Background: Cancer immunotherapy targeting immune checkpoint inhibitors (ICIs) has been shown to be a promising strategy in the treatment of various malignancies. Despite the proven efficacy and tolerability of ICIs based on 113 clinical trials globally, data regarding the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of ICIs in the Chinese population are lacking. As of June 1, 2018, not a single ICI has been approved by the China Food and Drug Administration.
Materials and methods: Currently, there are 26 ongoing phase I studies actively investigating the safety, antitumor activity, and PK/PD profiles of six multinational corporation (MNC)-developed ICIs and eight domestic-developed ICIs in the Chinese population. Data regarding study designs, treatment interventions, targeted populations, and the current states of these studies were collected and summarized.
Results: We outlined 8 phase I studies assessing MNC-developed ICIs and 18 phase I studies assessing domestic-developed ICIs in the Chinese population in this article, in order to provide researchers with a clear picture of the status quo of ICI research and developments in China.
Conclusion: Immuno-oncology in China remains at a preliminary stage. Despite the substantial amount of phase I studies of ICIs, early-phase studies with designs incorporating characteristics of Chinese patients are still lacking.
Implications for practice: Cancer immunotherapy targeting immune checkpoint inhibitors (ICIs) has led to a paradigm shift in the treatment of various malignancies. However, data regarding the pharmacokinetic and pharmacodynamic profiles of ICIs in the Chinese population are lacking. Currently, there are 26 phase I studies actively investigating 14 ICIs in China. In this article, we outlined all the ongoing phase I studies of multinational corporation-developed ICIs and domestic-developed ICIs targeting the Chinese population, hoping to shed some light on the status quo of ICI research and developments in China.
摘要
背景。靶向免疫检查点抑制剂 (ICI) 的肿瘤免疫治疗已被证明是一项治疗各种恶性肿瘤颇具前景的方案。尽管基于全球 113 项临床试验，ICI 的疗效和耐受性已经得到了证实，但是，有关中国人群所用 ICI 的药代动力学 (PK) 和药效学 (PD) 概况的数据仍然不足。截至 2018 年 6 月 1 日，没有一个ICI被中国食品药品监督管理总局批准使用。
材料和方法。目前，有 26 项正在进行的 I 期研究正在积极研究六大跨国公司 (MNC) 开发的中国人群所用 ICI 和八大国内开发的中国人群所用 ICI 的安全性、抗肿瘤活性以及 PK/PD 概况。我们对有关研究设计、治疗干预、目标人群以及此类研究现状的数据进展了收集和汇总。
结果。在本文中，我们概述了 8 项评估 MNC 开发的中国人群所用 ICI 的 I 期研究和 18 项评估国内开发的中国人群所用 ICI 的 I 期研究，旨在为研究人员提供中国 ICI 研发现状的清晰图谱。
结论。中国的免疫肿瘤学仍处于起步阶段。尽管对 ICI 进行了大量的 I 期研究，但纳入中国患者特征的早期研究仍然不足。
实践意义:靶向免疫检查点抑制剂 (ICI) 的肿瘤免疫治疗致使各种恶性肿瘤的治疗发生了范式转变。然而，有关中国人群所用 ICI 的药代动力学和药效学概况的数据仍然不足。目前，有 26 项 I 期研究在积极研究中国的 14 种 ICI。在本文中，我们概述了针对中国人群的跨国公司开发的 ICI 和国内开发的 ICI 所有正在进行的 I 期研究，旨在阐明中国 ICI 研发的现状。
Keywords: China; Immune checkpoint inhibitors; Pharmacodynamics; Pharmacokinetics; Phase I studies.
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