Durvalumab and tremelimumab, with or without lenvatinib, combined with transarterial chemoembolisation in participants with embolisation-eligible hepatocellular carcinoma (EMERALD-3): a global, randomised, open-label, sponsor-blinded, phase 3 study

Adding immunotherapy (durvalumab plus tremelimumab) and lenvatinib to transarterial chemoembolisation prolonged progression-free survival but NOT overall survival. In the phase 3 EMERALD-3 trial (n=760, embolisation-eligible hepatocellular carcinoma), median progression-free survival was 13.0 versus 9.8 months with chemoembolisation alone (HR 0.70; 95% CI 0.57-0.86; p=0.0007), while median overall survival of 39.5 versus 34.7 months did not reach significance (HR 0.84; 95% CI 0.65-1.09; p=0.18). The cost was substantial: serious adverse events occurred in 64% of patients in the triplet arm versus 23% with chemoembolisation alone, and treatment-related deaths in 2% versus 1%. Overall survival follow-up is ongoing.