AstraZeneca has reported positive high-level data from the EMERALD-3 Phase III trial, evaluating Imfinzi (durvalumab) plus Imjudo (tremelimumab), lenvatinib and transarterial chemoembolisation (TACE) in unresectable hepatocellular carcinoma (HCC).
The regimen delivered a statistically significant and clinically meaningful improvement in progression-free survival compared with TACE alone.
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At the interim overall survival analysis, a key secondary endpoint, the combination also showed a trend towards improved overall survival compared with TACE alone.
Patients in the investigational groups received the STRIDE regimen, or Single Tremelimumab Regular Interval Durvalumab, with or without lenvatinib before TACE and then alongside TACE.
Although not formally tested at this stage, the treatment arm assessing the STRIDE regimen plus TACE against TACE alone demonstrated strong trends towards improved progression-free survival and overall survival.
The study will continue to assess overall survival and other key secondary endpoints in both investigational arms.
The open-label, randomised, multicentre, sponsor-blinded, global Phase III trial evaluated a single priming dose of Imjudo 300mg added to Imfinzi 1500mg, followed by Imfinzi every four weeks as the STRIDE regimen.
It assessed this combination plus TACE with or without lenvatinib versus TACE alone in 760 patients with unresectable HCC eligible for embolisation.
Participants were randomised in a 1:1:1 ratio to Arm A comprising TACE, Imfinzi, Imjudo and lenvatinib, Arm B comprising TACE, Imfinzi and Imjudo, and Arm C comprising TACE until each arm reached 175 participants.
Randomisation then continued in a 1:1 ratio to Arms A and C until each enrolled about 275 participants.
Patients received Imfinzi with Imjudo, plus TACE as needed, with or without lenvatinib concurrently, followed by Imfinzi with or without lenvatinib until disease progression. The trial ran at 171 centres across 22 countries in Asia, Europe, North America and South America.
AstraZeneca Oncology Haematology R&D executive vice-president Susan Galbraith 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.”
The safety profile of each combination was consistent with the established profiles of the individual medicines, and no new safety findings were identified.
Prior to this, AstraZeneca reported positive results from the efzimfotase alfa Phase III clinical trial programme for hypophosphatasia (HPP), a rare metabolic bone disorder.
