important to investigate the safety of using rapid infusion for CT-P10 as this method of infusion for reference rituximab is of significant benefit to patients, taking hours off their treatment time. The findings from the study should help to increase physician confidence and facilitate the introduction of CT-P10 at centres prescribing rituximab across the UK and beyond”.

Man Hoon Kim, President and CEO of Celltrion Healthcare, welcomed the findings from UCLH’s study commenting: “The study by UCLH is of significant importance as it demonstrates that CT-P10 can be safely administered as a rapid infusion without physicians having to revert to the slower infusion rate. This not only saves hospitals’ valuable time and resources but also greatly improves the patient experience”.

The ASH meeting also saw Celltrion Healthcare present pharmacokinetic (PK) data for CT-P10, which compared the PK properties of CT-P10 and reference rituximab according to several relevant clinical factors in patients with advanced-stage follicular lymphoma. The results showed that the PK of CT-P10 is in accordance with historical data about reference rituximab and further supports the PK similarity between CT-P10 and reference rituximab across all patient sub-groups2 .

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Notes to editors:

About CT-P10 (biosimilar rituximab)

CT-P10 is a mAb that targets CD20, a transmembrane protein found on the surface of most B cells. By binding specifically to CD20, CT-P10 depletes B cells by three main mechanisms: Induction of apoptosis, stimulation of CDC (complement-dependent cytotoxicity) and stimulation of ADCC (antibody-dependent cell-mediated cytotoxicity).

CT-P10 is approved in the EU for the treatment of patients with Non-Hodgkin lymphoma (NHL), chronic lymphocytic leukaemia, rheumatoid arthritis, 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).3

About Advanced FL

Follicular lymphomas are the second most frequent subtype of nodal lymphoid malignancies in Western Europe4 and are a subtype of NHL.5 It is a slow-growing lymphoma that develops from B lymphocytes (B cells). It is characterized 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 advent of rituximab, overall survival has increased to in excess of 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 CT-P10 Advanced FL 24 week study 6

This Phase III, randomised, parallel-group, active-controlled, double-blind study aims to demonstrate equivalence of pharmacokinetics and non-inferiority of efficacy for CT-P10 in comparison with reference rituximab, each administered in combination with cyclophosphamide, vincristine, and prednisone (CVP) in patients with advanced FL.

A total of 121 patients were included in the results presented at the ASH meeting.2 Fifty-nine patients in the CT-P10 group and 62 patients in the reference rituximab group received CT-P10 or reference rituximab plus CVP every 3 weeks over 8 cycles. No statistically significant differences were found between the two groups in PK properties in all subgroup analyses.

Data previously published in The Lancet Haematology in 2017 showed that CT-P10 was non-inferior to reference rituximab in advanced FL in terms of efficacy.7

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 Shah et al. Evaluation of the Safety and Tolerability of Rapid Infusion of Biosimilar Rituximab Truxima® - the University College London Hospitals (UCLH) Experience. 59th Annual Meeting of the American Society of Hematology (ASH). 2017. 3387.

2 Won Seog Kim et al. Clinical Factors Impact on Pharmacokinetics of CT-P10 and Reference Rituximab in Patients with Advanced-Stage Follicular Lymphoma. 59th Annual Meeting of the American Society of Hematology (ASH). 2017. 1504.

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

4 Dreyling, M, et al. Newly diagnosed and relapsed follicular lymphoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016;27(suppl 5):v83-v90 doi:10.1093/annonc/mdw400.

5 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 [accessed December 2017].

6 Phase 3, Randomised, Parallel-Group, Active-Controlled, Double-Blind Study to Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan, Each Administered in Combination With Cyclophosphamide, Vincristine, and Prednisone (CVP) in Patients With Advanced Follicular Lymphoma [last accessed December 2017]. Available at: https://clinicaltrials.gov/ct2/show/NCT02162771 .

7 Won Seog Kim et al. Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 compared with rituximab in patients with previously untreated advanced-stage follicular lymphoma: a randomised, double-blind, parallel-group, non-inferiority phase 3 trial. The Lancet Haematology 4.8 (2017): e362-e373.

Contact:

Hanover for Celltrion Healthcare
Emma Gorton
egorton@hanovercomms.com
+44 (0)20-3817-6591
or
Georgia Featherston
gfeatherston@hanovercomms.com
+44 (0)20-3817-6718

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