Mogamulizumab-kpkc

(Poteligeo®)

Mogamulizumab-kpkc

Drug updated on 9/4/2024

Dosage FormInjection (intravenous: 20 mg/5 mL [4 mg/mL])
Drug ClassCC chemokine receptor type 4 (CCR4)- directed monoclonal antibodies
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy.

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Summary
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  • Poteligeo (mogamulizumab-kpkc) is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy.
  • This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
  • Adult T-cell Leukemia-Lymphoma (ATL) Survival Outcomes: Mogamulizumab treatment demonstrated a median overall survival (OS) ranging from 2.2 to 17.6 months, with a 30% OS time ranging from 8.7 to 27.1 months. For comparison, allogeneic hematopoietic stem cell transplantation (allo-HSCT) showed a median OS of 3.8 to 6.2 months and a 30% OS time of 7.5 to 19.8 months, while other chemotherapy treatments exhibited a median OS of 4.1 to 20.3 months and a 30% OS time of 7.1 to 17.0 months.
  • Mycosis Fungoides (MF) Response Rates: The complete response (CR) rate to treatment in MF ranged from 0% to 83%, with a median CR of 31%. The objective response rate (ORR) varied between 0% and 88%, with a median ORR of 47%. Comparative studies of PUVA and its combinations with other treatments, such as intralesional IFN-α or bexarotene, indicated little to no difference in CR and ORR when combined with PUVA compared to PUVA alone.
  • Mogamulizumab-associated cutaneous adverse events included rash (affecting up to 25% of patients), spongiotic/psoriasiform dermatitis (22%), papules and/or plaques (16.1%), cutaneous granulomatosis (11.4%), morbilliform or erythrodermic dermatitis (9.4%), and photodermatitis (7.1%); rash was the most frequent adverse event leading to drug discontinuation.
  • Safety outcomes for mogamulizumab in Adult T-cell Leukemia-Lymphoma (ATL) were not detailed beyond general survival outcomes.
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Poteligeo (mogamulizumab-kpkc) Prescribing Information.2023Kyowa Kirin, Inc., Bedminster, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines