Business Wire

Kyowa Kirin: New Data Analysis Shows Link between Blood Involvement and Response to Treatment in 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 analysis of data showing statistically significant improvements in quality of life in cutaneous T-cell lymphoma (CTCL) patients treated with mogamulizumab with blood involvement, compared to vorinostat.1 The new findings from the MAVORIC trial compared the impact of treatment with POTELIGEO® (mogamulizumab) and vorinostat by patient blood tumour burden in adult patients with mycosis fungoides (MF) and Sézary syndrome (SS), two types of CTCL.

Professor Doctor Pier Luigi Zinzani of the Institute of Hematology "L. e A. Seràgnoli" at the University of Bologna said: “This new analysis helps us to understand more about the importance of blood involvement in CTCL, which is relatively common in the more advanced stages of the disease and may be present in some less advanced cases. We know that increasing levels of malignant T-cells in the blood correlate with increased risk of CTCL disease progression and an overall reduction in patient survival. Treatment with mogamulizumab has also been shown to be more effective in CTCL patients who have blood involvement as part of their disease and treatment with mogamulizumab also generates quality of life benefits for CTCL patients with blood involvement. This new information underlines the importance of blood monitoring in the clinical management of CTCL patients.”

In the study, patients classified as B0 were considered to have no blood involvement and patients classified as B1 and B2 were considered to have blood involvement.1 B1 is a measurable low level of blood involvement of between 250 to 1000 abnormal T-cells per µL. B2 is higher level of blood involvement, greater than 1000 abnormal T-cells per µL, detected using flow cytometry.

Statistically significant differences in quality of life were seen for patients with blood involvement, with patients treated with mogamulizumab seeing improvements in the Skindex-29 and ItchyQoL questionnaires, compared to vorinostat. Quality of life improvements were also seen in patients treated with mogamulizumab with blood involvement assessed by the Pruritus Likert Scale and the FACT-G Total Score questionnaires, compared to vorinostat. For patients with no blood involvement there was no statistically significant differences in quality of life between mogamulizumab and vorinostat.1

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.2 As a chronic and generally incurable disease associated with disfiguring skin lesions, intractable itching, sleep disturbance, and psychosocial problems, CTCL has a serious negative effect on quality of life.1 MAVORIC is the largest multinational, randomised, Phase 3 trial of systemic CTCL therapy. MAVORIC evaluated the safety and efficacy of mogamulizumab versus vorinostat in patients who had received at least one previous systemic therapy.3 This new post hoc analysis of the MAVORIC trial looked at data from patients’ quality of life using a range of recognised and validated assessment tools.1

The MAVORIC trial met its primary endpoint of overall investigator-assessed progression-free survival (PFS), which was shown to be significantly greater for patients treated with mogamulizumab compared to vorinostat, at 7.7 months and 3.1 months, respectively (P<0.0001).3

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

Cutaneous T-cell lymphomas (CTCL) are rare, serious and potentially life-threatening, forms of non-Hodgkin’s lymphoma,2 affecting around 240 persons per 1,000,000 population across Europe.4 Mycosis fungoides (MF) and Sézary syndrome (SS) are the two best studied types of CTCL,5 together accounting for around two thirds of all CTCLs.6,7

MF and SS can affect the skin, blood, lymph nodes (part of the body’s immune system which is spread throughout the body) and internal organs.2 MF and SS can be very distressing for patients and have a significant negative impact upon many aspects of patients’ lives.3,8 Disease stage in MF and SS is the most important prognostic factor,9 and draws upon the type and extent of skin involvement, as well as the presence or absence of extracutaneous disease in lymph nodes, viscera, and blood.10 Hence, assessment of all four anatomical ‘compartments’ is recommended, first at diagnosis and then to assess patient response to treatment.10,11

Neoplastic T lymphocytes in MF and SS, consistently express CC chemokine receptor 4 (CCR4),3 making this a relevant target for treatment at all stages of disease. All disease stages can include blood involvement10,12 and blood tumour burden may be relevant for prognosis13 and treatment6,10,14,15 in MF and SS.

Due to its likeness to more common skin conditions such as eczema and psoriasis,16 CTCL can take, on average, between 2 and 7 years for individuals to receive a confirmed diagnosis.17 It is critical for doctors to accurately diagnose CTCL as early as possible as the patient’s prognosis can be affected if the disease progresses to later stages.13 Whilst most individuals that present with early stage do not progress to a more advanced stage,18 patients with advanced disease have significantly poorer outcomes with only around half of patients (52%) surviving for just 5 years.19

About POTELIGEO(mogamulizumab) and the MAVORIC Trial

POTELIGEO (mogamulizumab), a humanised monoclonal antibody that selectively binds to CCR4,20 elicits anti-tumour activity by antibody-dependent cellular cytotoxicity (ADCC).3

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 mogamulizumab in November 2018 for the treatment of adult patients with MF or SS who have received at least one prior systemic therapy.20 The CHMP’s opinion was based on results of the MAVORIC trial, the largest randomised study of systemic therapy in MF and SS,3 and the first trial to compare systemic therapies using progression-free survival as a primary endpoint.3

MAVORIC evaluated the safety and efficacy of mogamulizumab versus vorinostat in patients who had received at least one previous systemic therapy:3

  • Mogamulizumabmore than doubled median progression-free survival (PFS) in patients with relapsed or refractory MF/SS, compared with vorinostat (7.7 months vs 3.1 months), which is a relative reduction in the risk of disease progression of 47% (HR=0.53, 95% CI: 0.41–0.69; P<0.0001). 3
  • Overall, significantly more patients responded to mogamulizumab than vorinostat (overall response rate [ORR] 28.0% versus 4.8% (P<0.0001). 3
  • Median time-to-next-treatment (TTNT), an additional measure of clinical benefit and disease control, was significantly superior in patients treated with mogamulizumab compared to those that received vorinostat (11.0 months vs 3.5 months; P<0.0001). 3
  • In post hoc analyses, patients with B1 and B2 levels of blood tumour burden that received mogamulizumab have been shown to draw significantly more benefit in terms of PFS,21 TTNT, 21 and improvement in mSWAT22 compared to patients that received vorinostat.
  • Mogamulizumab shows good tolerability with a manageable safety profile. 3,23,24,25

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 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 June 2021

2 Olsen E, Vonderheid E, Pimpinelli N, et al. Revisions to the staging and classification of mycosis fungoides and Sezary syndrome: a proposal of the International Society for Cutaneous Lymphomas (ISCL) and the cutaneous lymphoma task force of the European Organization of Research and Treatment of Cancer (EORTC). Blood. 2007;110(6):1713-22.

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

4 Orphanet. Prevalence and incidence of rare diseases: Bibliographic data. January 2020. Accessed December 2020.

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

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

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

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

9 Hughes CF, et al. Australas J Dermatol. 2016;57(3):182–191.

10 Olsen EA, et al. J Clin Oncol. 2011;29(18):2598–2607.

11 Scarisbrick, J. EMJ Hematology. 2018;6(1):92–100.

12 Scarisbrick J, et al. Eur J Cancer. 2018;93:47–56.

13 Agar N, et al. J Clin Oncol. 2010;28(31):4730–4739

14 Willemze R, et al. Ann Oncol. 2018;29(4):iv30-iv40.

15 National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Primary Cutaneous Lymphomas (Version 1.2021 – October 12, 2020)

16 Scarisbrick J, at al, J Clin Oncol 2015;33(32):3766-3773

17 CL Foundation: A Patient’s Guide. Available from: https://www.clfoundation.org/sites/default/files/2018-04/a_patients_guide.pdf. Last Accessed: September 2020

18 Krejsgaard T, Lindahl LM, Mongan NP, et al. Malignant inflammation in cutaneous T-cell lymphoma—a hostile takeover. Semin Immunopathol. 2017;39(3):269–282.

19 KIM YH, et al. Blood 2019; 134(1):269-282

20 POTELIGEO® (mogamulizumab) Summary of Product Characteristics.

21 Scarisbrick J, et al. Efficacy and Safety of Mogamulizumab by Patient Blood Classification. Poster presented at: European Association of Dermato Oncology (EADO); 12–14 October, 2020. Vilnius, Lithuania.

22 Quaglino P, et al. he Correlation Between Skin Response and Blood Involvement with Mogamulizumab. Poster presented at: European Association of Dermato Oncology (EADO); 12–14 October, 2020. Vilnius, Lithuania.

23 Duvic M, et al. Blood. 2015;125(12):1883–1889

24 Ogura M, et al. J Clin Oncol. 2014;32(11):1157–1163

25 Yamamoto K, et al. J Clin Oncol. 2010;28(9):1591–1598

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
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

BourseInside, The New Media Platform That Finds Attractive Investments for Curious Investors22.6.2021 17:08:00 CEST | Press release

On the stock market, small caps continue to outperform. Since 1926, they have posted a performance of 12.1% per year, in contrast to 9.7% for large caps. And yet these so-called "small stocks" have been largely ignored by the stock market. They are rarely covered by analysts, shunned by the mainstream stock-market press and neglected by funds. Nevertheless, they are of great interest to investors, in particular those who have recently taken to investing in the stock market in order to grow their savings (16% increase in investors in 2020). For half of these newcomers, investing in the stock market gives them the opportunity to support the French economy by supporting the growth of our future champions and to channel their savings into a more sustainable and fairer model. In order to further strengthen this link between the French people and the development of our national companies, we decided to create BourseInside, the first web/TV/newsletter media platform, fully dedicated to listed

DARZALEX®▼ (daratumumab) Subcutaneous (SC) Formulation Becomes the First Approved Treatment for Newly Diagnosed Systemic Light Chain Amyloidosis in Europe and Gains an Additional Approval in Pre-Treated Multiple Myeloma22.6.2021 16:31:00 CEST | Press release

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the European Commission (EC) has granted marketing authorisation for the expanded use of DARZALEX®▼ (daratumumab) subcutaneous (SC) formulation in two new indications. The first authorisation of these new indications is for the use of daratumumab SC in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adults with newly diagnosed systemic light chain (AL) amyloidosis. This approval makes this daratumumab-based regimen the first approved therapy for AL amyloidosis in Europe. The second authorisation is for the use of daratumumab SC in combination with pomalidomide and dexamethasone (D-Pd) for the treatment of adults with multiple myeloma (MM) who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor, and have

PPG Introduces Digital Color-Matching Device for Commercial Vehicles22.6.2021 15:02:00 CEST | Press release

PPG (NYSE: PPG) today announced the introduction of its ColorReader portable digital device, which will enable customers in the commercial vehicle sector to quickly and precisely match colors to the PPG DELFLEET ONE® color palette and international standard colors. ColorReader is a BLUETOOTH®-connected device that works with a dedicated app. Available for iOS and Android tablets and smartphones, the device provides a highly accurate color match in just a few seconds. “All users have to do is download the ColorReader app, connect with their smartphone or tablet, and place ColorReader on the painted surface to scan,” said Jo Thompson, PPG color marketing manager, automotive refinish, Europe, Middle East and Africa. “ColorReader also offers a smart solution when a smartphone or tablet is not available by instantly displaying the three closest matching colors on its built-in display after scanning.” PPG recently launched ColorReader in Europe, the Middle East and Africa, and has received a

Personalis Announces NeXT Level Biomarkers Symposium22.6.2021 15:01:00 CEST | Press release

Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, today announced its inaugural event, NeXT Level Biomarkers Symposium, which will showcase novel research into emerging biomarkers using the Personalis NeXT Platform™. This event will detail the latest research from Personalis as well as a case study done in collaboration with the Parker Institute for Cancer Immunotherapy. Presentations from Personalis will focus on recently published research into HLA loss of heterozygosity, neoantigen prediction, as well as Personalis’ novel composite biomarker, the Neoantigen Presentation Score (NEOPS™). In addition, Dr. Theresa LaVallee will be presenting findings from the PRINCE trial based on data developed and analyzed in collaboration with Personalis. The agenda for NeXT Level Biomarkers Symposium will cover: Biomarker Discovery with ImmunoID NeXT Platform® Exploring HLA LOH with the DASH (Deletion of Allele-Specific HLAs) Algorithm Neoantigen Binding Prediction and Bioma

Kymeta Joins the U.S. Army’s Armored Brigade Combat Team Pilot Program22.6.2021 15:00:00 CEST | Press release

Kymeta (www.kymetacorp.com), the communications company making mobile global, announced today that it has been selected to participate in the U.S. Army’s Armored Brigade Combat Team (ABCT) satellite communications on the move (SOTM) pilot program. The program will assess communications solutions on select vehicles to enhance battlefield network and command post communications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210622005288/en/ The Kymeta u8 is the comprehensive connectivity solution that is available today and enables trusted, secure communications on the go and on the pause with a host of innovative features. (Photo: Business Wire) The ABCT pilot program will be led by General Dynamics Mission Systems, and Kymeta will supply eight u8 terminals for integration and testing on a variety of ABCT vehicles. Kymeta is the world’s first and only metamaterial-based SOTM terminal, and its electronically steered flat pane

Anna Biosciences Launches Pioneering Immunotherapeutic Treatment to Fight COVID-1922.6.2021 15:00:00 CEST | Press release

Anna Biosciences, a drug discovery company focused on novel therapies in immuno-oncology, virology, and neurodegenerative diseases, today announces its entry in the fight against COVID-19 with the introduction of its immunotherapy platform, Syntem. The Anna Biosciences Syntem Platform deploys engineered proprietary molecules to create synthetic immunity. Syntem’s lab-made molecules are multi-specific: they first target and flag the pathology, and then elicit an immune reaction that targets the virus or disease. Research indicates the Syntem Platform can inhibit viral infection and aid in the removal of COVID-19 infected cells. Showing promise as both a prophylactic and a treatment, there is considerable hope that in addition to supporting the broader population, immunocompromised patients will be able to safely use Syntem to prevent infection. Importantly, Syntem also exhibits high potential against COVID variants. In the case of COVID-19, and coronaviruses more generally, the Syntem P

National Arena Bucharest Completes Fast-Paced Addition of LED Stadium Lighting for UEFA EURO 202022.6.2021 15:00:00 CEST | Press release

In preparation to host UEFA EURO 2020, National Arena Bucharest has been fitted with a state-of-the-art LED lighting system – a project that was designed, shipped, and installed in just two months. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210622005161/en/ National Arena Bucharest Completes Fast-Paced Addition of LED Stadium Lighting for UEFA EURO 2020 (Photo: Business Wire) The new LED lighting was installed to augment the stadium’s existing metal halide lights, in order to meet television broadcast standards set for by UEFA for the global event. The new lighting was designed and engineered by Musco, utilizing its Total Light Control—TLC for LED™ system. “We are now sure that we will have a spectacular EURO,” said Florin Sari, Leader Local Organizing Structure EURO 2020 Bucharest. “The win will be a stadium that will be able to host any kind of top competition from now on also.” Equally impressive as the new system’s t