Kyowa Kirin Presents New Data on Response to Treatment in Cutaneous T-cell Lymphoma (CTCL) Patients Who Have Blood Involvement
Results of data analysis from the MAVORIC trial could help improve clinical management of the disease, data presented today at the 16th
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 In MAVORIC, overall investigator-assessed progression-free survival (PFS) was significantly greater for patients treated with mogamulizumab compared to vorinostat, at 7.7 months and 3.1 months, respectively (P<0.0001).1 When data were stratified by blood classification, PFS was found to be significantly greater for mogamulizumab compared to vorinostat in patients with higher levels of blood involvement, known as B1 and B2 blood classifications.1
Overall response rate (ORR) was also significantly greater for mogamulizumab than vorinostat in the MAVORIC trial at 28% and 5% respectively (P<0.0001).1 In this analysis, ORR was also found to be significantly greater for mogamulizumab than vorinostat in patients with B2 blood classification.1 Difference in ORR for patients with B1 blood classification was not significant between the two treatment groups.1 Difference in time-to-next-treatment (TTNT) was not significant for patients without blood involvement (B0 classification), but was significantly greater for mogamulizumab in patients with B1 or B2 blood involvement, 13.70 vs 3.30 months for mogamulizumab and vorinostat, respectively (P<0.0001).1 Drug-related treatment-emergent adverse events (TEAEs) were similar in patients regardless of blood involvement and were lower for mogamulizumab than vorinostat at each blood classification level.1
The data will be presented today in a poster session at the 16th
About Mycosis Fungoides (MF) and Sézary syndrome (SS)
MF and SS are subtypes of cutaneous T-cell lymphoma (CTCL), a rare type of non-Hodgkin's lymphoma that can affect the skin, blood, lymph nodes and internal organs.2 CTCL is rare. For every 100,000 people in
MF and SS are characterised by localisation of cancerous white blood cells called T lymphocytes (T cells), to the skin.8,9 These cancerous T cells consistently express a protein called CC-chemokine receptor 4 (CCR4), which enables them to move from the blood to the skin.10,11,12 When these cancerous T cells move to the skin, they can create a localised inflammatory immune skin response, commonly resulting in visible skin symptoms of red patches or plaques, 10,13,14,15,16 which can resemble psoriasis or eczema.8
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 All four areas of the body are used to assess disease stage17,18 and clinically significant involvement of the blood, particularly in more advanced disease, is linked with increased morbidity and an overall reduction in patient survival.17,19,20
Due to its likeness to more common skin conditions such as eczema and psoriasis,8 CTCL can take, on average, between 2 and 7 years for individuals to receive a confirmed diagnosis.21 It is critical for doctors to diagnose CTCL as early as possible as the patient’s prognosis can be affected if the disease progresses to later stages.4 Whilst most individuals that present with early stage do not progress to a more advanced stage,22 patients with advanced disease have significantly poorer outcomes with only around half of patients (52%) surviving for just 5 years.17
POTELIGEO is a first-in-class humanised monoclonal antibody (mAb), designed to bind to CC chemokine receptor 4 (CCR4).7 After POTELIGEO binds to CCR4, it increases affinity of immune cells from the immune system to target the cancerous cells.23 POTELIGEO uses Kyowa Kirin’s proprietary POTELLIGENT® technology.23
Following a positive opinion from Committee for Medicinal Products for Human Use (CHMP) of the
About the MAVORIC Trial
- The MAVORIC trial is the largest randomised study of systemic therapy conducted in MF and SS,7 and the first trial to compare systemic therapies using ‘progression-free survival’ (PFS) as a primary endpoint, which incorporates looking at disease progression in four different compartments of the body (skin, blood, lymph nodes and internal organs).7
- Secondary endpoints were overall response rate; duration of response (time from first achievement of an overall response to progression or death); the proportion of patients with an overall response in the crossover portion of the trial; assessment of quality of life; immunogenicity (immune response) and safety.7
Results showed that:
- In patients taking POTELIGEO disease was controlled for more than twice as long as in those taking the comparator treatment, vorinostat* (PFS of 7.7 mths vs 3.1 mths) (HR=0.53, 95% CI: 0.41–0.69; p<0.0001).7
- Overall significantly more patients responded to POTELIGEO than vorinostat* (Overall Response Rate [ORR] 28% versus 5%; Risk Ratio [RR]: 23.1; 95% CI 12.8–33.1, P<0.0001).7
- Response to treatment lasted 43% longer in people taking POTELIGEO versus those taking vorinostat* (14.1 months versus 9.1 months).7
- More patients responded to POTELIGEO, across all studied MF/SS disease stages than with vorinostat.*7
- POTELIGEO has overall good tolerability with a manageable safety profile.7,25
- The most common adverse reactions with POTELIGEO are constipation, diarrhoea, nausea, stomatitis, fatigue, oedema (peripheral), pyrexia, infections, infusion related reactions, headache and drug eruption (including skin rash).24
*Vorinostat is a
Important Safety Information
Refer to the full Summary of Product Characteristics (SmPC) for full safety information: https://www.ema.europa.eu/en/medicines/human/EPAR/poteligeo#product-information-section
You can learn more about
1 Scarisbrick J, et al. Efficacy and Safety of Mogamulizumab by Patient Blood Classification. Abstract from 16
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
3 Scarisbrick JJ, Quaglino P,
4 Agar N, et al. Survival Outcomes and Prognostic Factors in Mycosis Fungoides/Sezary Syndrome: Validation of the
5 Orphanet: Prevalence and incidence of rare diseases: Bibliographic data. Available from: https://www.orpha.net/orphacom/cahiers/docs/GB/Prevalence_of_rare_diseases_by_decreasing_prevalence_or_cases.pdf. Last accessed:
6 Haun P, et al. Fast Facts: Diagnosing Cutaneous T-Cell Lymphoma.
7 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.
9 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.
10 Ferenczi K, Fuhlbrigge RC, Pinkus J, et al. Increased CCR4 expression in cutaneous T cell lymphoma. J Invest Dermatol. 2002;119:1405-10.
11 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.
12 Ishida T, et al. Clinical Significance of CCR4 Expression in Adult T-cell Leukemia/Lymphoma: Its Close Association With Skin Involvement and Unfavorable Outcome.
13 Wilcox RA. Cutaneous T-cell lymphoma: 2016 update on diagnosis, risk-stratification, and management. Am J Hematol. 2016;91(1):151-65.
14 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.
15 Kakinuma T, Sugaya M, Nakamura K, et al. Hymus 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.
16 Girardi M, Heald PW, Wilson LD. The Pathogenesis of Mycosis Fungoides. NEJM. 2004;350(19):1978-88.
17 Scarisbrick JJ,
18 Willemze R, Hodak E, Zinzani PL et al. Primary cutaneous lymphomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018;29(4):1-29.
19 Kim EJ, Hess S,
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.
22 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.
23 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.
24 POTELIGEO SMPC. Available from: https://www.ema.europa.eu/en/documents/product-information/poteligeo-epar-product-information_en.pdf Last accessed:
25 Kim YH, Bagot M, Zinzani PL et al. Safety of Mogamulizumab in Mycosis Fungoides and Sézary Syndrome: Final Results from the Phase 3 Mavoric Study. Blood. 2019;134 (1):5300.
+44 (0) 7769 656073
Contacts for Kyowa Kirin International:
+44 (0) 7769 656073