Five-year follow-up of nivolumab monotherapy for advanced hepatocellular carcinoma in sorafenib-naïve and sorafenib-experienced patients

Patients with advanced hepatocellular carcinoma (aHCC) have a poor prognosis. The multinational phase 1-2 trial evaluated nivolumab in multiple cohorts of aHCC-patients. Five-year follow-up of the nivolumab monotherapy cohorts with sorafenib-naïve and sorafenib-experienced patients has now been published. The median overall survival was 26.6 months (95% CI 16.6-30.6) in the sorafenib-naïve cohort and 15.5 months (13.0-18.2) in the sorafenib-experience cohort, with 3-year OS-rates 28% and 20% and 5-year OS rates 14% and 12%, respectively. No new safety signals were identified. Biomarker analyses showed that in both cohorts baseline PD-L1 expression ≥ 1% was associated with higher ORR and longer OS compared with baseline PD-L1 expression < 1%. The authors conclude that with 5 years of follow-up, nivolumab monotherapy continued to provide durable clinical benefit with manageable safety in sorafenib-naïve and sorafenib-experienced patients with aHCC.