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Pembrolizumab in Relapsed and Refractory Mycosis Fungoides and Sézary Syndrome: A Multicenter Phase II Study

  1. Author:
    Khodadoust, Michael S
    Rook, Alain H
    Porcu, Pierluigi
    Foss, Francine
    Moskowitz, Alison J
    Shustov, Andrei
    Shanbhag, Satish
    Sokol, Lubomir
    Fling, Steven P
    Ramchurren, Nirasha
    Pierce, Robert
    Davis, Asa
    Shine, Richard
    Li, Shufeng
    Fong, Sophia
    Kim, Jinah
    Yang, Yi
    Blumenschein, Wendy M
    Yearley, Jennifer H
    Das,Biswajit
    Patidar,Rajesh
    Datta, Vivekananda
    Cantu,Erin
    McCutcheon,Justine
    Karlovich,Chris
    Williams,Mickey
    Subrahmanyam, Priyanka B
    Maecker, Holden T
    Horwitz, Steven M
    Sharon, Elad
    Kohrt, Holbrook E
    Cheever, Martin A
    Kim, Youn H

  2. Author Address

    Stanford University, Stanford, CA., University of Pennsylvania, Philadelphia, PA., Thomas Jefferson University, Philadelphia, PA., Yale University, New Haven, CT., Memorial Sloan Kettering Cancer Center, New York, NY., Seattle Cancer Care Alliance, Seattle, WA., Johns Hopkins University, Baltimore, MD., Moffitt Cancer Center, Tampa, FL., Fred Hutchinson Cancer Research Center, Seattle, WA., Merck Research Laboratories, Kenilworth, NJ., Frederick National Laboratory for Cancer Research, Frederick, MD., National Cancer Institute, Bethesda, MD †Deceased.,
    1. Year: 2020
    2. Date: JAN 1
    3. Epub Date: 2019 09 18
  2. Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology
    1. 38
    2. 1
    3. Pages: 20-+
  4. Type of Article: Article
  5. Article Number: JCO1901056
  6. ISSN: 0732-183X
  1. Abstract:

    PURPOSE: To assess the efficacy of pembrolizumab in patients with advanced relapsed or refractory mycosis fungoides (MF) or Sezary syndrome (SS).PATIENTS AND METHODS: CITN-10 is a single-arm, multicenter phase II trial of 24 patients with advanced MF or SS. Patients were treated with pembrolizumab 2 mg/kg every 3 weeks for up to 24 months. The primary end point was overall response rate by consensus global response criteria.RESULTSPatients had advanced-stage disease (23 of 24 with stage IIB to IV MF/SS) and were heavily pretreated with a median of four prior systemic therapies. The overall response rate was 38% with two complete responses and seven partial responses. Of the nine responding patients, six had 90% or more improvement in skin disease by modified Severity Weighted Assessment Tool, and eight had ongoing responses at last follow-up. The median duration of response was not reached, with a median response follow-up time of 58 weeks. Immune-related adverse events led to treatment discontinuation in four patients. A transient worsening of erythroderma and pruritus occurred in 53% of patients with SS. This cutaneous flare reaction did not result in treatment discontinuation for any patient. The flare reaction correlated with high PD-1 expression on Sezary cells but did not associate with subsequent clinical responses or lack of response. Treatment responses did not correlate with expression of PD-L1, total mutation burden, or an interferon-gamma gene expression signature.CONCLUSION: Pembrolizumab demonstrated significant antitumor activity with durable responses and a favorable safety profile in patients with advanced MF/SS.

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External Sources

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  2. DOI: 10.1200/JCO.19.01056
  3. PMID: 31532724
  4. View record in Web of Science®
  5. WOS: 000538777900003

Library Notes

  1. Fiscal Year: FY2019-2020
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