Kyowa Kirin International: New Real World Evidence Underlines Benefits of POTELIGEO®▼ (mogamulizumab) Treatment for Cutaneous T-cell Lymphoma (CTCL) Patients
Patients responded better to treatment with POTELIGEO in real life, compared to data from the pivotal Phase 3 MAVORIC trial1
Data was collected and analysed from medical records of 124 MF and SS patients treated with POTELIGEO between
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
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
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
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
- 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
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
1 Bagot, M et al. Poster presentation at EORTC,
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....
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.
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
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
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