Multinational phase 3 trial of adding durvalumab with or without bevacizumab to transarterial chemoembolization for hepatocellular carcinoma

Transarterial chemoembolization (TACE) is standard of care for patients with unresectable hepatocellular carcinoma (HCC). The median progression-free survival is approximately 7 months. The multinational phase 3 EMERALD-1 study randomized patients 1:1:1 to TACE plus durvalumab plus bevacizumab (n=204), TACE plus durvalumab plus placebo (n=207), or TACE plus placebo (n=205). The median progression-free survival in these groups was 15.0 months versus 10.0 months versus 8.2 months, respectively. The PFS HR was 0.77 (p=0.032) for TACE plus durvalumab plus bevacizumab versus TACE plus placebo, and 0.94 (p=0.64) for TACE plus durvalumab versus TACE plus placebo. There were no grade 5 treatment-related adverse events in the group with TACE plus durvalumab plus bevacizumab. Patients continue to be followed-up for overall survival. The authors conclude that addition of durvalumab plus bevacizumab to TACE for unresectable HCC was associated with significantly improved PFS.