Business Wire

Kyowa Kirin International: New Real World Evidence Underlines Benefits of POTELIGEO ® ▼ (mogamulizumab) Treatment for Cutaneous T-cell Lymphoma (CTCL) Patients

Share

Kyowa Kirin International PLC (Kyowa Kirin), a wholly owned subsidiary of Kyowa Kirin Co., Ltd., today announced a new study of real world data showing higher response rates than previously seen in people living with cutaneous T-cell lymphoma (CTCL) treated with POTELIGEO® (mogamulizumab). The findings, from a retrospective observational study of French CTCL patients, showed that the best overall response rate in the real-life study was 58.5 per cent, compared to 35 per cent seen in the MAVORIC trial.1,2 The MAVORIC study was the pivotal Phase 3 trial that investigated treatment with POTELIGEO® compared to an active comparatora in previously treated adult patients with mycosis fungoides (MF) and Sézary syndrome (SS), two types of CTCL.

Professor Martine Bagot of Saint-Louis Hospital, Université de Paris, France said: “The purpose of the study was to assess, for the first time, the efficacy and safety of mogamulizumab in a real-life setting. We saw a higher response in the real-life study compared to the MAVORIC trial results. The increase was also seen in both the MF and SS patient groups, compared to MAVORIC. As both the real world data and MAVORIC recruited a broadly similar set of patients, this new data underlines the value of mogamulizumab in treating these CTCL patients, whose disease causes a severe impact on their functioning, emotional and social wellbeing.”

Data was collected and analysed from medical records of 124 MF and SS patients treated with POTELIGEO between February 2014 and March 2020, from 14 specialist treatment centres in France. The best overall response rate (ORR) seen in the real-life study was 47.0% in MF patients and 68.3% in SS patients. In contrast, the ORRb in MAVORIC was 21% and 37%, respectively.1,2 Of the 124 patients who received POTELIGEO treatment in the study, 44% were MF patients and 56% were SS patients. This compares to 56% and 44% in MAVORIC, respectively. In the real-life study, 49.6% of patients were at disease stage IVA1, compared to 39% in MAVORIC.1,2

POTELIGEO was also shown to have a favourable safety profile, in the real life study the most common drug-related treatment-emergent adverse events (TEAEs) were lymphopenia and asthenia. Commonly occurring TEAEs seen in both the real life study and MAVORIC were rash and infusion-related reactions.1,2

Abdul Mullick, President of Kyowa Kirin International, said: “Kyowa Kirin is committed to improving outcomes for patients with rare diseases, whose needs are often underserved. It’s heartening to see this new real world data, which reinforces what we’ve seen previously in clinical trials. Kyowa Kirin is dedicated to improve the lives of patients with CTCL, which is a chronic, debilitating disease and to deliver on our purpose, to make people smile.”

MF and SS are subtypes of CTCL, a rare type of non-Hodgkin's lymphoma that can affect the skin, blood, lymph nodes and internal organs.3 It is associated with disfiguring skin lesions, intractable itching, sleep disturbance, and psychosocial problems, CTCL has a serious negative effect on quality of life.4

The new data was presented at a poster session at the EORTC meeting in Marseille, France, which is being held on 14-16 October 2021.

a The comparator in the MAVORIC trial was vorinostat, a histone deacetylase inhibitor (HDACi) and FDA-approved standard of care option for treatment of CTCL that is licensed in the US for the treatment of cutaneous manifestations in patients with CTCL who have progressive, persistent or recurrent disease on or following two systemic therapies. Vorinostat is not licensed for use in Europe.

b MAVORIC ORR included only those patients with confirmed global response at two (or more) successive evaluations at least 8 weeks apart).

About Mycosis Fungoides (MF) and Sézary syndrome (SS)

Cutaneous T-cell lymphoma (CTCL) is a cancer of white blood cells (lymphocytes) that presents in the skin.5 CTCLs are rare, serious and potentially life-threatening forms of non-Hodgkin lymphoma (NHL).2 Malignant T cells in CTCL circulate in the blood and migrate to the skin6 causing lesions and itching.7

The annual incidence of CTCL in Europe is around 5.2 new cases per 100,000 population8 and it affects around 240 people per million in the region at any one time.5 The two best-studied types of CTCL are mycosis fungoides (MF) and Sézary syndrome (SS).9 Together, MF and SS account for around two thirds of all CTCLs.10,11

  • MF accounts for approximately 60% of all CTCLs,10 is typically indolent and is characterised by skin symptoms including patches or plaques, skin redness and tumours.12
  • SS is much rarer, accounting for around 5% of CTCLs,6 and is more aggressive13 with high levels of blood involvement by definition.10 It causes very severe itching, total body redness (erythroderma), intense scaling of the skin and frequent hair loss. 7

It can typically take between three and six years from CTCL disease onset for a patient to be diagnosed, in some cases it can take decades.10,12 This is sometimes due to the fact that CTCL presents very similarly to other benign skin conditions (e.g. eczema and psoriasis)7; this can mean many patients experience a long, frustrating journey before diagnosis.

CTCL can be very distressing for patients and has a significant negative life-long impact upon many aspects of a patient’s life.12,14 CTCL causes chronic skin impairment with itching, pain, recurrent infections, and disfiguring skin lesions, as well as sleep disturbance and psychosocial problems.9,12 Even in the early stages of CTCL, the disease can affect patients’ ability to meet the needs of their family, interfere with their job, and limit normal daily activities.14

About POTELIGEO(mogamulizumab) and the MAVORIC Trial

Malignant T lymphocytes in MF and SS, consistently express a molecule called CC chemokine receptor 4 (CCR4).2 POTELIGEO is a humanised monoclonal antibody that selectively binds to CCR4-expressing cells15 and helps destroy them by harnessing the body’s immune system.2 POTELIGEO is a systemic therapy, administered by intravenous infusion weekly for the first five weeks, then subsequently every two weeks.15 The registrational Phase 3 MAVORIC trial was the largest randomised study of systemic therapy in CTCL. It evaluated the safety and efficacy of POTELIGEO versus vorinostat in patients who had failed at least one previous systemic therapy.2

Following a positive opinion from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the European Commission (EC) granted marketing authorisation for POTELIGEO in November 2018 for the treatment of adult patients with MF or SS who have received at least one prior systemic therapy.15

Important Prescribing information and Safety Information

Refer to the full Summary of Product Characteristics (SmPC) for prescribing information and the full safety information: https://www.ema.europa.eu/en/medicines/human/EPAR/poteligeo#product-information-section

About Kyowa Kirin

Kyowa Kirin strives to create and deliver novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company with a heritage of 70+ -years, we apply cutting-edge science including an expertise in antibody research and engineering, to address the needs of patients and society across multiple therapeutic areas including Nephrology, Oncology, Immunology/Allergy and Neurology. Across our four regions – Japan, Asia Pacific, North America and EMEA/International – we focus on our purpose, to make people smile, and are united by our shared values of commitment to life, teamwork/Wa, innovation, and integrity. You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.com/

Kyowa Kirin International

http://www.international.kyowa-kirin.com / www.kyowakirin.com

Galabank Business Park
Galashiels, TD1 1QH
United Kingdom

References

1 Bagot, M et al. Poster presentation at EORTC, 14-16 October 2021.

2 Kim YH, et al. Lancet Oncol. 2018;19(9):1192–1204.

3 Olsen E, Vonderheid E, Pimpinelli N, et al. Blood. 2007;110(6):1713-22.

4 EHA 2021 abstract. Available at: HEALTH-RELATED QUALITY OF LIFE EFFECT OF MOGAMULIZUMAB BY PATIENT.... EHA Library. Bishton M. Jun 9 2021; 324119 (ehaweb.org). Accessed October 2021

5 Willemze R, et al. Blood. 2019;133(16):1703–1714

6 Girardi M, Heald PW, Wilson LD. N Engl Jnl Med. 2004; 350(19): 1978-1988

7 Demierre M, et al. Cancer. 2006;107(10):2504–2511

8 Orphanet. Prevalence and incidence of rare diseases: Bibliographic data. January 2021. Available at: https://www.orpha.net/orphacom/cahiers/docs/GB/Prevalence_of_rare_diseases_by_alphabetical_list.pdf. Accessed: October 2021.

9 Krejsgaard T, et al. Semin Immunopathol. 2017;39:269–282.

10 Wilcox R. Am J Hematol. 2016;91(1):151-165.

11 Trautinger F, et al. Eur J Cancer. 2017;77:57–74.

12 Scarisbrick J, et al. Br J Dermatol. 2019;181(2):350–357.

13 Lymphoma Coalition. Cutaneous lymphoma – a patient’s guide. Available at: https://lymphomacoalition.org/wp-content/uploads/Cutaneous_lymphoma_-_patients_guide_-.pdf. Accessed October 2021

14 Hirstov AC, Tejavsi T, Wilcox RA. Am J Hematol. 2019;(734):ajh.25577

15 POTELIGEO SMPC. Available at: https://www.ema.europa.eu/en/documents/product-information/poteligeo-epar-product-information_en.pdf. Accessed October 2021

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Contacts for Kyowa Kirin International:
Media
Stacey Minton
+44 (0) 7769 656073
Email: Stacey.Minton@kyowakirin.com

About Business Wire

Business Wire
Business Wire



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

ExOne Showcases Ability to 3D Print Virtually Any Powder Material in New Corporate Video, “Let’s Make it Right”20.10.2021 14:30:00 CEST | Press release

The ExOne Company (Nasdaq: XONE), the global leader in industrial sand and metal 3D printers using binder jetting technology, today announced that it is open to developing virtually any powder material in partnership with manufacturers for their specific application. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211020005203/en/ The ExOne Company has released a new corporate video, "Let's Make it Right," showcasing the ability of its sustainable binder jetting technology to 3D print virtually any type of powder. ExOne has already qualified more than 20 metals, ceramics and composites for 3D printing, but is now developing materials such as pulverized concrete and other waste products with customers. (Photo: Business Wire) The material flexibility and sustainability of ExOne’s patented binder jet 3D printing technology is showcased in a new corporate video unveiled today, “Let’s Make it Right.” The video is a celebration of

Workiva Announces 2021 Partner of the Year Award Winners20.10.2021 14:00:00 CEST | Press release

Workiva Inc. (NYSE:WK), the company that simplifies complex work, announced the winners of the 2021 Workiva Partner of the Year Awards. The awards recognize partners that have leveraged their significant industry and solution-specific experience to help customers expand their use of the Workiva platform to drive transparency in reporting and compliance. Award recipients were recognized during the Company’s virtual Global Partner Summit, held October 18 & 19. “Our partners are instrumental in deploying the Workiva platform as a critical component in digital transformations across global enterprises,” said Corey Wells, vice president of partnerships and alliances at Workiva. “It’s an honor to recognize this year’s winners for helping drive the innovation and collaboration that has made a lasting impact on our customers' business.” 2021 Partner of the Year Award Winners Global Partner of the Year - DeloitteGlobal Technology Partner of the Year - FloQastNorth American Advisory Partner of t

BentallGreenOak Achieves New High Mark for Exceptional Performance in the 2021 Global Real Estate Sustainability Benchmark (GRESB), Marking 11 Consecutive Years of Excellence and Industry Leadership in ESG20.10.2021 14:00:00 CEST | Press release

BentallGreenOak (BGO) announced today that, in a consecutive run of industry leadership now marking 11 years, its global real estate investment platform has achieved a new high mark for exceptional performance in the annual Global Real Estate Sustainability Benchmark (GRESB). Four of BGO’s flagship investment strategies, already amongst the best performing funds in their global categories, achieved five star ratings and higher scores in 2021, reinforcing a firm-wide commitment to enhanced, year-over-year performance in ESG across its platform. For the first time in BGO’s 11 years of GRESB participation, all BGO funds participating in the Development module — which measures an entity’s efforts to address ESG issues during a building’s design, construction and renovation phases — ranked first in their peer group, achieving Sector Leader status. Highlights from BentallGreenOak’s 2021 GRESB scores: All BGO Funds scored 100% on the Management component of GRESB, demonstrating leadership in

Slate Asset Management Expands European Platform with NOK 1 Billion Essential Real Estate Portfolio Acquisition in Norway20.10.2021 13:23:00 CEST | Press release

Slate Asset Management ("Slate”), a global alternative investment platform focused on real estate, announced today the acquisition of a portfolio of 25 essential real estate assets in Norway for approximately NOK 1 billion. The acquisition – Slate’s first in the Nordics – further scales the firm’s European platform and significantly increases Slate’s exposure to high-quality essential real estate assets in broader Europe. The portfolio comprises approximately 50,000 square meters geographically dispersed across Norway, with the majority concentrated in and around Norway’s five largest cities. The entirety of the portfolio’s income is generated by essential goods and service providers, including 24 grocery stores let to class-A tenants and one government-tenanted medical facility. The portfolio’s three major operators are leading Norwegian grocery groups Coop Norge, Reitan Group and NorgesGruppen, which hold around 96% of the total grocery market share in Norway. “We are actively increa

Israeli Food Manufacturer Tnuva Selects DXC Technology to Transform Supply Chain20.10.2021 13:00:00 CEST | Press release

DXC Technology (NYSE: DXC) today announced that it has been awarded one of Israel’s largest ever commercial IT implementation contracts, worth US$40 million, by Tnuva, Israel’s leading producer of dairy and food products. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211020005292/en/ Tnuva’s dairy production line (credit: Tnuva) Under the terms of the five-year agreement, DXC will modernize Tnuva’s IT estate by implementing a new digital supply chain system, which will help the food producer to accelerate operations and provide high quality food to millions of consumers across Israel. DXC will implement a single Enterprise Resource Planning (ERP) solution, based on SAP’s innovative ERP platform SAP S4/HANA®, to consolidate and modernize approximately 240 of Tnuva’s legacy systems across business applications and dairy management. The system will enable Tnuva to shorten the time to market for new products and optimize its da

EngageSmart to Announce Third Quarter 2021 Financial Results on November 10, 202120.10.2021 12:55:00 CEST | Press release

EngageSmart, Inc. (NYSE: ESMT), a leading provider of vertically-tailored customer engagement software and integrated payments solutions, will report third quarter 2021 financial results after the close of the market on Wednesday, November 10, 2021. Management will host a conference call to discuss the results at 5:00 p.m. ET. The conference call will be webcast live on EngageSmart’s investor relations website at https://investors.engagesmart.com/events-and-presentations/events./. A replay will be available on the investor relations website following the call. For investors and analysts wishing to participate in the call, the dial-in numbers are (844) 200-6205 for domestic callers and (929) 526-1599 for international callers. The conference call access code is 867326. About EngageSmart EngageSmart is a leading provider of vertically-tailored customer engagement software and integrated payments solutions. At EngageSmart, our mission is to simplify customer and client engagement to allow

Hogan Lovells White Paper Calls for Flexibility as the EU Establishes Its First-ever Regulatory Framework Enabling the Launch of Autonomous Vehicles20.10.2021 12:50:00 CEST | Press release

Global law firm Hogan Lovells has today shared its recommendations on the future of Europe’s regulatory framework for autonomous vehicles (AVs), as the European Commission takes an important first step in submitting a Draft EU ADS Regulation to all 27 Member States ahead of a Public Consultation in November. The regulatory framework published in late September 2021 will be used to help shape the future of AVs across the EU and will have far reaching implications on the AV industry in Europe for years to come. The Draft EU ADS Regulation sets out the type-approval rules for AVs with regard to their automated driving system (ADS) to create a harmonised pathway for (SAE/ISO) “Level 4” or “fully automated” vehicles to be deployed on public roads across Member States – with no human driver. It also establishes aggregate safety metrics that will be used to benchmark performance, and ultimately will be used as a measurement for allowing AV testing and deployment. The Hogan Lovells White Paper

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