LONDON (dpa-AFX) - British drug major AstraZeneca PLC (AZN, AZN.L) announced Thursday positive high-level results from its EMERALD-3 Phase III trial of Imfinzi (durvalumab) in combination with Imjudo (tremelimumab), lenvatinib and transarterial chemoembolisation (TACE) in embolisation-eligible unresectable liver cancer.
The company said the trial demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival versus TACE alone in patients with unresectable hepatocellular carcinoma or HCC eligible for embolisation.
At the interim analysis for overall survival, a key secondary endpoint, the Imfinzi plus Imjudo combined with lenvatinib and TACE combination also demonstrated a trend toward overall survival improvement versus TACE alone.
According to the firm, in 2026, more than 200,000 patients with HCC, the most common type of liver cancer, will be eligible for embolisation, a standard-of-care procedure that blocks the blood supply to the tumour and can also deliver chemotherapy directly to the liver. However, most patients who receive embolisation experience disease progression or recurrence within six to ten months.
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins. It counters the tumour's immune-evading tactics and releasing the inhibition of immune responses.
EMERALD-3 is a randomised, open-label, sponsor-blinded, multicentre, global Phase III trial in a total of 760 patients with unresectable HCC eligible for embolisation. The trial was conducted in 171 centres across 22 countries, including in North America, Europe, South America and Asia.
In the trial, a single priming dose of Imjudo 300mg was added to Imfinzi 1500mg followed by Imfinzi every four weeks plus TACE with or without lenvatinib versus TACE alone.
The company noted that patients in the investigational arms were treated with the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab), with or without lenvatinib, before TACE, and then alongside TACE.
The safety profile for each combination was consistent with the known profiles of each medicine, and there were no new safety findings, the firm added.
The trial will continue to follow overall survival and other key secondary endpoints in both investigational arms.
AstraZeneca plans to present the trial data at a forthcoming medical meeting and to share with global regulatory authorities.
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said, 'EMERALD-3 now shows that bringing the dual immunotherapy STRIDE regimen earlier, alongside TACE and lenvatinib, can further improve outcomes in earlier-stage liver cancer. This builds on the HIMALAYA Phase III trial data in patients with advanced, unresectable disease, where the STRIDE regimen has already demonstrated durable overall survival benefit. We are discussing these positive data with global regulatory authorities while awaiting the final results from the key secondary endpoints.'
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