Key clinical point: In addition to being safe, perioperative administration of nivolumab with or without ipilimumab may elicit a major response with longer recurrence-free survival in patients with resectable hepatocellular carcinoma (HCC).
Main finding: Grade 3/4 treatment-related adverse events were observed in 43% and 23% of patients with nivolumab+ipilimumab and nivolumab alone, respectively ( P = .69). Of the patients who underwent surgery, nivolumab alone and nivolumab+ipilimumab caused a major pathology-related response in 33% (95% CI 7.5%-70.1%) and 27% (95% CI 6%-61%), respectively, who showed improved recurrence-free survival vs. those with no pathological response (log-rank P = .049).
Study details : This was a single-center, phase 2 trial including 27 adult patients with resectable HCC who were randomly assigned to receive nivolumab alone (n = 13) or nivolumab plus ipilimumab (n = 14) before and after partial hepatectomy.
Disclosures: The study was sponsored by Bristol Myers Squibb (BMS) and the US National Institutes of Health. A few authors, including the lead author, served as a consultants/advisors or were stock owners of and received research funding/honoraria from numerous organizations including BMS.
Source: Kaseb AO et al. Lancet Gastroenterol Hepatol. 2022;7(3):P208-18 (Jan 19). Doi: 10.1016/S2468-1253(21)00427-1.