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.
Zhao et al. (Wed,) studied this question.