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Pembrolizumab for Treatment-Refractory Metastatic Castration-Resistant Prostate Cancer: Multicohort, Open-Label Phase II KEYNOTE-199 Study

Journal of clinical oncology, 2020-02, Vol.38 (5), p.395-405 [Peer Reviewed Journal]

2019 by American Society of Clinical Oncology 2019 American Society of Clinical Oncology ;ISSN: 0732-183X ;ISSN: 1527-7755 ;EISSN: 1527-7755 ;DOI: 10.1200/jco.19.01638 ;PMID: 31774688

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  • Title:
    Pembrolizumab for Treatment-Refractory Metastatic Castration-Resistant Prostate Cancer: Multicohort, Open-Label Phase II KEYNOTE-199 Study
  • Author: Antonarakis, Emmanuel S ; Piulats, Josep M ; Gross-Goupil, Marine ; Goh, Jeffrey ; Ojamaa, Kristiina ; Hoimes, Christopher J ; Vaishampayan, Ulka ; Berger, Ranaan ; Sezer, Ahmet ; Alanko, Tuomo ; de Wit, Ronald ; Li, Chunde ; Omlin, Aurelius ; Procopio, Giuseppe ; Fukasawa, Satoshi ; Tabata, Ken-Ichi ; Park, Se Hoon ; Feyerabend, Susan ; Drake, Charles G ; Wu, Haiyan ; Qiu, Ping ; Kim, Jeri ; Poehlein, Christian ; de Bono, Johann Sebastian
  • Subjects: Medicin och hälsovetenskap ; ORIGINAL REPORTS
  • Is Part Of: Journal of clinical oncology, 2020-02, Vol.38 (5), p.395-405
  • Description: Pembrolizumab has previously shown antitumor activity against programmed death ligand 1 (PD-L1)-positive metastatic castration-resistant prostate cancer (mCRPC). Here, we assessed the antitumor activity and safety of pembrolizumab in three parallel cohorts of a larger mCRPC population. The phase II KEYNOTE-199 study included three cohorts of patients with mCRPC treated with docetaxel and one or more targeted endocrine therapies. Cohorts 1 and 2 enrolled patients with RECIST-measurable PD-L1-positive and PD-L1-negative disease, respectively. Cohort 3 enrolled patients with bone-predominant disease, regardless of PD-L1 expression. All patients received pembrolizumab 200 mg every 3 weeks for up to 35 cycles. The primary end point was objective response rate per RECIST v1.1 assessed by central review in cohorts 1 and 2. Secondary end points included disease control rate, duration of response, overall survival (OS), and safety. Two hundred fifty-eight patients were enrolled: 133 in cohort 1, 66 in cohort 2, and 59 in cohort 3. Objective response rate was 5% (95% CI, 2% to 11%) in cohort 1 and 3% (95% CI, < 1% to 11%) in cohort 2. Median duration of response was not reached (range, 1.9 to ≥ 21.8 months) and 10.6 months (range, 4.4 to 16.8 months), respectively. Disease control rate was 10% in cohort 1, 9% in cohort 2, and 22% in cohort 3. Median OS was 9.5 months in cohort 1, 7.9 months in cohort 2, and 14.1 months in cohort 3. Treatment-related adverse events occurred in 60% of patients, were of grade 3 to 5 severity in 15%, and led to discontinuation of treatment in 5%. Pembrolizumab monotherapy shows antitumor activity with an acceptable safety profile in a subset of patients with RECIST-measurable and bone-predominant mCRPC previously treated with docetaxel and targeted endocrine therapy. Observed responses seem to be durable, and OS estimates are encouraging.
  • Publisher: United States: American Society of Clinical Oncology
  • Language: English
  • Identifier: ISSN: 0732-183X
    ISSN: 1527-7755
    EISSN: 1527-7755
    DOI: 10.1200/jco.19.01638
    PMID: 31774688
  • Source: GFMER Free Medical Journals
    Alma/SFX Local Collection
    SWEPUB Freely available online
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