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<p>We aimed to assess the tolerability and efficacy of finotonlimab (an anti-programmed cell death protein-1 antibody) in combination with SCT510, a bevacizumab biosimilar, versus sorafenib in unresectable advanced HCC. This randomized phase 2 and 3 study (ClinicalTrials.gov, NCT04560894; Chinadrugtrials.org.cn, CTR20201976 and CTR20201974) was performed at 67 hospitals in China. HCC patients (<i>n</i> = 398) were included between 11 November 2020 and 28 September 2022. In phase 2, patients received intravenous finotonlimab (200 mg every 3 weeks) combined with SCT510 (15 mg/kg every 3 weeks). In phase 3, 346 patients were randomized (2:1) to either the finotonlimab plus SCT510 (dual-agent) group or the sorafenib group. The median follow-up time for the dual-agent therapy and sorafenib groups was 19.9 and 19.0 months, respectively. Median PFS, assessed by BICR according to RECIST 1.1, was significantly longer in the dual-agent group (7.1 months [95% confidence intervals {CI}: 6.1, 8.4]) than in the sorafenib group (2.9 months [95% CI: 2.8, 4.1]; stratified hazard ratio [HR]: 0.5, 95% CI: 0.38, 0.65, <i>p</i> &lt; 0.0001). Median OS was also significantly longer in patients receiving finotonlimab plus SCT510 (22.1 months [18.6, not available]) than in those receiving sorafenib (14.2 months [95% CI: 10.2, 15.8]; HR: 0.60 [95% CI: 0.44, 0.81], <i>p</i> &lt; 0.0008). Finotonlimab in combination with bevacizumab demonstrated favorable efficacy, in comparison to sorafenib, as a first-line treatment for unresectable HCC, with a manageable safety profile.</p>

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Finotonlimab (PD-1 inhibitor) plus bevacizumab (bevacizumab biosimilar) as first-tier therapy for late-stage hepatocellular carcinoma: a randomized phase 2/3 trial

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  • 发表日期：

    2025年8月6日

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  • Chuanhua Zhao,
  • Yanqiao Zhang,
  • Gang Wang,
  • Jinfang Zheng,
  • Weiqing Chen,
  • Zheng Lu,
  • Li Zhuang,
  • Shanzhi Gu,
  • Lei Han,
  • Zhendong Zheng,
  • Zujiang Yu,
  • Yongsheng Yang,
  • Hongmei Sun,
  • Xiaoyong Wei,
  • Ying Cheng,
  • Hailan Lin,
  • Bo Zhu,
  • Guicheng Wu,
  • Kaijian Lei,
  • Wei Wang,
  • Yuwen Wang,
  • Kehe Chen,
  • Ximing Xu,
  • Cuiping Zheng,
  • Yanzhi Bi,
  • Sijuan Ding,
  • Jingdong Zhang,
  • Wei Li,
  • Hailong Liu,
  • Jun Wang,
  • Xianling Liu,
  • Yangfeng Du,
  • Lianming Cai,
  • Jingran Wang,
  • Zhanxiong Luo,
  • Baocai Xing,
  • Jie Shen,
  • Lin Yang,
  • Jianbing Wu,
  • Ou Jiang,
  • Zhigang Peng,
  • Xiuli Liu,
  • Bangwei Cao,
  • Liangfang Shen,
  • Aibing Xu,
  • Aimin Li,
  • Shaojun Chen,
  • Ting Fu,
  • Jian Chen,
  • Chuan Jin,
  • Lei Zhang,
  • Jun Lv,
  • Chengwu Zhang,
  • Xiaoman Zhang,
  • Yu Wang,
  • Huo Su,
  • Qiang Zhou,
  • Wenlin Gai,
  • Liangzhi Xie,
  • Jianming Xu

摘要

We aimed to assess the tolerability and efficacy of finotonlimab (an anti-programmed cell death protein-1 antibody) in combination with SCT510, a bevacizumab biosimilar, versus sorafenib in unresectable advanced HCC. This randomized phase 2 and 3 study (ClinicalTrials.gov, NCT04560894; Chinadrugtrials.org.cn, CTR20201976 and CTR20201974) was performed at 67 hospitals in China. HCC patients (n = 398) were included between 11 November 2020 and 28 September 2022. In phase 2, patients received intravenous finotonlimab (200 mg every 3 weeks) combined with SCT510 (15 mg/kg every 3 weeks). In phase 3, 346 patients were randomized (2:1) to either the finotonlimab plus SCT510 (dual-agent) group or the sorafenib group. The median follow-up time for the dual-agent therapy and sorafenib groups was 19.9 and 19.0 months, respectively. Median PFS, assessed by BICR according to RECIST 1.1, was significantly longer in the dual-agent group (7.1 months [95% confidence intervals {CI}: 6.1, 8.4]) than in the sorafenib group (2.9 months [95% CI: 2.8, 4.1]; stratified hazard ratio [HR]: 0.5, 95% CI: 0.38, 0.65, p < 0.0001). Median OS was also significantly longer in patients receiving finotonlimab plus SCT510 (22.1 months [18.6, not available]) than in those receiving sorafenib (14.2 months [95% CI: 10.2, 15.8]; HR: 0.60 [95% CI: 0.44, 0.81], p < 0.0008). Finotonlimab in combination with bevacizumab demonstrated favorable efficacy, in comparison to sorafenib, as a first-line treatment for unresectable HCC, with a manageable safety profile.