EMERALD-1 — TL;DR
Design: Phase III, randomized, double-blind — durvalumab ± bevacizumab + TACE vs placebo/TACE; N=616; eeHCC. (Lancet 2025)
PFS (primary, met): 15.0 vs 8.2 mo; HR 0.77 (95% CI 0.61–0.98; P=0.032) for durvalumab + bevacizumab + TACE. (Lancet 2025, DCO1)
OS (final, NOT met): D+bev+TACE 29.9 vs 33.3 mo, HR 1.10 (95% CI 0.87–1.39; P=0.470); durva+TACE 33.6 vs 33.3 mo, HR 0.93 (95% CI 0.74–1.19; P=0.666). (ESMO GI 2026, Sangro 183O)
Regulatory: Investigational — no FDA approval for durvalumab + TACE in eeHCC as of July 2026.
Sponsor / drugs: AstraZeneca — durvalumab (Imfinzi) ± bevacizumab + TACE.
Physicians Leading the EMERALD-1 Conversation
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Trial Overview
EMERALD-1 (NCT03778957)
Unresectable, embolization-eligible hepatocellular carcinoma (eeHCC). 616 patients (204 durvalumab+bevacizumab+TACE; 207 durvalumab+TACE; 205 TACE/placebo). Sponsor: AstraZeneca. Regimen: durvalumab (Imfinzi) ± bevacizumab + TACE. TACE has been the standard of care for embolization-eligible HCC for over two decades; EMERALD-1 tested whether adding PD-L1 inhibition (durvalumab) with or without anti-VEGF (bevacizumab) to TACE could improve outcomes.
OS final analysis presented by Bruno Sangro, MD (Clínica Universidad de Navarra) — ESMO GI 2026, abstract 183O at ESMO GI 2026 (#ESMOGI26), Munich, Jul 1–4 2026 (OS final analysis); primary PFS at ASCO GI 2024 / Lancet 2025.
Efficacy Results
Progression-Free Survival — primary endpoint MET (Lancet 2025, DCO1)
Median PFS 15.0 mo (95% CI 11.1–18.9) with durvalumab + bevacizumab + TACE vs 8.2 mo (95% CI 6.9–11.1) with placebo/TACE; HR 0.77 (95% CI 0.61–0.98; two-sided log-rank P=0.032).
PFS benefit confirmed: HR 0.77 Source: The Lancet (2025) — EMERALD-1 primary analysisOverall Survival — final analysis, NOT significant (ESMO GI 2026, Sangro 183O)
Durvalumab + bevacizumab + TACE: Median OS 29.9 mo with durvalumab + bevacizumab + TACE vs 33.3 mo with TACE alone; HR 1.10 (95% CI 0.87–1.39; P=0.470) — NOT significant.
Durvalumab + TACE: Median OS 33.6 mo with durvalumab + TACE vs 33.3 mo with TACE alone; HR 0.93 (95% CI 0.74–1.19; P=0.666) — NOT significant.
No OS benefit for either arm Source: ESMO GI 2026 — Sangro, abstract 183ORegulatory Status
EMERALD-1 vs EMERALD-3: What KOLs Are Debating
EMERALD-1 confirmed that adding durvalumab (± bevacizumab) to TACE improves PFS — but at final analysis this did not convert into an overall-survival benefit. The companion trial EMERALD-3 (STRIDE ± lenvatinib + TACE) met its primary PFS endpoint and showed an encouraging early OS trend, producing a genuinely contrasting picture within the same disease.
An emerging discussion point among HCC KOLs — framed explicitly as hypothesis, not established fact — concerns the timing of immunotherapy relative to embolization. As Dr. Mark Yarchoan (Johns Hopkins) noted at #ESMOGI26, in EMERALD-3 immunotherapy was given before TACE (essentially neoadjuvant IO), whereas in EMERALD-1 IO came after TACE; he described this as "pure conjecture" but a potentially key difference. Others, including the ESMO GI discussant, emphasized that PFS alone may not be a sufficient surrogate for OS in this setting, and that early mortality, patient selection, liver decompensation, and limited post-TACE systemic therapy all complicate interpretation.
About This Page
This profile aggregates verified physician commentary on EMERALD-1 from X (#ESMOGI26) with primary-source clinical data. Every numeric claim is labelled with its source and data cut. KOL sentiment is derived from verbatim tweet text.
Compiled and reviewed by the KOL Pulse research team, led by Brian Shields, Founder, KOL Pulse. All clinical figures are traceable to the labelled primary source and data cut. Last updated 2026-07-05.
EMERALD FAQ
What is the EMERALD-1 trial?
EMERALD-1 (NCT03778957) is an AstraZeneca Phase III, randomized, double-blind, placebo-controlled trial of durvalumab (Imfinzi) with or without bevacizumab added to transarterial chemoembolization (TACE) versus TACE alone in 616 patients with unresectable, embolization-eligible hepatocellular carcinoma (eeHCC).
Did EMERALD-1 improve overall survival?
No. At the final overall survival analysis presented at ESMO GI 2026, neither durvalumab-containing arm improved OS. Durvalumab + bevacizumab + TACE had a median OS of 29.9 vs 33.3 months with TACE alone (HR 1.10; 95% CI 0.87–1.39; P=0.470), and durvalumab + TACE had a median OS of 33.6 vs 33.3 months (HR 0.93; 95% CI 0.74–1.19; P=0.666). Neither was statistically significant.
What was the EMERALD-1 progression-free survival result?
The primary endpoint was met: median PFS was 15.0 months with durvalumab + bevacizumab + TACE versus 8.2 months with placebo/TACE (HR 0.77; 95% CI 0.61–0.98; P=0.032), as published in The Lancet (2025). The PFS benefit was confirmed but did not translate into an OS benefit at final analysis.
Is durvalumab + TACE FDA-approved for HCC?
No. As of July 2026 there is no FDA approval for durvalumab + TACE (± bevacizumab) in embolization-eligible HCC; the regimen remains investigational in this setting. AstraZeneca has said it will update its regulatory-discussion plans as appropriate.
How does EMERALD-1 differ from EMERALD-3?
EMERALD-1 tested durvalumab ± bevacizumab given largely after TACE and missed OS. EMERALD-3 tested the STRIDE regimen (durvalumab + a single priming dose of tremelimumab) ± lenvatinib, dosed before TACE, and met its primary PFS endpoint with an encouraging early OS trend. An emerging KOL discussion point is that IO timing — neoadjuvant-style dosing before TACE — may explain the divergent survival signals.