波鲁斯托巴特 (HBM4003) 加托利帕利马布作为晚期肝细胞癌患者的二线治疗:多中心,开放标签,I期研究

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Ningning Zhang¹, Tian Liu¹, Ming Luo¹

¹Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.

Clinical cancer research : an official journal of the American Association for Cancer Research

|May 16, 2025

概括

波鲁斯托巴特和托利帕利马布的组合在先进的肝细胞癌 (HCC) 患者中显示出前所未有的PD-1/PD-L1抑制剂治疗的前景. 这种新疗法在这个特定的患者群体中显示出40%的客观反应率.

科学领域:

肝细胞癌研究肝细胞癌研究
免疫治疗是一种免疫疗法.
在瘤学瘤学.

背景情况:

晚期肝细胞癌 (HCC) 是一个重大的治疗挑战.
新型免疫治疗策略对于改善患者的治疗结果至关重要.
了解免疫检查点在HCC中的作用是开发有效治疗的关键.

研究的目的:

评估porustobart (HBM4003),一种抗CTLA-4抗体的疗效和安全性,与toripalimab结合使用.
评估这种组合作为高级HCC患者的二线治疗.
为了探索抗PD-1/PD-L1-先天和预先治疗的队列中的患者反应.

主要方法:

一个I期临床试验,涉及两个高级HCC患者队列.
第1队列:前不服用抗PD-1/PD-L1药物的患者,接受了第一线抗VEGFR氨酸激酶抑制剂.
队列2:患者先前有抗PD-1/PD-L1和抗VEGF/VEGFR治疗失败. 剂量:波鲁斯托巴特 (0.45毫克/千克) +托里帕利马布 (240毫克) 每隔21天. 主要终点:目标响应率 (ORR).

主要成果:

在队列1中有16名患者,在队列2中有12名患者. 整体ORR为23.1% (26名可评估患者).
第1组 (原先没有服用抗PD-1/PD-L1) 的ORR为40.0%. 第2组没有显示出客观的反应.
无进展生存时间的中位数为4.2个月 (第1组为5.7个月,第2组为3.8个月). 生物标志物表明治疗后响应者和T细胞激活的Tregs增加. 安全性概况显示,治疗出现的不良事件发生率很高 (96.4%).

结论:

波鲁斯托巴特和托利帕利马布的组合在以前没有抗PD-1/PD-L1先进的HCC患者中显示出令人鼓舞的疗效.
这种方案为二线治疗提供了潜在的可管理的安全概况.
需要在更大的试验中进行进一步的调查来证实这些发现.

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