Comparison of immune checkpoint inhibitor monotherapy versus Sorafenib in unresectable hepatocellular carcinoma.

e16160 Background: Combination immune checkpoint inhibitors (ICI) or with a vascular endothelial growth factor receptor (VEGFR) agent is now the standard 1st line (1L) therapy in patients with advanced/unresectable hepatocellular carcinoma (uHCC). Currently, there is a paucity of data on the use of ICI monotherapy when combination ICI/VEGFR is contraindicated. Therefore, we conducted a meta-analysis to evaluate the efficacy and safety outcomes of ICI monotherapy versus sorafenib in patients with uHCC in the 1L setting. Methods: A systematic search of electronic databases was conducted for randomized controlled trials comparing ICI versus sorafenib in the treatment of uHCC. Efficacy endpoints were overall survival (OS), objective response rates (ORR), and progression free survival (PFS). Safety endpoints of interests were any adverse events (AE) and > grade 3 AEs. We performed random effects meta-analysis to estimate odds ratio (OR) with 95% confidence intervals for individual endpoints. Results: A total of 2 studies with 1521 patients were included in the final analysis. Compared to sorafenib, ICIs were associated with improved OS [OR 0.75; 95% confidence interval (CI) 0.6-0.94]. Similarly, ICI had increased odds of ORR [OR 2.99; 95% CI 1.93-4.62] and PFS [OR 1.41; 95% CI 1.07-1.85] compared to the sorafenib arm. In the safety analyses, ICIs were associated with reduced risk of > grade 3 AE [OR 0.40; 95% CI 0.22-0.72] and any AEs [OR 0.25; 95% CI 0.12-0.55] when compared to sorafenib. Conclusions: Our meta-analysis suggests that ICI monotherapy has improved OS, PFS, ORR, and better safety profile in 1L uHCC compared to sorafenib.