• The multi-country retrospective post-approval study is the first to investigate the safety and effectiveness of Truxima^� (biosimilar rituximab, CT-P10) in patients with diffuse large B-cell lymphoma�(DLBCL) in a real-world setting.

INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Healthcare today presented new data from its post-approval study evaluating the real-world clinical effectiveness and safety of Truxima^� (biosimilar rituximab, CT-P10) in patients with diffuse large B-cell lymphoma (DLBCL) at the European Hematology Association (EHA) 2021 Virtual Congress.¹

CT-P10 was granted European Medicines Agency approval in 2017 for the treatment of rheumatoid arthritis (RA) and specific blood cancers, including non-Hodgkin�s lymphoma (NHL).² DLBCL is the most common subtype of NHL, representing an estimated 30-40% of adult cases.^3,4,5,6

This non-interventional post-authorisation safety study (PASS) involved the collection of patient-level data from hospital medical records for patients with DLBCL who received CT-P10 treatment in five European countries (United Kingdom, Spain, France, Germany and Italy). CT-P10 treatment pattern data were collected retrospectively during the 30-month observation period and patients were selected based on the treatment they received as part of their standard clinical care in a real-world setting.

The primary endpoints were overall survival (OS), progression free survival (PFS) and summary of best responses and secondary endpoints included safety profile and CT-P10 treatment pathways. At 30-months post-index, amongst patients taking first-line CT-P10, 67% (95% confidence interval [CI] 61.3�72.1) had not experienced disease progression, with 74% (95% CI 69.2�79.1) overall survival. Of the 382 patients observed, over three quarters initiated on CT-P10 achieved complete or partial response by 30 months, with 82% having recorded a complete response (n=312). Partial response was seen in 12% (n=46), no response or stable disease in 4% (n=16) and progressive disease in 2% (n=8).

CT-P10 also appeared to be generally well tolerated by patients, with adverse events (AEs) consistent with those reported for reference rituximab. Overall, 90% (n=351) of patients reported at least one AE (total AEs n=2,504); 65% (n=253) experienced a grade 3 or higher AE, and 28% (n=109) were recorded as definitely, probably, or possibly related to CT-P10.

�This is the first multi-country retrospective post-approval study to investigate the effectiveness and safety of CT-P10 treatment in patients with DLBCL in a real-world setting across Europe,� said Dr. Mark Bishton, Consultant Haematologist and Honorary Clinical Associate Professor at the University of Nottingham, School of Medicine. �Over three quarters of patients initiated on CT-P10 achieved complete or partial response by 30 months. The response rates, survival rates and overall safety profile for CT-P10 appears consistent with those reported for reference rituximab, which could support the use of CT-P10 in combination with chemotherapy as a therapeutic option for DLBCL.�

Celltrion Healthcare also presented real-world data on rapid infusion of CT-P10 in patients with non-Hodgkin�s lymphoma (NHL) and chronic lymphocytic leukaemia (CLL) at the EHA Updates-in-Hematology.⁷ The study was the first multi-country study to investigate the safety and effectiveness of rapid infusion of CT-P10 in a real-world setting. Safety results suggest that rapid infusion of CT-P10 was generally well tolerated, with only 10% (n=20; 95% CI: 6 � 15%) of patients experiencing an infusion-related reaction (IRR). The majority of IRRs were grade 1 or 2 (96%), with the most common IRR being fatigue (35% n=7/20 of the patients with index IRRs), followed by nausea (30% n=6/20) and vomiting (15% n=3/20). In terms of response, the majority of patients achieved a complete response (74% n=142/192) or partial response (22% n=42/192) over the 6-month observation period.

�The recommended protocol for rituximab infusion in Europe is a slow initial infusion rate with a gradual upward titration. Rapid infusion is often used in subsequent infusions for patients who had no serious complications related to the first infusion,� said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. �We are encouraged by the results of the study as Truxima has demonstrated a similar IRR rate to reference rituximab. This will allow informed, evidence-based decisions on cost-effective treatment strategy for patients with CLL or NHL.�

- ENDS -

Notes to Editors:

About diffuse large B-cell lymphoma (DLBCL)^3,4,5,6

There are more than 60 different subtypes of non-Hodgkin�s lymphoma (NHL), however diffuse large B-cell lymphomas (DLBCLs) are the most common subtype accounting for 30-40% of adult NHLs. Global epidemiological data is limited, however it is thought that the incidence is 7 cases per 100,000 people.

DLBCL is an aggressive condition and it is common to find patients with advanced disease at the point of diagnosis. The most commonly exhibited symptom is one or more painless swellings, and other general symptoms include heavy sweating at night, high temperatures that arise with no obvious cause and weight loss. Of DLBCL patients, 30-40% are thought to relapse and 10% of patients have refractory disease. Patients with relapsed refractory DLBCL if left untreated have a life expectancy of 3 to 4 months.

About Truxima^� (biosimilar rituximab)^8,9

Truxima^� is a mAb that targets CD20, a transmembrane protein found on the surface of most B-cells. By binding specifically to CD20, Truxima^� 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). Truxima^� is approved in the EU for the treatment of patients with non-Hodgkin lymphoma (NHL), chronic lymphocytic leukaemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis. Truxima^� is the first rituximab similar biotherapeutic product to be prequalified by the World Health Organization (May 2020).

About Celltrion Healthcare

Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients� access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us

References

¹ Bishton. M., et al. Real World Clinical Effectiveness and Safety of CT-P10 in Patients with Diffuse Large B-Cell Lymphoma: Results from a European Non-Interventional Post Authorization Safety Study. EHA 2021, Abstract #EP529.

² European Medicines Agency Summary of Product Characteristics (SmPC). Truxima. Available at https://www.ema.europa.eu/en/documents/product-information/truxima-epar-product-information_en.pdf Last accessed May 2021.

³ NHL subtypes. Leukemia & Lymphoma Society. Available at: https://www.lls.org/lymphoma/non-hodgkin-lymphoma/diagnosis/nhl-subtypes Last accessed May 2021.

⁴ Raut LS, Chakrabarti PP. Management of relapsed-refractory diffuse large B cell lymphoma. South Asian J Cancer. 2014;3(1):66?70. doi:10.4103/2278-330X.126531.

⁵ Vivek Kumar et al. Recent Advances in Diffuse Large B Cell Lymphoma. Available from: https://www.intechopen.com/books/hematology-latest-research-and-clinical-advances/recent-advances-in-diffuse-large-b-cell-lymphoma Last accessed May 2021.

⁶ Diffuse large B cell lymphoma. Cancer Research UK. Available at: https://www.cancerresearchuk.org/about-cancer/non-hodgkin-lymphoma/types/diffuse-large-B-cell-lymphoma Last accessed May 2021.

⁷ Celltrion Healthcare, data on file.

⁸ European Medicines Agency Summary of Product Characteristics (SmPC). Truxima. Available at https://www.ema.europa.eu/en/documents/product-information/truxima-epar-product-information_en.pdf Last accessed May 2021

⁹ First rituximab similar biotherapeutic products prequalified. World Health Organization. Available at: https://extranet.who.int/prequal/news/first-rituximab-biotherapeutic-products-prequalified Last accessed May 2021

Contacts

For further information please contact:

Holly Barber

[email protected]
+44 (0) 7759 301620

Donna Curran

[email protected]
+44 (0) 7984 550312