福克斯:一个第三阶段,随机的,开放的标签研究,对先进肝细胞癌患者的Pexa-Vec (JX-594) 和Sorafenib连续治疗
Ghassan K Abou-Alfa1,2, Peter R Galle3, Yee Chao4
1Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Liver cancer
|May 17, 2024
概括
用pexa-vec和sorafenib进行顺序治疗并没有改善晚期肝细胞癌 (HCC) 患者的结局. 与单独使用索拉芬尼相比,组合治疗没有显示任何额外的临床益处.
科学领域:
- 在瘤学瘤学.
- 病毒学 病毒学
- 免疫治疗是一种免疫疗法.
背景情况:
- 内注射pexastimogene devacirepvec (pexa-vec),一种性疫苗病毒,在肝细胞癌 (HCC) 中显示了局部和远程瘤反应.
- 假设用pexa-vec接着索拉费尼布的连续治疗可以提高晚期HCC的疗效.
研究的目的:
- 为了评估序列性pexastimogene devacirepvec (pexa-vec) 加索拉费尼布的疗效和安全性,与单独的索拉费尼布相比,在患有晚期HCC的患者中.
主要方法:
- 一个随机的,第三阶段的,开放的标签研究,比较顺序的pexa-vec加索拉费尼布和索拉费尼布单一治疗.
- 主要终点:整体存活率 (OS). 二级终点:进展时间 (TTP),无进展生存率,整体反应率 (ORR) 和疾病控制率 (DCR).
- 在16个国家招募了459名患有晚期HCC的患者.
主要成果:
- 由于缺乏证明的益处,该研究在临时分析中提前终止.
- 佩克萨维克加索拉费尼布的中位寿命为12.7个月,仅索拉费尼布的14.0个月.
- 组合手臂中TTP的中位数较短 (2.0个月与4.2个月),ORR与pexa-vec加sorafenib相似,DCR较低.
结论:
- 序列性pexa-vec加sorafenib没有改善晚期HCC的临床益处,并且与单独sorafenib相比,与更糟糕的结局有关.
- 在组合手臂中观察到更高的严重不良事件率,包括肝衰竭.
- 未来的瘤性病毒疗法开发应该考虑检查点抑制剂的作用.
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