EMERALD-1: TACE plus immunotherapy meets primary endpoint in unresectable HCC

Presented by

Dr Riccardo Lencioni, University of Pisa, Italy

Conference

ASCO GI 2024

Trial

Phase 3, EMERALD-1

Doi
https://doi.org/10.55788/faca026c

Transarterial chemoembolisation (TACE) plus durvalumab and bevacizumab achieved a significantly improved progression-free survival (PFS) compared with TACE and placebo in patients with unresectable hepatocellular carcinoma (HCC) who were eligible for embolisation. This combination therapy has the potential to set a new standard-of-care for this population.

The phase 3 EMERALD-1 trial (NCT03778957) randomised 616 patients with unresectable HCC who were eligible for embolisation 1:1:1 to TACE plus placebo, TACE plus durvalumab, or TACE plus durvalumab and bevacizumab. The primary outcome was the PFS comparison between the placebo arm and the bevacizumab arm. Dr Riccardo Lencioni (University of Pisa, Italy) presented the findings [1].

The median PFS was significantly longer in the bevacizumab arm than in the placebo arm (15.0 vs 8.2 months; HR 0.77; 95% CI 0.61–0.98; log-rank P=0.032). The corresponding 18-month PFS rates were 43.1% and 28.3%. No significant difference regarding median PFS was observed between the durvalumab and placebo arms (10.0 vs 8.2 months; HR 0.94; 95% CI 0.75–1.19; log-rank P=0.64). According to Dr Lencioni, the safety profile of the experimental therapy was manageable and consistent with the known safety profiles of TACE, durvalumab, and bevacizumab in unresectable HCC.

“This is the first global, phase 3 trial to demonstrate a clinically meaningful improvement in PFS with an immunotherapy- and TACE-based regimen in patients with unresectable HCC who were eligible for embolisation,” decided Dr Lencioni.

Lencioni R, et al. EMERALD-1: A phase 3, randomized, placebo-controlled study of transarterial chemoembolization combined with durvalumab with or without bevacizumab in participants with unresectable hepatocellular carcinoma eligible for embolization. LBA 432, ASCO Gastrointestinal Cancers Symposium 2024, 18–20 January, San Francisco, CA, USA.

Related Articles