AstraZeneca reported positive Phase 3 EMERALD-3 results showing that Imfinzi (durvalumab) in combination with Imjudo (tremelimumab), lenvatinib and transarterial chemoembolization (TACE) significantly improved progression-free survival (PFS) versus TACE alone in patients with embolization-eligible unresectable hepatocellular carcinoma (HCC). Patients in the investigational arms received the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab), with or without lenvatinib, before TACE and then continued in combination with TACE. The data will be presented in an oral session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (abstract #LBA4000).
In a planned interim analysis, the STRIDE regimen plus lenvatinib and TACE reduced the risk of disease progression or death by 30% compared with TACE alone, corresponding to a PFS hazard ratio of 0.70 (95% CI 0.57–0.86; p=0.0007). Median PFS was 13.0 months with the combination versus 9.8 months with TACE alone, and the PFS benefit was broadly consistent across key prespecified subgroups. For the secondary endpoint of overall survival (OS), investigators observed a positive trend favoring the STRIDE plus lenvatinib and TACE arm versus TACE alone (HR 0.84; 95% CI 0.65–1.09; p=0.1814).
Although not formally tested at this analysis, the treatment arm evaluating STRIDE plus TACE also showed clinically meaningful improvements versus TACE alone. PFS in this arm had a hazard ratio of 0.71 (95% CI 0.56–0.91; nominal p=0.0062), and OS had a hazard ratio of 0.70 (95% CI 0.51–0.95; nominal p=0.0233). Median PFS was 12.9 months for STRIDE plus TACE compared with 8.1 months for TACE alone.
A pre-planned exploratory analysis comparing the two investigational arms found a PFS improvement favoring the lenvatinib-containing regimen in patients with non-viral etiology (HR 0.70; 95% CI 0.44–1.09). The EMERALD-3 trial will continue to follow patients for OS and other key secondary endpoints in both experimental arms.
“Patients with embolization-eligible liver cancer face the burden of repeated localized therapy and are in urgent need of new systemic treatment options to delay disease progression and recurrence,” said Ghassan Abou‑Alfa, MD, JD, MBA, PhD(hc), attending physician and professor of medicine at Memorial Sloan Kettering Cancer Center and principal investigator of the trial. He said EMERALD-3 represents a meaningful advance, noting that nearly one in three patients were alive and progression-free at two years when treated with the dual immunotherapy regimen with or without lenvatinib, alongside a trend toward improved survival.
Susan Galbraith, executive vice president, Oncology Haematology R&D at AstraZeneca, said the EMERALD-3 PFS results and early OS trend build on practice-changing data from the HIMALAYA Phase 3 trial and highlight the impact of using the STRIDE regimen in an earlier disease setting. She said the findings support the company’s strategy of moving novel immunotherapy combinations into earlier stages of cancer and underscore the opportunity to introduce new options for patients in this challenging liver cancer population.
The safety profiles of the combinations were consistent with those of the individual agents. Grade 3 or higher adverse events from all causes occurred in 71.4% of patients in the STRIDE plus lenvatinib and TACE arm and 64% in the STRIDE plus TACE arm, compared with 28.6% in the TACE-only arm.
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