Phase 1/2 Study of the Safety and Tolerability of Nivolumab Plus Crizotinib for the First-Line Treatment of Anaplastic Lymphoma Kinase Translocation - Positive Advanced Non-Small Cell Lung Cancer (CheckMate 370)
Phase 1/2 Study of the Safety and Tolerability of Nivolumab Plus Crizotinib for the First-Line Treatment of Anaplastic Lymphoma Kinase Translocation - Positive Advanced Non-Small Cell Lung Cancer (CheckMate 370)
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DOI：
10.1016/j.jtho.2018.02.022
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发表时间：
2018-05-01
影响因子：
20.4
通讯作者：
Blumenschein, George, Jr.
中科院分区：
文献类型：
--
作者：
Spigel, David R.;Reynolds, Craig;Blumenschein, George, Jr.
克唑替尼是一种间变性淋巴瘤激酶（ALK）抑制剂，是ALK易位阳性晚期非小细胞肺癌（NSCLC）的一线治疗药物；然而，患者最终会进展。免疫疗法，包括程序性死亡-1抑制剂nivolumab，已经在NSCLC患者中产生了持久的反应和长期的总生存期。我们假设，结合靶向治疗和免疫治疗可能会导致更多的患者产生反应和/或更持久的反应。在此，我们报告了一项研究的数据，该研究评估了尼武单抗和克唑替尼在先前未经治疗的晚期ALK易位阳性NSCLC患者中的应用。方法：CheckMate 370中的E组是一个单组队列，旨在评估一线纳武单抗（240 mg / 2周）加克唑替尼（250 mg / 2天）治疗ALK易位阳性NSCLC患者的安全性。如果肝毒性= 3，则达到主要安全终点。5例患者（38%）部分缓解。结论：这些发现不支持进一步评价纳武单抗240 mg / 2周加克唑替尼250 mg / 2天。(C) 2018年国际肺癌研究协会。Elsevier Inc.出版。版权所有。
Introduction: Crizotinib, an anaplastic lymphoma kinase (ALK) inhibitor, is a first-line treatment for ALK translocation-positive advanced non-small cell lung cancer (NSCLC); however, patients eventually progress. Immunotherapies, including the programmed death-1 inhibitor nivolumab, have resulted in durable responses and long-term overall survival in patients with NSCLC. We hypothesized that combining targeted therapy with immunotherapy could result in more patients with responses and/or more durable responses. Herein we report data from a study assessing nivolumab plus crizotinib in patients with previously untreated advanced ALK translocation-positive NSCLC.Methods: Group E in CheckMate 370 was a single-arm cohort designed to evaluate the safety of first-line nivolumab (240 mg every 2 weeks) plus crizotinib (250 mg twice daily) in patients with ALK translocation-positive NSCLC. The primary endpoint of safety would be met if = 3 hepatic toxicities. Five patients (38%) had a partial response.Conclusions: These findings do not support further evaluation of nivolumab 240 mg every 2 weeks plus crizotinib 250 mg twice daily. (C) 2018 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.