Systemic therapy approved for second-line treatment of adults with mycosis fungoides (MF) or Sézary syndrome (SS) demonstrates effectiveness in routine clinical practice.
TOKYO–(BUSINESS WIRE)–Kyowa Kirin International (KKI), a wholly owned subsidiary of Kyowa Kirin Co. Ltd, today announced the acceptance of an extensive programme of data to the annual meeting of the European Organisation for Research and Treatment of Cancer’s Cutaneous Lymphoma Tumour Group (EORTC-CLTG), taking place from the 21st – 23rd of September 2023 in Leiden, the Netherlands.
Four studies across a range of European countries, the USA and the UAE, aim to collect robust evidence in a real-world clinical setting for Poteligeo® (mogamulizumab), the first-in-class humanised monoclonal antibody (mAb) therapy approved in Europe for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.
Danie du Plessis, Executive Vice President of International Medical Affairs, Kyowa Kirin, commented: “The studies presented at EORTC-CLTG demonstrate our long-term commitment to expand the evidence base for the effectiveness of mogamulizumab in real-world settings. Our ongoing research programme in CTCL extends across a wide geographic area, recognising the patient perspective, clinical endpoints and the diversity of healthcare systems, all part of our ambition to improve outcomes for those affected by mycosis fungoides and Sézary syndrome.”
Data from OMEGA (France) represents the first published real-world evidence generated by KKI regarding the effectiveness of mogamulizumab. OMEGA, a completed, retrospective, real-world, non-interventional observational study, described real-world effectiveness and tolerability of mogamulizumab in patients with MF and SS.
Alongside the data from OMEGA, interim data from two of the other studies – MINT (Germany) and MIBERIC (Spain and Portugal) – support the effectiveness of mogamulizumab in real-world clinical practices and are in line with efficacy and safety data demonstrated in global clinical trials. Across all three trials no new safety signals were seen. The fourth study – PROSPER (USA, UAE, Spain, Italy, Netherlands, UK) – is an ongoing study investigating the impact of mogamulizumab in patients with MF and SS from the patient perspective assessing symptoms and health-related quality of life, as well as impact on their primary care partners, also in the real-world clinical setting.
Professor Chalid Assaf, Director of the Department of Dermatology, HELIOS Klinikum Krefeld, and lead author of the MINT study, commented: “CTCL can have a severely detrimental impact on patients’ health-related quality of life, with sometimes far-reaching consequences for those living with the disease as well as their families. The real-world evidence being generated by Kyowa Kirin raises the standard of information available to those involved in treating mycosis fungoides and Sézary syndrome helping to inform decisions that support optimal patient care.”
Table 1. Overview of mogamulizumab study programme for presentation at EORTC-CLTG
Trial Name and Presentation Type
Prof. Marie Beylot-Barry, Bordeaux Institute of Oncology, France
Efficacy and tolerability of mogamulizumab in patients with Mycosis Fungoides or Sézary syndrome. Retrospective and real-world data from centres of the French Study Group of Cutaneous Lymphoma
Prof. Chalid Assaf, Helios Hospital, Germany
Mogamulizumab in patients with mycosis fungoides or Sézary syndrome: Interim analysis of the German non-interventional MINT study
Prof. Pablo Ortiz Romero, Hospital Universitario 12 de Octubre, Spain
Real-world effectiveness of mogamulizumab in patients with Sézary syndrome or mycosis fungoides in Spain and Portugal: The MIBERIC study
Prof. Julia Scarisbrick, University Hospital Birmingham, United Kingdom
A Real-World International Observational Study of Mogamulizumab in Adult Patients with Mycosis Fungoides and Sézary Syndrome (PROSPER study NCT05455931) – UK
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Kyowa Kirin Co., Ltd.