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Introduction <p>This study aimed to evaluate the safety and preliminary efficacy of serplulimab, a novel programmed death-1 inhibitor, with or without bevacizumab biosimilar HLX04 as first-line treatment in patients with advanced hepatocellular carcinoma.</p> Methods <p>This open-label, multicenter phase 2 study (clinicaltrials.gov identifier NCT03973112) was conducted in China and consisted of four treatment groups: group A (serplulimab 3&#xa0;mg/kg plus HLX04 5&#xa0;mg/kg, subsequent-line), group B (serplulimab 3&#xa0;mg/kg plus HLX04 10&#xa0;mg/kg, subsequent-line), group C (serplulimab 3&#xa0;mg/kg, subsequent-line) and group D (serplulimab 3&#xa0;mg/kg plus HLX04 10&#xa0;mg/kg, first-line). Group D was the only group in which participants received the study treatment in the first-line setting. The primary endpoint was safety.</p> Results <p>Following previous report on groups A and B, results of group D are herein presented. As of February 7, 2023, 61 patients were enrolled and were followed up for a median of 25.5&#xa0;months. Grade ≥ 3 treatment-emergent adverse events were reported by 29 (47.5%) patients. One patient died from adverse events that were considered related to study treatment. Among the patients with at least one post-baseline tumor assessment (n = 58), the objective response rate was 29.3% (95% CI: 18.1–42.7) as assessed by an independent radiological review committee (IRRC) per RECIST v1.1. IRRC-assessed median progression-free survival was 7.3&#xa0;months (95% CI: 2.8–11.0), and median overall survival was 20.4&#xa0;months (95% CI: 15.0–NE), respectively.</p> Conclusion <p>Serplulimab combination therapy with HLX04 showed a manageable safety profile as well as preliminary efficacy in patients with advanced HCC in the first-line setting.</p>

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Phase 2 study of serplulimab with the bevacizumab biosimilar HLX04 in the first-line treatment of advanced hepatocellular carcinoma

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年1月3日

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  • Zhenggang Ren,
  • Guoliang Shao,
  • Jie Shen,
  • Li Zhang,
  • Xu Zhu,
  • Weijia Fang,
  • Guoping Sun,
  • Yuxian Bai,
  • Jianbing Wu,
  • Lianxin Liu,
  • Yuan Yuan,
  • Jingdong Zhang,
  • Zhen Li,
  • Ling Zhang,
  • Tao Yin,
  • Jincai Wu,
  • Xiaoli Hou,
  • Haoyu Yu,
  • Jing Li,
  • Qingyu Wang,
  • Jun Zhu,
  • Jia Fan,
  • Zhenggang Ren,
  • Guoliang Shao,
  • Jie Shen,
  • Li Zhang,
  • Xu Zhu,
  • Weijia Fang,
  • Guoping Sun,
  • Yuxian Bai,
  • Jianbing Wu,
  • Lianxin Liu,
  • Yuan Yuan,
  • Jingdong Zhang,
  • Zhen Li,
  • Ling Zhang,
  • Tao Yin,
  • Jincai Wu,
  • Zhendong Chen,
  • Peiguo Cao,
  • Zhong Xie,
  • Hongyu Zhang,
  • Feixiang Wu,
  • Xianhai Mao,
  • Xianglin Yuan,
  • Gaojun Teng,
  • Jinglan Jin,
  • Haixin Huang,
  • Chunyue Wang,
  • Guohua Yu

摘要

Introduction

This study aimed to evaluate the safety and preliminary efficacy of serplulimab, a novel programmed death-1 inhibitor, with or without bevacizumab biosimilar HLX04 as first-line treatment in patients with advanced hepatocellular carcinoma.

Methods

This open-label, multicenter phase 2 study (clinicaltrials.gov identifier NCT03973112) was conducted in China and consisted of four treatment groups: group A (serplulimab 3 mg/kg plus HLX04 5 mg/kg, subsequent-line), group B (serplulimab 3 mg/kg plus HLX04 10 mg/kg, subsequent-line), group C (serplulimab 3 mg/kg, subsequent-line) and group D (serplulimab 3 mg/kg plus HLX04 10 mg/kg, first-line). Group D was the only group in which participants received the study treatment in the first-line setting. The primary endpoint was safety.

Results

Following previous report on groups A and B, results of group D are herein presented. As of February 7, 2023, 61 patients were enrolled and were followed up for a median of 25.5 months. Grade ≥ 3 treatment-emergent adverse events were reported by 29 (47.5%) patients. One patient died from adverse events that were considered related to study treatment. Among the patients with at least one post-baseline tumor assessment (n = 58), the objective response rate was 29.3% (95% CI: 18.1–42.7) as assessed by an independent radiological review committee (IRRC) per RECIST v1.1. IRRC-assessed median progression-free survival was 7.3 months (95% CI: 2.8–11.0), and median overall survival was 20.4 months (95% CI: 15.0–NE), respectively.

Conclusion

Serplulimab combination therapy with HLX04 showed a manageable safety profile as well as preliminary efficacy in patients with advanced HCC in the first-line setting.