Business Wire

New Phase II data indicate regimen of Truxima® (biosimilar rituximab), lenalidomide and acalabrutinib (R2A) may be well tolerated and effective in relapsed/refractory aggressive B-cell lymphoma

Share

Data presented as part of the Virtual Edition of the 25th EHA Annual Congress (EHA25 Virtual Congress) show that a regimen of Truxima® (biosimilar rituximab), lenalidomide and acalabrutinib (R2A) may be well tolerated and effective in relapsed/refractory aggressive B-cell lymphoma.1 Lenalidomide and Bruton’s tyrosine kinase (BTK) inhibitors have shown potential in the treatment of aggressive B-cell lymphoma, and recent studies suggest both agents may be particularly effective in a subset of large B-cell lymphomas. The objective of this Phase II clinical trial was to evaluate the toxicity and efficacy of the R2A regimen in relapsed/refractory aggressive B-cell lymphoma.1

Between the first enrolment in July 2019 and the data cut-off in February 2020, a total of 22 patients were treated with a median follow up of 3.2 months. The majority of patients (73%) had non-germinal centre B-cell like diffuse large B-cell lymphoma (non-GCB DLBCL). In each cycle of treatment, patients were treated with rituximab 375mg/m2 day 1 intravenous injection, lenalidomide 20mg day 1 to day 21 once daily, and acalabrutinib 100mg day 1 to day 28 twice daily. Each cycle of treatment was delivered over 4 weeks (28 days), and each patient received 6 cycles. Acalabrutinib maintenance therapy was then given in responders for up to one year.1

The primary endpoint for this single arm, multicenter, investigator-initiated study was the overall response rate (ORR) and secondary endpoints included complete remission (CR) rate, progression free survival (PFS), overall survival (OS) and safety profile. In the 13 patients who underwent disease assessment following the R2A regimen, objective response was observed in 69% of patients and CR was observed in 31% of patients. The 6-month PFS rate was 83% and only one patient experienced disease progression after the initial objective response.1

Throughout the study, out of 22 patients, dose reduction was performed in 3 and 1 patients for lenalidomide and acalabrutinib respectively due to haematologic toxicities. 3 patients experienced higher than grade 2 toxicity and the most common adverse event regardless of grade was skin toxicity, observed in 4 patients. The data indicate that the R2A regimen was therefore well tolerated in Korean relapse/refractory B-cell lymphoma patients, with initial analysis in non-GCB DLBCL patients showing a promising response.1

Combination regimens can improve patient outcomes, however, combining high-cost treatments can make the cost unsustainable. Payers are therefore increasingly looking for new pricing models and ways to manage the budget impact of combination treatments.2 The introduction of biosimilar rituximab to the R2A regimen may have the potential to reduce the overall cost of treatment.

Youngil Koh, Associate Professor at Seoul National University Hospital and principal investigator of the trial, said, “Despite the introduction of new drugs for the treatment of lymphoma, there has been rising concern over the cost of treatment. Biosimilars have the potential to explore better treatment regimens and increase access to novel drugs and new regimens. By incorporating biosimilar rituximab into combination therapies alongside new drugs, the overall cost burden can be reduced, enhancing patient access.”

Mr. Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare said, “There is a rising interest towards lenalidomide and acalabrutinib in the haematology community and Celltrion Healthcare is committed to continuing its innovative research into new regimens such as R2A combination therapy to support patient care.”

Recently, the WHO recognised the importance of access to rituximab and awarded prequalification to Truxima ® , making this the first rituximab similar biotherapeutic product to be prequalified by the organisation.3 Mr Kim said, “The prequalification of this treatment marks another step forward in making this medicine available in many countries around the world as an affordable therapeutic option.”

-- ENDS --

Notes to Editors:

About diffuse large B-cell lymphoma (DLBCL) 4,5,6,7

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)3,8

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® 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. 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 Koh, Y., Park, C., Byun, J., et al. Rituximab, lenalidomide and acalabrutinib (R2A) for relapsed/refractory aggressive B-cell lymphoma: Interim analysis reporting good tolerability and potential durable response. Poster presented at: EHA25 Virtual Congress; June 12, 2020
2 Sherwin, G et al. Payer Management Of High-Cost Brand-On-Brand Combination Therapies In Oncology. Value in Health. 2017;20(9):A461. Doi: https://doi.org/10.1016/j.jval.2017.08.357
3 First rituximab similar biotherapeutic products prequalified. World Health Organization. Available at: https://extranet.who.int/prequal/news/first-rituximab-biotherapeutic-products-prequalified Last accessed June 2020
4 NHL subtypes. Leukemia & Lymphoma Society. Available at: https://www.lls.org/lymphoma/non-hodgkin-lymphoma/diagnosis/nhl-subtypes Last accessed June 2020
5 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
6 Vivek Kumar, Sarvadaman Makardhwaj Shrivastava, Trishala Meghal and Binod Abhinav Chandra (June 27th 2018). Recent Advances in Diffuse Large B Cell Lymphoma, Hematology - Latest Research and Clinical Advances, Margarita Guenova and Gueorgui Balatzenko, IntechOpen, DOI: 10.5772/intechopen.74263. Available from: https://www.intechopen.com/books/hematology-latest-research-and-clinical-advances/recent-advances-in-diffuse-large-b-cell-lymphoma Last accessed June 2020
7 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 June 2020
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 June 2020

Contact information

For further information please contact:

Zuzanna Grzeskiewicz
zgrzeskiewicz@hanovercomms.com
+44 (0)7506 339043

Sophia Eminson
seminson@hanovercomms.com
+44 (0)7751 116252

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

VR Fitness Developer FitXR Secures $7.5 Million In Series A Venture Round Led by Hiro Capital10.7.2020 09:00:00 EESTPress release

FitXR, the leading VR fitness company, today announces that it has secured $6.3m in investment funding, led by Hiro Capital, with continued support from U.S.-based BoostVC, Maveron and TenOneTen Ventures, together with an additional $1.2m in the form of an innovation loan, from Innovate UK. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200709005856/en/ Cherry Freeman, Co-Founding Partner, Hiro Capital (Photo: Business Wire) FitXR, who had previously secured $1.25 million in seed funding from investors, will use the new investment to expand its operations in Europe and North America, and to accelerate launch of several exciting new products and services for people to keep fit in Virtual Reality. The investment marks a significant show of belief in FitXR, who over the last year has grown to become one of the leaders of the VR fitness sector, with its mission to put the fun back into fitness. Its first product, the boxing rhyt

Laboratory Studies Confirm BETADINE® Antiseptic Products’ Effectiveness Against COVID-19 Virus10.7.2020 01:37:00 EESTPress release

Mundipharma today announced that laboratory testing at the Duke-NUS Medical School in Singapore, has confirmed the effectiveness of its BETADINE® antiseptic products against the novel coronavirus (SARS-CoV-2) which causes COVID-19 disease. Testing has demonstrated BETADINE’s® strong in-vitro virucidal activity, killing 99.99% of the SARS-CoV-2 virus in 30 seconds. The products subjected to testing were: BETADINE® antiseptic products, namely Solution (10% PVP-I), Skin Cleanser (7.5% PVP-I), Gargle and Mouthwash (1.0% PVP-I) and Throat Spray (0.45% PVP-I). The research has been published in the respected Infectious Disease and Therapy Journal on 08 July 2020. “These results confirm our view that BETADINE® antiseptic products, used appropriately and in conjunction with other preventative treatment options including PPE, can play a role in limiting the spread of infections, including COVID-19,” said Raman Singh, CEO Mundipharma. “It also provides the medical community as well as consumers

New Evidence Shows Morinaga Milk’s Probiotic Bifidobacterium breve A1 Improves Memory of Older Adults With Cognitive Dysfunction9.7.2020 21:00:00 EESTPress release

Morinaga Milk Industry Co., Ltd. (TOKYO:2264), a leading Japanese dairy product company and a key global probiotics manufacturer, confirmed that its proprietary probiotic strain Bifidobacterium breve A1 (a.k.a. B. breve MCC1274) is safe and effective for improving memory functions of older adults with suspected mild cognitive impairment (MCI) in a randomized, double-blind, placebo-controlled trial (RCT). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200709005032/en/ Figure 1. Changes of RBANS scores at 16 weeks from baseline. Values are indicated as mean with error bars as the standard error. **p<0.001, ***p<0.0001, inter-group difference, Student’s t-test. (Graphic: Business Wire) The new study, published recently in the Journal of Alzheimer’s Disease, has produced breakthrough results uncovering a novel promising probiotic intervention for early dementia prevention. The clinical study conducted by a clinical research orga

rf IDEAS and Ricoh Simplify Secure Access to Multifunction Printers9.7.2020 19:05:00 EESTPress release

rf IDEAS, a leading manufacturer of credential readers for authentication and logical access, today announced with Ricoh the integration of its WAVE ID® Plus dual-frequency card reader technology with Ricoh’s Smart Operation Panel (SOP), Gen 2.5. The new WAVE ID Ricoh Universal SOP Reader is the most innovative reader for secure pull-print applications with Ricoh multifunction printers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200709005764/en/ WAVE ID® Ricoh Universal SOP Reader (Photo: Business Wire) rf IDEAS and Ricoh have a proven record of working together to deliver secure workplace solutions that feature the most advanced identification and authentication capabilities. “As we continue our worldwide partnership with a leader in the print industry, we are delighted that Ricoh chose rf IDEAS to develop an innovative credential reader design that connects to its A3 multifunction devices,” said Tod Besse, senior vice

Immersive Labs Adds Tenable Co-Founder and Security Industry Veteran Jack Huffard to its Board of Directors as Demand for Improving and Measuring Cyber Talent Grows9.7.2020 18:46:00 EESTPress release

Immersive Labs, the company empowering organizations to equip, exercise, and evidence human cyber capabilities, announced Jack Huffard, a co-founder and board member of Tenable (Nasdaq: TENB) will join its board of directors to help drive growth. This comes on the heels of Immersive Labs’ recent expansion into the U.S. market, backed by Goldman Sachs and Summit Partners with $50M in financing, after four successful years of fast-growth and an impressive customer roster in the UK and the U.S. With the addition of Huffard to the board, a cybersecurity industry business leader who helped Tenable through its fast growth and successful IPO, the Immersive Labs team is well-suited for its next phase of innovation and market leadership. Huffard also currently serves as a board director for Norfolk Southern Corporation (NYSE: NSC) and is a member of the National Security Telecommunications Advisory Committee (NSTAC), helping the US government navigate pressing national security issues and stren

Jonckers Announces New CEO9.7.2020 18:08:00 EESTPress release

Jonckers, a global leader in language platform technology and multilingual solutions, today announced that its Board of Directors has appointed Silke Zschweigert as Chief Executive Officer, effective immediately. Zschweigert previously held the position of Chief Revenue Officer. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200709005715/en/ Silke Zschweigert Newly appointed CEO of Jonckers - a global leader in language platform technology and multilingual solutions (Photo: Business Wire) “I’m very privileged to be asked by the Board to be the next CEO of this dynamic and forward-thinking company,” said Zschweigert. “The company transitioned from being a pure language service provider to an AI-driven Language Platform with a multilingual community. I look forward to scaling this capability and further developing advanced solutions creating significant value for Enterprises going global.” Zschweigert succeeds Geo Janssens who

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom