Higher blood burden was associated with a greater reduction in skin involvement for POTELIGEO1,a-c
- Best overall skin response is represented by the maximum percentage change in skin mSWAT score2
- In the POTELIGEO treatment arm, 81 patients (43.5%; B0, n=16; B1, n=14; and B2, n=51) had a best overall response of at least a 50% change in mSWAT score compared with 41 vorinostat treated patients (22.0%; B0, n=14; B1, n=5; and B2, n=22)
- By Cycle 6, patients treated with POTELIGEO experienced at least a 30% response in skin across all blood classifications
<15% CD4+CD26- or CD4+CD7- cells by flow cytometry
- ≥15% CD4+CD26- or CD4+CD7- cells by flow cytometry
≥1000/μL Sézary cells with positive clone, CD4:CD8 ratio ≥10, 40% CD4+CD7- cells, or ≥30% CD4+CD26- cells
- aSkin response was measured based on a post hoc analysis; a finding from the post hoc analysis cannot be used to demonstrate differences between treatments and may not be applicable to all patients initiating POTELIGEO.
- bSkin response was evaluated using the modified Severity Weighted Assessment Tool (mSWAT) based on visual inspection of the skin.3
- cmSWAT is calculated as the sum of body surface area of each body region multiplied by a weighting factor for the type of lesion mSWAT score = (Subtotal BSA Patch X 1) + (Subtotal BSA PLAQUE X 2) + (Subtotal BSA TUMOR X 4).4
mSWAT is used for calculating cutaneous involvement in patients with mycosis fungoides (MF) and Sézary syndrome (SS)5
- Routine evaluation for MF and SS patients includes a formal estimation of skin tumor burden using mSWAT that measures the total body surface area (BSA) by using the patient’s palm and fingers to represent 1% BSA
- Patch, plaque, and tumor BSA are determined separately and multiplied by a factor (1, 2, and 4, respectively) to generate the standardized mSWAT score
mSWAT is calculated as the sum of BSA of each body region multiplied by a weighting factor for the type of lesion; mSWAT
score = (Subtotal BSA Patch x 1) + (Subtotal BSA Plaque x 2) + (Subtotal BSA Tumor x 4)4
Patch=any size lesion without induration or significant elevation above the surrounding uninvolved skin; poikiloderma may be present. Plaque=any size lesion that is elevated or indurated; crusting or poikiloderma may be present. Tumor=any solid or nodular lesion ≥1 cm in diameter with evidence of deep infiltration in the skin and/or vertical growth.4
POTELIGEO was evaluated in the largest randomized, open-label, phase 3 trial of a systemic therapy for patients with mycosis fungoides (MF) and Sézary syndrome (SS)2,6,7
372 patients with MF and SS were evaluated across stage IB-IV for progression-free survival (PFS) as well as overall response rate (ORR) and duration of response (DoR) in multiple disease compartments (skin, blood, lymph nodes, viscera) for up to 5 years.
Mogamulizumab anti-CCR4 Antibody Versus ComparatOR In CTCL
POTELIGEO was studied in a broad range of patients6
- <15% CD4+CD26- or CD4+CD7- cells by flow cytometry
- ≥15% CD4+CD26- or CD4+CD7- cells by flow cytometry
- ≥1000/μL Sézary cells with positive clone, CD4:CD8 ratio ≥10, 40% CD4+CD7- cells, or ≥30% CD4+CD26-cells
|Stage||IB-IIA, 23%||IIB, 15%||III, 10%||IV, 52%|
|Age (years)||Median, 64||Min, 25||Max, 101|
|Sex||Males, 58%||Females, 42%|
|Race||White, 70%||African American, 13%||Asian, 7%||Other, 10%
Key exclusion criteria3
- Large cell transformation at study entry
- Active autoimmune diseases
- CNS metastasis
- Active infection requiring therapy
- Medical conditions requiring systemic corticosteroids or other immunosuppressive medication
CNS=central nervous system; CTCL=cutaneous T-cell lymphoma; PO=by mouth; R/R=relapsed or refractory
See the latest skin response data from the MAVORIC post hoc analysisWatch the POTELIGEO
Efficacy in Skin video
- Cowan R, Scarisbrick JJ, Zinzani PL, et al. Efficacy and safety of mogamulizumab by patient baseline blood tumour burden: a post hoc analysis of the MAVORIC trial. J Eur Acad Dermatol Venereol. 2021;doi:10.1111/jdv.17523.
- 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.
- Supplement to: 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.
- Olsen EA, Whittaker S, Kim YH, et al. Clinical end points and response criteria in mycosis fungoides and Sézary syndrome: a consensus statement of the International Society for Cutaneous Lymphomas, the United States Cutaneous Lymphoma Consortium, and the Cutaneous Lymphoma Task Force of the European Organisation for Research and Treatment of Cancer. J Clin Oncol. 2011;29(18):2598-2607.
- Jawed SI, Myskowski PL, Horwitz S, Moskowitz A, Querfeld C. Primary cutaneous T-cell lymphoma (mycosis fungoides and Sézary syndrome): part II. Prognosis, management, and future directions. J Am Acad Dermatol. 2014;70(2):223.e1-17; 240-242.
- POTELIGEO [package insert]. Kyowa Kirin Inc., Bedminster, NJ USA.
- Kim Y, 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(suppl):5300[abstract].
- Data on file. Kyowa Kirin Inc., Bedminster, NJ USA.