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A phase 3 study shows a clinicaly meaningful benefit for camrelizumab plus rivoracemib compared to sorafenib in first-line therapy of patients with unresectable hepatocellular carcinoma
The anti-PD-1 antibody camrelizumab plus the VEGFR2-targeted tyrosine-kinase inhibitor rivoracemib significantly improved progression-free survival and overall survival compared to sorafenib in first-line therapy of unresectable hepatocellular carcinoma, as shown by a new study published in The Lancet.
The study is a phase 3 randomized, open-label international trial designed to compare the efficacy and safety of a combination of an immune checkpoint inhibitor and an anti-angiogenic tyrosine-kinase inhibitor versus sorafenib in a first-line setting. 543 patients with unresectable or metastatic hepatocellular carcinoma who had not previously received any systemic treatment were randomly assigned to receive either camrelizumab 200 mg intravenously every 2 weeks plus rivoceranib 250 mg orally once daily or sorafenib 400 mg orally twice daily; median progression-free survival was significantly improved with camrelizumab–rivoceranib versus sorafenib (5.6 versus 3.7 months) and median overall survival was significantly extended too (22.1 versus 15.2 months). As authors say, «To our knowledge, the median overall survival of 22.1 months in the camrelizumab– rivoceranib group was the longest one observed for any systemic treatment in global phase 3 trials in unresectable hepatocellular carcinoma. This is the first phase 3 study to report significant benefits in both progression-free survival and overall survival with the combination of an anti-PD-1/PD-L1 antibody and an orally administered, small-molecule tyrosin-kinase inhibitor over standard tyrosin-kinase inhibitor for unresectable hepatocellular carcinoma in the first-line setting. Survival benefits with camrelizumab plus rivoceranib were generally consistent across clinically relevant subgroups; in addition, safety was manageable with no new safety signals identified. The overall favorable benefit- to-risk profile supports camrelizumab with rivoceranib as a new first-line treatment option for patients with unresectable hepatocellular carcinoma who have not previously received any systemic therapy», authors conclude.