國家衛生研究院 NHRI:Item 3990099045/12648
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    题名: A phase Ib study of ADI-PEG 20 plus pembrolizumab in advanced solid cancers
    作者: Chang, KY;Chiang, NJ;Yen, CJ;Wu, SY;Chen, SH;Johnston, A;Bomalaski, JS;Wu, BW;Chen, LT
    贡献者: National Institute of Cancer Research
    摘要: Background: Arginine deprivation with pegylated arginine deiminase (ADI-PEG 20) has been shown to upregulate tumor programmed death-ligand 1 (PD-L1) expression and T cell infiltration. Current phase Ib study is to explore the feasibility of combining ADI-PEG 20 with pembrolizumab in patients with advanced solid tumors. Methods: Eligibility criteria included treatment-failure patients with measurable lesions. Pre-treatment tumor biopsy was required. In the “3 + 3” designed dose-escalation part, patients were enrolled to receive ADI-PEG 20 36 mg/m2 at day 1, 8 and 15, and pembrolizumab (1 mg/kg or 200 mg) at day 1, every 3 weeks to determine the maximum tolerated dose (MTD) of pembrolizumab for expansion cohort study. In the expansion cohort part, patients with platinum-failed HNSCC would receive both ADI-PEG 20 and pembrolizumab (at MTD) from day 1; while patients in translation cohort who were required to have < 50% PD-L1 expressing tumors would receive 3 doses of weekly ADI-PEG 20 and a post-ADI-PEG 20 biopsy before the start of combination treatment. The primary endpoint was safety and tolerability. Secondary endpoints included progression-free survival, overall survival, response rate, and the changes of tumorous PD-L1 expression and T-cell infiltration after treatment with ADI-PEG 20 with and without pembrolizumab. Results: The recruitment of dose-escalation cohorts was completed between July 2017-January 2018. There was only one dose-limiting toxicity, grade 3 hepatitis, observed in a patient in 1 mg/kg dose level; while none in the 200 mg dose level. Among them, two (22.2%) had partial response (PR) and four (44.4%) had stable disease. The two PRs were in thymus cancer and nasopharyngeal carcinoma, with both having 100% tumor baseline PD-L1 expression. The most common grade 3/4 adverse event (AE) was neutropenia, which occurred in seven patients. For serious AEs, two had neutropenic fever lasting less than one week in the third week, and one had tumor bleeding because of tumor progression in the eighth week. The expansion cohorts are enrolling. Conclusions: Co-administration of ADI-PEG 20 and pembrolizumab is feasible. The major toxicity is neutropenia which is transient and manageable. Responses were observed with the regimen. Clinical trial information: NCT03254732.
    日期: 2018-05
    關聯: Journal of Clinical Oncology. 2018 May;36(15, Suppl. S):Meeting Abstract 2556.
    Link to: http://dx.doi.org/10.1200/JCO.2018.36.15_suppl.2556
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0732-183X&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000442916001335
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