UK—Kyowa Kirin International (KKI), a global speciality pharmaceutical company, has announced that it will present interim findings from three real-world studies evaluating mogamulizumab, a pioneering humanised monoclonal antibody therapy, in patients with cutaneous T-cell lymphoma (CTCL).

The studies will be presented at the European Organisation for Research and Treatment of Cancer’s Cutaneous Lymphoma Tumour Group (EORTC-CLTG) annual meeting, which has been taking place in Lausanne, Switzerland, from October 9th to 11th, 2024.

Mogamulizumab is approved in Europe and the United Arab Emirates for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.

In the United States and Switzerland, it is approved for the treatment of adult patients with relapsed or refractory MF or SS who have received at least one prior systemic therapy.  

The three studies, MINT (Germany), MIBERIC (Spain and Portugal), and PROSPER (US, UAE, Spain, Italy, Netherlands, UK), were designed to collect real-world evidence on the effectiveness and tolerability of mogamulizumab in patients with CTCL.

The MINT and MIBERIC studies focused on assessing the drug’s performance in real-world clinical settings, while the PROSPER study investigated its impact on patients from a patient-centered perspective.

Interim analyses from the MINT and MIBERIC studies showed that mogamulizumab was generally well-tolerated and demonstrated efficacy comparable to that observed in previous clinical trials. No new safety signals were identified in either study.

The PROSPER study evaluates the impact of mogamulizumab on patients’ symptoms, health-related quality of life, and the effect on their primary caregivers.

Patients receiving mogamulizumab reported improvements in skin symptoms, such as pain, itch, flaking, and redness, as well as improvements in sleep, body temperature regulation, and fatigue.

 These improvements led to enhanced health-related quality of life within 24 weeks of treatment.

During the meeting, Professor Emmanuella Guenova, chief physician of dermatology and venereology at Lausanne University Hospital and chair of the EORTC-CLTG 2024 Annual Meeting, emphasized that the goal of CTCL treatment for most patients is to delay disease progression, alleviate symptoms, and maintain or improve their quality of life.

She further noted that the real-world evidence generated by Kyowa Kirin is vital for physicians to understand how patients respond to treatment outside of controlled trials, helping them make more informed decisions.

Additionally, Dr. Nicholas Kronfeld, Senior Vice President and Head of Medical Affairs at Kyowa Kirin International, highlighted the significance of these studies.

He mentioned that the findings build on last year’s presentations and reaffirm the company’s commitment to delivering a broad spectrum of real-world data to guide clinical decision-making and improve patient outcomes.

Dr. Kronfeld also highlighted that their ongoing research into CTCL continues to demonstrate the clinical versatility of mogamulizumab across different patient profiles and healthcare systems.

As part of their commitment to sharing scientific knowledge, Kyowa Kirin will present three abstracts at EORTC-CLTG 2024.

Professor Chalid Assaf from Helios Hospital in Germany will present the MINT study; Professor Pablo Ortiz Romero from Hospital Universitario 12 de Octubre in Spain will present the MIBERIC study; and Professor Julia Scarisbrick from University Hospital Birmingham in the United Kingdom will present the PROSPER study.

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