Blood involvement was associated with a greater reduction in skin involvement for POTELIGEO1,a-c
- 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)1
- By cycle 6, patients treated with POTELIGEO experienced at least a 30% response in skin across all blood classifications1
- 16/91 (17.6%) patients with B2 blood classification treated with mogamulizumab had a 100% improvement compared to 3/93 (3.2%) patients with B2 blood classification treated with vorinostat1
POTELIGEO
Vorinostat
BLOOD CLASSIFICATION
-
-
<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
or 1 of the following:- 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 and Sézary Syndrome5
- Routine evaluation for Mycosis Fungoides and Sézary Syndrome 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 and Sézary Syndrome2,6,7
372 patients with Mycosis Fungoides (MF) and Sézary Syndrome (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).
MAVORIC
Mogamulizumab anti-CCR4 Antibody Versus ComparatOR In CTCL
The MAVORIC trial included a broad range of patients2,6,8
BLOOD CLASSIFICATION1,3
-
-
<15%
CD4+CD26- or CD4+CD7- flow cytometry
-
-
≥15%
CD4+CD26- or CD4+CD7- cells by flow cytometry
-
-
≥1000/μL Sézary cells with
positive clone
or 1 of the following:- CD4:CD8 ratio ≥10,
- 40% CD4+CD7- cells, or
- ≥30% CD4+CD26- cells
| Patient characteristics6,8 | ||||
|---|---|---|---|---|
| Age (years) | ||||
| Age (years) | Median, 64 | Min, 25 | Max, 101 | |
| Sex | ||||
| Sex | Males, 58% | Females, 42% | ||
| Race | ||||
| Race | White, 70% | African American, 13% |
Asian, 7% | Other, 10% (Not reported) |
| Prior systemic therapies | ||||
| Prior systemic therapies | Median, 3 | Min, 0 | Max, 18 | |
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 analysis
Watch the POTELIGEOEfficacy 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;35(11):2225-2238.
- 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.
- 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. Supplementary appendix published online August 9, 2018. doi.org/10.1016/S1470-2045(18)30379-6
- 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., Princeton, 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., Princeton, NJ USA.