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

POTELIGEO

Skin response with POTELIGEO across blood classifications

Vorinostat

Skin response with vorinostat across blood classifications

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, 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
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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.

MAVORIC

Mogamulizumab anti-CCR4 Antibody Versus ComparatOR In CTCL

Flowchart describing the design of an open-label phase 3 trial in which POTELIGEO was evaluated

POTELIGEO was studied in a broad range of patients6

CTCL subtype: 56% MF and 44% SS

BLOOD CLASSIFICATION1

  • (n=64)
  • <15% CD4+CD26- or CD4+CD7- cells by flow cytometry
  • (n=31)
  • ≥15% CD4+CD26- or CD4+CD7- cells by flow cytometry
  • (n=91)
  • ≥1000/μL Sézary cells with positive clone, CD4:CD8 ratio ≥10, 40% CD4+CD7- cells, or ≥30% CD4+CD26-cells
Patient characteristics6,8
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% (Not reported)
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 POTELIGEO
Efficacy in Skin video
References:
  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. POTELIGEO [package insert]. Kyowa Kirin Inc., Bedminster, NJ USA.
  7. 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].
  8. Data on file. Kyowa Kirin Inc., Bedminster, NJ USA.

Indication

POTELIGEO® (mogamulizumab-kpkc) injection for intravenous infusion is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.

Important Safety Information

Warnings and Precautions

Dermatologic toxicity: Monitor patients for rash throughout the course of treatment. For patients who experienced dermatologic toxicity in Trial 1, the median time to onset was 15 weeks, with 25% of cases occurring after 31 weeks. Interrupt POTELIGEO for moderate or severe rash (Grades 2 or 3). Permanently discontinue POTELIGEO for life-threatening (Grade 4) rash or for any Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN).

Infusion reactions: Most infusion reactions occur during or shortly after the first infusion. Infusion reactions can also occur with subsequent infusions. Monitor patients closely for signs and symptoms of infusion reactions and interrupt the infusion for any grade reaction and treat promptly. Permanently discontinue POTELIGEO for any life-threatening (Grade 4) infusion reaction.

Infections: Monitor patients for signs and symptoms of infection and treat promptly.

Autoimmune complications: Interrupt or permanently discontinue POTELIGEO as appropriate for suspected immune-mediated adverse reactions. Consider the benefit/risk of POTELIGEO in patients with a history of autoimmune disease.

Complications of allogeneic HSCT after POTELIGEO: Increased risks of transplant complications have been reported in patients who received allogeneic HSCT after POTELIGEO. Follow patients closely for early evidence of transplant-related complications.

Adverse Reactions

The most common adverse reactions (reported in ≥10% of patients) with POTELIGEO in the clinical trial were rash, including drug eruption (35%), infusion reaction (33%), fatigue (31%), diarrhea (28%), drug eruption (24%), upper respiratory tract infection (22%), musculoskeletal pain (22%), skin infection (19%), pyrexia (17%), edema (16%), nausea (16%), headache (14%), thrombocytopenia (14%), constipation (13%), anemia (12%), mucositis (12%), cough (11%), and hypertension (10%).

You are encouraged to report suspected adverse reactions to Kyowa Kirin, Inc. at 1-844-768-3544 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see additional Important Safety Information in full Prescribing Information as well as Patient Information.

Important Safety Information

Indication

POTELIGEO® (mogamulizumab-kpkc) injection for intravenous infusion is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.

Warnings and Precautions

Dermatologic toxicity: Monitor patients for rash throughout the course of treatment. For patients who experienced dermatologic toxicity in Trial 1, the median time to onset was 15 weeks, with 25% of cases occurring after 31 weeks. Interrupt POTELIGEO for moderate or severe rash (Grades 2 or 3). Permanently discontinue POTELIGEO for life-threatening (Grade 4) rash or for any Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN).

Infusion reactions: Most infusion reactions occur during or shortly after the first infusion. Infusion reactions can also occur with subsequent infusions. Monitor patients closely for signs and symptoms of infusion reactions and interrupt the infusion for any grade reaction and treat promptly. Permanently discontinue POTELIGEO for any life-threatening (Grade 4) infusion reaction.

Infections: Monitor patients for signs and symptoms of infection and treat promptly.

Autoimmune complications: Interrupt or permanently discontinue POTELIGEO as appropriate for suspected immune-mediated adverse reactions. Consider the benefit/risk of POTELIGEO in patients with a history of autoimmune disease.

Complications of allogeneic HSCT after POTELIGEO: Increased risks of transplant complications have been reported in patients who received allogeneic HSCT after POTELIGEO. Follow patients closely for early evidence of transplant-related complications.

Adverse Reactions

The most common adverse reactions (reported in ≥10% of patients) with POTELIGEO in the clinical trial were rash, including drug eruption (35%), infusion reaction (33%), fatigue (31%), diarrhea (28%), drug eruption (24%), upper respiratory tract infection (22%), musculoskeletal pain (22%), skin infection (19%), pyrexia (17%), edema (16%), nausea (16%), headache (14%), thrombocytopenia (14%), constipation (13%), anemia (12%), mucositis (12%), cough (11%), and hypertension (10%).

You are encouraged to report suspected adverse reactions to Kyowa Kirin, Inc. at 1-844-768-3544 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see additional Important Safety Information in full Prescribing Information as well as Patient Information.