This is the report of a randomized phase 3 trial assessing the efficacy and safety of first-line nivolumab versus sorafenib in patients with unresectable HCC. 743 patients were randomized 1:1 to receive nivolumab (N=371; 240 mg intravenously every 2 weeks) or sorafenib (N=372; 400 mg orally twice daily). Median OS was 16.4 months (95%CI 13.9-18.4) with nivolumab and 14.7 months (11.9-17.2) with sorafenib (HR 0.5; 95%CI 0.72-1.02; p=0.075); the protocol-defined significance level of p=0.0419 was not reached. The most common grade 3 or worse treatment-related adverse events were palmar-plantar erythrodysaesthesia (<1% of patients in the nivolumab group vs 14% of patients in the sorafenib group), AST increase (6% vs 4%), and hypertension (0 vs 7%). Serious treatment-related adverse events were reported in 12% of patients receiving nivolumab and 11% of patients receiving sorafenib.

(Yau, T., et al. – Lancet Oncol, January 2022)

Read more