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.

Study at-a-Glance

ALEXANDRIA, Va. —The addition of durvalumab and bevacizumab to TACE significantly improved progression-free survival in patients with unresectable hepatocellular carcinoma (uHCC) that were eligible for embolization. According to the authors, this is the first trial to demonstrate improved clinical outcomes for immunotherapy-based combinations with TACE in these patients. The research will be presented at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, taking place January 18-20 in San Francisco, California and online.

About the Study

“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, from 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 HCC were randomized to treatment with durvalumab – an immunotherapy – 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, meaning they are likely to live longer without their cancer growing, spreading or getting worse 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 3/4 treatment-related side effects were experienced by 32.5% of the durvalumab, bevacizumab, and TACE group; 15.1% of the durvalumab and TACE group; and 13.5% of the TACE group. Discontinuation of treatment occurred in 8.4% of the durvalumab, bevacizumab, and TACE group; 4.3% of the durvalumab and TACE group; and 3.5% of 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 HCC.

The EMERALD-1 study was funded by AstraZeneca.

View the full embargoed abstract (Please note: You must be logged in to ASCO's Media Headquarters to access this link.)

View author disclosures

View the News Planning Team disclosures: https://old-prod.asco.org/sites/new-www.asco.org/files/content-files/about-asco/pdf/2024-asco-gi-npt-disclosures.pdf

ATTRIBUTION TO THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY GASTROINTESTINAL CANCERS SYMPOSIUM IS REQUESTED IN ALL COVERAGE.

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