AstraZeneca reports Phase III EMERALD-3 results showing Imfinzi-based STRIDE regimen plus TACE ± lenvatinib significantly improves PFS in embolisation-eligible unresectable HCC.
Written By: Mahathi Palivela, PharmD
Reviewed By: Pharmacally Editorial Team
AstraZeneca has reported positive high-level results from the Phase III EMERALD-3 trial (NCT05301842), showing that an immunotherapy-based combination anchored by Imfinzi significantly improves progression-free survival (PFS) in patients with unresectable hepatocellular carcinoma (HCC) eligible for embolisation. The regimen Imjudo, durvalumab, lenvatinib, and transarterial chemoembolisation (TACE) demonstrated a statistically significant and clinically meaningful PFS benefit versus TACE alone.
At the first interim analysis, overall survival (OS), a key secondary endpoint, showed a favorable trend, although the data remain immature. Follow-up for OS and other secondary endpoints is ongoing.
STRIDE Regimen Moves Earlier in Treatment Paradigm
Patients in the experimental arms received the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab), administered before and alongside TACE, with or without lenvatinib. The STRIDE + TACE arm showed directional improvements in PFS and OS versus TACE alone, though not formally powered for comparison.
These findings support the potential role of introducing dual immunotherapy earlier in the treatment course for embolisation-eligible patients, a population with limited systemic options.
These findings come as Imfinzi continues to gain traction across GI cancers, including its recent approvals and regulatory endorsements in gastric and gastroesophageal cancer.
Clinical Context and Unmet Need in HCC
Hepatocellular carcinoma is the most common form of liver cancer and a leading cause of cancer-related death globally. In 2026, more than 200,000 patients are expected to be eligible for embolisation, yet most experience progression or recurrence within 6–10 months following TACE. In India, annual HCC cases exceed 20,000 (NCRP), highlighting a substantial unmet need for strategies that extend disease control beyond locoregional therapy.
Safety and Next Steps
The safety profile was consistent with the known profiles of the individual agents, with no new safety signals observed. AstraZeneca plans to present full results at an upcoming medical congress and is engaging with global regulatory authorities, including the FDA, European Medicines Agency, and Central Drugs Standard Control Organization, pending mature OS data.
Trial Design Overview
EMERALD-3 is a global, randomised, open-label Phase III trial conducted across 171 centres in 22 countries, enrolling 760 patients with unresectable, embolisation-eligible HCC. The study evaluates STRIDE plus TACE, with or without lenvatinib, versus TACE alone, with PFS as the primary endpoint and OS as a key secondary endpoint. The results build on findings from the HIMALAYA trial and extend the use of dual immunotherapy into earlier-stage disease.
References
Imfinzi plus Imjudo combined with lenvatinib and TACE demonstrated a statistically significant and clinically meaningful improvement in progression-free survival in embolisation-eligible unresectable liver cancer in EMERALD-3 Phase III trial, 02 April 2026, Imfinzi plus Imjudo combined with lenvatinib and TACE demonstrated a statistically significant and clinically meaningful improvement in progression-free survival in embolisation-eligible unresectable liver cancer in EMERALD-3 Phase III trial
Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination with TACE in Patients with Locoregional HCC (EMERALD-3), ClinicalTrials.gov ID NCT05301842, https://clinicaltrials.gov/study/NCT05301842
About the Writer
Mahathi Palivela is pursuing a PharmD and has a strong interest in clinical pharmacy and patient safety. She is passionate about handling and analyzing patient data, and translating clinical insights into clear, meaningful summaries. She aims to apply this interest in medical writing and pharmacovigilance, focusing on improving patient outcomes through careful data interpretation and communication