Outcomes by transarterial chemoembolization (TACE) modality from participants (pts) with embolization-eligible hepatocellular carcinoma (HCC) treated with durvalumab (D)+bevacizumab (B)+TACE and placebos (PBO)+TACE: EMERALD-1 subgroup analysis

Background: EMERALD-1 (NCT03778957) met its primary endpoint, showing improved progression-free survival (PFS) in pts with locoregional HCC treated with D+B+TACE versus PBO+TACE (hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.61–0.98). This analysis assessed the impact of TACE modality (conventional TACE [cTACE] or drug-eluting bead [DEB]-TACE) on efficacy and safety outcomes.

Methods: Pts in this analysis received D (1500 mg) or PBO for D (Q4W) plus cTACE or DEB-TACE (investigator choice; TACE modality was a stratification factor). After completing the last TACE, pts received D (1120 mg)+B (15 mg/kg) or PBO for D+B (Q3W). PFS, time to progression (TTP), and overall response rate (ORR; BICR per RECIST v1.1) with D+B+TACE and PBO+TACE (intent-to-treat population) are reported by TACE modality. Safety was assessed in the safety analysis set (pts received≥1 dose of study treatment [tx], regardless of randomization).

Results: Overall, 59.3% of pts received cTACE and 40.7% received DEB-TACE in the D+B+TACE arm; similarly, 58.5% of pts received cTACE and 41.5% received DEB-TACE in the PBO+TACE arm. Most pts received 1 or 2 TACE procedures in both cTACE (60% in D+B+TACE arm; 67.2% in PBO+TACE arm) and DEB-TACE groups (55.6% in D+B+TACE arm; 53.6% in PBO+TACE arm). Baseline characteristics in the cTACE and DEB-TACE groups were similar, with some differences in the relative distribution of BCLC, HAP, and tumor burden (BCLC Score A; 29.0% vs 17.9%: HAP Score A; 36.5% vs 25.0%: tumor burden within up-to-7 criteria; 56.4% vs 37.5%, respectively). Baseline characteristics were generally well balanced across tx arms within the cTACE and DEB-TACE groups. PFS, TTP, and ORR improved with D+B+TACE versus PBO+TACE, regardless of TACE modality (Table). In the D+B+TACE and PBO+TACE arms, max Grade 3–4 adverse events possibly related to study tx were reported by 25/100 (25.0%) and 3/116 (2.6%) pts in the cTACE group, and 16/54 (29.6%) and 9/84 (10.7%) pts in the DEB-TACE group, respectively.

Conclusions: Overall, pts receiving D+B+TACE had improved PFS, TTP, and ORR versus PBO+TACE regardless of TACE modality. Safety was manageable with both cTACE and DEB-TACE.

© 2025 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2025 Gastrointestinal Cancers Symposium. All rights reserved.

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Artikel online veröffentlicht:
04. September 2025