Four-year overall survival update from the multinational phase 3 HIMALAYA trial of first-line tremelimumab plus durvalumab for uHCC

The multinational phase 3 HIMALAYA trial randomized patients with previously untreated unresectable hepatocellular carcinoma (uHCC) to STRIDE (single dose priming tremelimumab followed by regular interval durvalumab), durvalumab monotherapy, or sorafenib. A four-year overall survival update of the trial has now been published. The figure shows that the OS HR for STRIDE versus sorafenib was 0.78 (95% CI 0.67-0.92) with 36-months OS rates 30.7% versus 19.8%, and 48-month OS rates 25.2% versus 15.1%. The long-term OS benefit with STRIDE was observed across clinically relevant subgroups and was further improved in patients who achieve disease control. There were no unexpected toxicities. Durvalumab monotherapy maintained OS noninferiority to sorafenib. The authors conclude that the update showed unprecendented three- and four-year OS rates with first-line STRIDE for uHCC.