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 ...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.展开更多
基金National Science and Technology Major Projects of China[2019ZX09732-001]provided funding.
文摘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.
