Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong, China.
Department of Surgery, Queen Mary Hospital, The University of Hong Kong, Hong Kong, China.
Expert Rev Gastroenterol Hepatol. 2021 Jun;15(6):589-598. doi: 10.1080/17474124.2021.1899808. Epub 2021 Mar 19.
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.
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.
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.
近年来,晚期不可切除肝细胞癌(HCC)的系统治疗已经发生了变化。2020 年 3 月,纳武利尤单抗联合伊匹单抗被 FDA 批准用于治疗先前接受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缓解率和令人鼓舞的总生存期,且安全性可管理。
本文综述了先前接受索拉非尼治疗的晚期 HCC 中纳武利尤单抗-伊匹单抗的药理学、疗效和安全性。还将描述和比较其他现有的晚期 HCC 全身治疗选择,并与纳武利尤单抗-伊匹单抗进行比较。将讨论不同剂量方案的影响、正在进行的研究和纳武利尤单抗-伊匹单抗的未来发展。我们专注于来自上述 CheckMate-040 队列 4 注册试验的分析。
FDA 批准纳武利尤单抗-伊匹单抗用于晚期 HCC 的二线治疗是治疗晚期 HCC 的重要进展。然而,需要进一步研究来优化剂量方案,并探索纳武利尤单抗-伊匹单抗在其他组合和环境中的应用。