Multinational phase 3 trial of first-line tislelizumab versus sorafenib for unresectable hepatocellular carcinoma

Additional first-line treatments are needed for unresectable hepatocellular carcinoma (uHCC). Tislelizumab (anti-PD-1) demonstrated efficacy and tolerability as second-line uHCC treatment. The multinational phase 3 RATIONALE-301 trial compared first-line tislelizumab versus sorafenib for uHCC. In this trial of 674 uHCC patients, tislelizumab demonstrated overall survival noninferiority compared with sorafenib, with numerically higher and more durable objective responses, and a more favorable safety profile. The authors conclude that tislelizumab may represent a potential first-line treatment option for uHCC (visual abstract).