Drug updated on 9/4/2024
Dosage Form | Injection (intravenous: 20 mg/5 mL [4 mg/mL]) |
Drug Class | CC 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
- 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 Title | Year | Source |
---|---|---|
Poteligeo (mogamulizumab-kpkc) Prescribing Information. | 2023 | Kyowa Kirin, Inc., Bedminster, NJ |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Clinicopathological definition, management and prognostic value of mogamulizumab-associated rash and other cutaneous events: a systematic review. | 2024 | Journal of the European Academy of Dermatology and Venereology |
Systematic review of survival outcomes for relapsed or refractory adult T-cell leukemia-lymphoma. | 2022 | European Journal of Haematology |
Interventions for mycosis fungoides. | 2020 | The Cochrane Database of Systematic Reviews |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Mogamulizumab for previously treated mycosis fungoides and sézary syndrome: an evidence review group perspective of a NICE single technology appraisal. | 2022 | PharmacoEconomics |
Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of lymphoma. | 2020 | Journal for ImmunoTherapy of Cancer |