CelltrionHealthcare

SAN DIEGO--(BUSINESS WIRE)--Celltrion Healthcare today presented new data at the American Society of Hematology Meeting (ASH) 2018, which shows that the efficacy and safety of CT-P10 is comparable to reference rituximab in patients with advanced follicular lymphoma (AFL) over two years.1

The efficacy and safety of CT-P10 was evaluated in a randomized, double-blind, Phase III study which evaluated the overall survival (OS), progression-free survival (PFS), and sustained response in comparison to the reference biologic rituxan. The median follow-up duration was 23 months.i

140 patients were enrolled in a 1:1 ratio and 124 patients completed eight cycles of chemotherapy (R-CVP induction). 122 patients (62 patients in the CT-P10 group and 60 patients in the reference rituximab group) who showed response during the induction period, entered the maintenance period where a total of 12 cycles of rituximab monotherapy was to be administered every two months.i

The results showed that at the median follow-up duration of 23 months, the updated efficacy data in AFL patients demonstrated comparable OS (2-year OS of 93.2% and 95.3% for CT-P10 and reference rituximab, respectively) and PFS (2-year PFS was 75.2% and 73.5% for CT-P10 and reference rituximab, respectively). In terms of sustained response, the proportion of patients who showed relapse or disease progression after achieving overall response was 19.4% (13/67) in the CT-P10 group and 21.3% (13/61) in the reference rituximab group. CT-P10 was also well-tolerated and its safety profile including immunogenicity of CT-P10 was comparable to that of reference rituximab over 23 months of treatment.i

Christian Buske, Professor, Medical Director at the Comprehensive Cancer Center Ulm, Germany, Institute of Experimental Cancer Research and Attending Physician and Professor of Medicine at the Medical Department for Internal Medicine III, Hematology/Oncology, University Hospital Ulm said, “CT-P10 has already demonstrated non-inferiority of efficacy compared with reference rituximab combined with CVP in previously untreated AFL. The study results presented today have further strengthened these findings, showing no statistically meaningful difference between CT-P10 and reference rituximab for over two years and demonstrating a proven safety profile. I believe that these results will help to further increase physician confidence in using rituximab biosimilars and will broaden AFL patient access to efficacious and affordable therapies.”

Mr HoUng Kim, Head of Strategy and Operations Division, Celltrion Healthcare, said: “The two-year study marks another significant milestone for Celltrion Healthcare, showing that CT-P10 is comparable to reference rituximab in terms of overall survival and progression-free survival. Now that CT-P10 is approved in the US, the availability of the first rituximab biosimilar has the potential to significantly improve access to rituximab for patients with non-Hodgkin’s lymphoma indications. As a cost-effective alternative to the reference product, CT-P10 will reduce the burden on healthcare systems resulting in better patient outcomes.”

Also presented at ASH and published in The Lancet Haematology, is data from the CT-P10 3.4 LTBFL trial which aimed to demonstrate therapeutic equivalence of CT-P10 to reference rituximab (as monotherapy) in patients with previously untreated Low Tumor Burden Follicular Lymphoma (LTBFL).2

The results showed that CT-P10 was well-tolerated and the safety profile was comparable to that of reference rituximab over seven months. 108 (83%) of 130 patients assigned to CT-P10 and 104 (81%) of 128 assigned to rituximab achieved an overall response by month seven (treatment difference estimate 1·8%; 90% CI –6·43 to 10·20) and therapeutic equivalence was shown (90% CIs were within the prespecified margin of 17%).ii

CT-P10 is the first rituximab biosimilar to be approved in the United States.3

--- Ends---

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).4 Celltrion and Teva Pharmaceutical Industries Ltd. entered into an exclusive partnership in October 2016 to commercialize CT-P10 (Truxima®) in the U.S. and Canada.

About Advanced FL
Follicular lymphomas are the second most frequent subtype of nodal lymphoid malignancies in Western Europe5 and are a subtype of NHL.6 It 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 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 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, WS, et al. Similar Efficacy and Safety of CT-P10 and Reference Rituximab in Patients with Advanced Stage Follicular Lymphoma: Updated Phase III Study Results. 60th American Society of Hematology (ASH) Annual Meeting & Exposition 2018; 1616.

2 Ogura, M, et al. Comparison of Efficacy and Safety of Biosimilar CT-P10 to Rituximab in Patients with Previously Untreated Low Tumor Burden Follicular Lymphoma (LTBFL): A Randomized Phase III Study. 60th American Society of Hematology (ASH) Annual Meeting & Exposition 2018; 1596.

3 FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm627009.htm [last accessed December 2018].

4 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.

5 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.

6 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 December 2018].