Finotonlimab (PD-1 inhibitor) plus bevacizumab (bevacizumab biosimilar) as first-tier therapy for late-stage hepatocellular carcinoma: a randomized phase 2/3 trial
Chuanhua Zhao, Yanqiao Zhang, Gang Wang, Jinfang Zheng, Weiqing Chen, Zheng Lu, Zhuang Li, 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, Jianmin Chen, Chuan Jin, Lei Zhang, Jun Lv, Cheng-Wu Zhang, Xiaoman Zhang, Y. Wang, Su Huo, Qiang Zhou, Wenlin Gai, Liangzhi Xie, Jianming Xu
Abstract
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.