The addition of durvalumab and bevacizumab to transarterial chemoembolization (TACE) significantly improved progression-free survival in patients with unresectable hepatocellular carcinoma who were eligible for embolization. According to the study authors, this is the first trial to demonstrate improved clinical outcomes for immunotherapy-based combinations with TACE in these patients. The research was presented by Lencioni et al at the 2024 ASCO Gastrointestinal Cancers Symposium (Abstract LBA432).
About EMERALD-1
“Research in other studies suggested that TACE would work well with two other types of anticancer therapy: immunotherapy, which attacks tumors using the immune system, and anti-VEGF therapy, which inhibits vascular endothelial growth factor (VEGF)—a protein which, when expressed in tumors, can promote blood flow to the tumor,” said lead study author Riccardo Lencioni, MD, of the Pisa University School of Medicine in Pisa, Italy.
EMERALD-1 is a double-blind, global, three-arm phase III study in which 616 patients with embolization-eligible unresectable hepatocellular carcinoma were randomly assigned to receive treatment with durvalumab (a PD-L1 inhibitor) plus bevacizumab (an anti-VEGF therapy) and TACE, durvalumab plus TACE, or TACE alone.
Key Findings
Patients treated with the combination of durvalumab, bevacizumab, and TACE demonstrated a significant improvement in progression-free survival vs participants treated with TACE alone (median progression-free survival = 15.0 vs 8.2 months). There was not a statistically significant difference in progression-free survival in patients treated with durvalumab and TACE vs TACE alone. Objective response rate and time to progression were also superior in the durvalumab, bevacizumab, and TACE group.
Grade 3 or 4 treatment-related side effects were experienced by 32.5% of patients in the durvalumab, bevacizumab, and TACE group; 15.1% of those in the durvalumab and TACE group; and 13.5% of those in the TACE-alone group. Discontinuation of treatment occurred in 8.4% of those the durvalumab, bevacizumab, and TACE group; 4.3% of those in the durvalumab and TACE group; and 3.5% of those in the TACE group.
Next Steps
The researchers continue to follow patients on the EMERALD-1 trial for the secondary endpoint of overall survival and are also studying different immune checkpoint inhibitors and embolization-based approaches for patients with embolization-eligible hepatocellular carcinoma.
ASCO Expert Perspective
“These results of the EMERALD-1 trial have the potential to establish a new standard of care for the treatment of unresectable hepatocellular carcinoma, a complex disease with poor prognosis, by showing for the first time that adding an immunotherapy-based combination to TACE significantly improved progression-free survival,” said Cathy Eng, MD, FACP, FASCO, ASCO Expert in Gastrointestinal Cancers.
Disclosure: The EMERALD-1 study was funded by AstraZeneca. For full disclosures of the study authors, visit coi.asco.org.
