ABSTRACT

Introduction

The systemic treatment of advanced, unresectable hepatocellular carcinoma (HCC) has undergone an evolution in recent years. In March 2020, a combination of nivolumab and ipilimumab was approved by the FDA for treatment of patients with advanced HCC who received prior sorafenib. This was based on the results of the phase I/II CheckMate-040 cohort 4 trials, which showed a promising overall response rate and encouraging overall survival with a manageable safety profile.

Areas covered

This article reviews the pharmacology, efficacy and safety of nivolumab-ipilimumab in advanced HCC with prior sorafenib. Other existing systemic treatment options for advanced HCC will be described and compared to nivolumab-ipilimumab. Impact of different dose regimes, ongoing research and future developments of nivolumab-ipilimumab will be discussed. We focus on the analysis from the aforementioned CheckMate-040 cohort 4 registration trial.

Expert opinion

The approval of nivolumab-ipilimumab in the second-line treatment of advanced HCC by the FDA is an important development for treatment of advanced HCC. However, further investigations are needed to optimize dosing regimens and explore the use of nivolumab-ipilimumab in other combinations and settings.

中文翻译：

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Nivolumab + Ipilimumab 用于既往接受过索拉非尼治疗的肝细胞癌患者

摘要

介绍

近年来，不可切除的晚期肝细胞癌 (HCC) 的全身治疗经历了演变。2020 年 3 月，纳武单抗和易普利姆玛的组合被 FDA 批准用于治疗先前接受过索拉非尼治疗的晚期 HCC 患者。这是基于 I/II 期 CheckMate-040 队列 4 试验的结果，该试验显示出有希望的总体反应率并鼓励总体生存率，并具有可控的安全性。

覆盖区域

本文综述了纳武单抗-易普利姆玛在既往索拉非尼治疗晚期 HCC 中的药理学、疗效和安全性。将描述其他现有的晚期 HCC 全身治疗选择，并与纳武单抗-易普利姆玛进行比较。将讨论不同剂量方案的影响、正在进行的研究和 nivolumab-ipilimumab 的未来发展。我们专注于上述 CheckMate-040 队列 4 注册试验的分析。

专家意见

FDA 批准纳武单抗-易普利姆玛二线治疗晚期 HCC 是晚期 HCC 治疗的重要进展。然而，需要进一步研究以优化给药方案并探索纳武单抗-易普利姆玛在其他组合和设置中的使用。