Kyowa Kirin Announces Positive Interim Real-world Data for Mogamulizumab (Poteligeo®) in Cutaneous T-cell Lymphoma at EORTC-CLTG 2024
Interim real-world data reinforces effectiveness and tolerability of mogamulizumab for mycosis fungoides (MF) or Sézary Syndrome (SS) in routine clinical practice
GALASHIELS & MARLOW,
The three studies include participants from
“For most patients, treatment of CTCL aims to prolong time to disease progression, reduce the burden of disease and preserve or enhance quality of life,” said Professor
This will be the second interim analyses from these studies:
-
MINT (
Germany ) and MIBERIC (Spain andPortugal ) – study the effectiveness and tolerability of mogamulizumab in real-world clinical practices and are broadly in line with efficacy and safety data demonstrated in global clinical trials. Across both studies, no new safety signals were seen. -
PROSPER (US,
UAE ,Spain ,Italy ,Netherlands ,UK ) – 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. Patients receiving mogamulizumab experienced improvements in skin symptoms (pain, itch, flaking and redness), sleep problems and body temperature within four weeks and improvements in patient-reported fatigue and health-related quality of life within 24 weeks.
“The studies being presented at EORTC-CLTG build on our presentations at last year’s annual meeting and reinforce our commitment to providing the community with a wide breadth of real-world data to inform clinical decision-making and hopefully improve patient outcomes,” said Dr
Table 1. Overview of
Trial |
Presenting author |
Abstract Title |
Timing |
MINT (oral)
|
Prof.
|
Mogamulizumab in patients with mycosis fungoides or Sézary syndrome: Update on the German non-interventional MINT study
|
18:30–19:30, |
MIBERIC (oral)
|
Prof.
|
Real-world effectiveness of mogamulizumab in MIBERIC study
|
18:30–19:30, |
PROSPER (oral)
|
Prof.
|
Patient-reported symptoms and HRQL of MF and SS patients receiving mogamulizumab over 24 weeks: interim results from the PROSPER study
|
15:25–16:25, |
About Poteligeo® (mogamulizumab)
Mogamulizumab is a first-in-class humanised monoclonal antibody directed against CC-chemokine receptor 4 (CCR4), a protein consistently expressed on cancerous cells seen in both MF and SS.4-6 Once mogamulizumab binds to CCR4, it increases attraction of immune cells from the immune system to destroy the cancerous cells.7
About MF and SS
MF and SS are two subtypes of CTCL,8 which is itself a rare form of non-Hodgkin’s lymphoma that presents and persists in the skin.9,10 CTCL is treatable, but is not generally considered to be curable, and there has been a clear unmet need for novel treatment options. As well as the obvious impact of symptoms upon patients, there can be significant erosions to quality of life for those caring for an individual living with CTCL.11
MF and SS are characterised by localisation of cancerous white blood cells called T lymphocytes (T cells), to the skin.12,13 These cancerous T cells consistently express a protein called CCR4, which enables them to move from the blood to the skin.4-6 When these cancerous T cells move to the skin, this results in the visible early skin symptoms of red patches or plaques which can resemble psoriasis or eczema in the early stages of the disease.4,12,14-17 Later, for some patients, skin involvement may evolve to include tumours or reddening of the majority of the skin’s surface (erythroderma).
MF—the most common CTCL subtype—accounts for approximately 60% of all CTCLs and is typically indolent,10 characterised by skin symptoms including patches or plaques, skin redness and tumours.18 SS is much rarer, accounting for around 5% of CTCLs,19 and is more aggressive,12 with high levels of blood involvement.20 It can cause severe itching, erythroderma, intense scaling of the skin and frequent hair loss.14,21 CTCL can take on average, between 2 and 7 years for individuals to receive a confirmed diagnosis.22
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References |
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3
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4 Ferenczi K, et al. Increased CCR4 expression in cutaneous T cell lymphoma. J Invest Dermatol. 2002;119:1405-10. |
5 Yoshie O, et al. Frequent Expression of CCR4 in Adult T-Cell Leukemia and Human T-cell Leukemia Virus Type 1-transformed T cells. Blood. 2002;99(5):1505-11. |
6 Ishida T, et al. Clinical Significance of CCR4 Expression in Adult T-cell Leukemia/Lymphoma: Its Close Association With Skin Involvement and Unfavorable Outcome. |
7 Duvic M, et al. Mogamulizumab for the treatment of cutaneous T-cell lymphoma: recent advances and clinical potential. Ther Adv Hematol. 2016;7(3):171-174. |
8 Kim YH, Bagot M, Pinter-Brown L, et al. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2018;19(9):1192-1204. |
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10 Willemze R, et al. The 2018 update of the WHO-EORTC classification for primary cutaneous lymphomas. Blood. 2019;133(16):1703-1714. |
11 Williams et al (2020) – Health state utilities associated with caring for an individual with CTCL. |
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13 Mariani M, Lang R, Binda E, et al. Dominance of CCL22 over CCL17 in induction of chemokine receptor CCR4 desensitization and internalization on human Th2 cells. Eur J Immunol. 2004;34(1):231-240. |
14 Wilcox RA. Cutaneous T-cell lymphoma: 2016 update on diagnosis, risk-stratification, and management. Am J Hematol. 2016;91(1):151-65. |
15 Ni X, Jorgensen JL, Goswami M, et al. Reduction of regulatory T cells by Mogamulizumab, a defucosylated anti-CC chemokine receptor 4 antibody, in patients with aggressive/refractory mycosis fungoides and Sézary syndrome. |
16 Kakinuma T, Sugaya M, Nakamura K, et al. Thymus and activation-regulated chemokine (TARC/CCL17) in mycosis fungoides: serum TARC levels reflect the disease activity of mycosis fungoides. J Am Acad Dermatol. 2003;48(1):23-30. |
17 Girardi M, Heald PW, Wilson LD. The Pathogenesis of Mycosis Fungoides. NEJM. 2004;350(19):1978-88. |
18 Scarisbrick, J, et al. The PROCLIPI international registry of early-stage mycosis fungoides identifies substantial diagnostic delay in most patients. Br |
19 Trautinger F, et al. |
20 Scarisbrick JJ, Whittaker, S, Evans, AV, et al. Prognostic significance of tumor burden in the blood of patients with erythrodermic primary cutaneous T-cell lymphoma. Blood. 2001;97(3):624-30. |
21 Demierre M-F, et al. Significant impact of cutaneous T-cell lymphoma on patients' quality of life. Cancer. 2006;107(10):2504-2511. |
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