Transarterial chemoembolization (TACE) has been the global standard of care for patients with unresectable embolization-eligible hepatocellular carcinoma (eeHCC) for over two decades, with a median progression-free survival (PFS) of 8-10 months.¹ STRIDE (Single Tremelimumab Regular Interval Durvalumab) is an established first-line treatment for unresectable advanced hepatocellular carcinoma (HCC), with sustained overall survival (OS) benefit through 6 years of follow-up.¹ Evidence suggests that combining TACE with immunotherapy and anti-angiogenic therapy may further enhance antitumor activity.¹

EMERALD-3 was a global, randomized, open-label, sponsor-blinded, multicenter phase 3 trial evaluating STRIDE ± lenvatinib + TACE in patients with unresectable eeHCC.¹ Eligible patients were ≥18 years of age, Child-Pugh class A liver function, had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1, no extrahepatic disease, no prior systemic therapy, and disease amenable to embolization but unsuitable for curative treatment.¹

A total of 760 patients were initially randomized 1:1:1 to receive STRIDE (tremelimumab 300mg + durvalumab 1,500mg on day 1, followed by durvalumab 1,500mg every 4 weeks) + lenvatinib (8mg or 12mg once daily) + TACE (arm A), STRIDE + TACE (arm B), or TACE alone (arm C).1 Durvalumab and lenvatinib continued for up to 36 months or until disease progression, unacceptable toxicity, or withdrawal of consent.1 Patients were stratified by geographical region, prior palliative embolization, and baseline tumor burden.¹

The primary endpoint was PFS assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 for arm A vs. arm C.¹ Key secondary endpoints included OS for arm A vs. arm C, together with PFS and OS comparisons between arm B and arm C.1 Baseline characteristics were broadly balanced across treatment groups.¹

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“EMERALD-3 is the first phase 3 study to demonstrate that a STRIDE-based regimen improves clinical outcomes when combined with TACE, supporting its role as a potential new treatment option for patients with unresectable eeHCC”

Professor Ghassan K. Abou-Alfa
Memorial Sloan Kettering Cancer Center,
New York, United States