en.Wedoany.com Reported - Results from AstraZeneca's Phase III Emerald-3 trial showed that the regimen of durvalumab combined with tremelimumab, lenvatinib, and transarterial chemoembolization (QETA) achieved a statistically significant and clinically relevant improvement in progression-free survival (PFS) compared to QETA alone in patients with unresectable hepatocellular carcinoma eligible for embolization.

Patients in the experimental arm received the Stride regimen (single dose of tremelimumab plus regular durvalumab) with or without lenvatinib prior to QETA, followed by combination therapy with QETA. These results were presented in an oral report at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

In the planned interim analysis, the Stride regimen combined with lenvatinib and QETA reduced the risk of disease progression or death by 30% compared to QETA alone (PFS hazard ratio [HR] 0.70; 95% confidence interval [CI]: 0.57-0.86; p=0.0007). The median PFS was 13.0 months for patients receiving this regimen versus 9.8 months for the QETA-alone group. The PFS improvement was generally consistent across key prespecified patient subgroups.

For the secondary endpoint of overall survival (OS), a positive trend was observed for the Stride regimen combined with lenvatinib and QETA compared to QETA alone (HR 0.84; 95% CI: 0.65-1.09; p=0.1814).

Although not formally assessed in this analysis, the key secondary endpoints of PFS and OS in the treatment arm evaluating Stride regimen plus QETA versus QETA alone showed clinically significant improvements in PFS (HR 0.71; 95% CI: 0.56-0.91; nominal p=0.0062) and OS (HR 0.70; 95% CI: 0.51-0.95; nominal p=0.0233) compared to QETA alone. The median PFS was 12.9 months for the Stride regimen plus QETA versus 8.1 months for QETA alone.

In a prespecified exploratory analysis comparing the two experimental arms, an improvement in PFS was observed in patients with non-viral etiology in the arm including lenvatinib (HR 0.70; 95% CI: 0.44-1.09). The trial will continue to evaluate OS and other key secondary endpoints in both arms.

Ghassan Abou-Alfa, principal investigator of the trial and Professor of Medicine at Memorial Sloan Kettering Cancer Center, stated that liver cancer patients eligible for embolization face repeated local treatments and urgently need new systemic treatment options to delay disease progression and recurrence. He believes the Emerald-3 trial may represent a significant advance for patients, with nearly one-third of those receiving the dual immunotherapy regimen (with or without lenvatinib) remaining alive and progression-free at two years.

Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, said that based on the practice-changing Phase III HIMALAYA trial results, these PFS results and early OS trends from the Emerald-3 trial could have a major impact, moving the Stride regimen to an earlier stage. These results advance the strategy of shifting novel immunotherapy regimens to earlier stages of cancer and underscore the opportunity to provide new treatment options for patients in this liver cancer setting.

Ana Peiró, Medical Director of Oncology at AstraZeneca Spain, noted that the Emerald-3 study results in unresectable hepatocellular carcinoma presented at ASCO this year reinforce the company's commitment to clinical research in oncology pathologies and stages with high unmet medical needs. These data support the development of new therapeutic alternatives for professionals managing advanced and particularly complex tumors such as liver cancer. Results like those from Emerald-3 highlight the importance of continuing to advance strategies integrating clinical innovation aimed at improving the management and outcomes of these patients.

The safety profile of each combination was consistent with the known safety profiles of the individual drugs. Grade 3 or higher adverse events of any cause occurred in 71.4% of patients in the Stride plus lenvatinib and QETA arm, 64% in the Stride plus QETA arm, and 28.6% in the QETA-alone arm.

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