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.
Authors: Jeong Heo, Takuji Okusaka, Jung-Hwan Yoon, Bruno Sangro, Stephen Lam Chan, Joseph P. Erinjeri, Marco Matos, Thomas Decaens, Eric Xueyu Chen, Muhammad S. Beg, Ana Maria Matilla, Le Thi Tuyet Phuong, Rebecca Griffin, Stephanie I. Udoye, Sandra Indiviglio, Masatoshi Kudo
Journal: Journal of Clinical Oncology (2025)

575 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. Clinical trial information: NCT03778957 . D + B and cTACE (n=121) PBO and cTACE (n=120) D + B and DEB-TACE (n=83) PBO and DEB-TACE (n=85) Median (95% CI) PFS, months 19.4 (12.4–22.3) 11.1 (7.2–14.0) 11.1 (7.2–14.2) 6.7 (5.0–7.3) PFS HR (95% CI) 0.80 (0.59–1.10) 0.74 (0.51–1.06) Median (95% CI) TTP, months 22.3 (19.4–27.7) 13.6 (9.2–16.6) 15.0 (11.1–22.4) 6.9 (5.1–11.1) TTP HR (95% CI) 0.70 (0.49–0.98) 0.55 (0.36–0.83) Pts with measurable disease at baseline, n 119 119 83 84 ORR, n (%) pts with response* 62 (52.1) 43 (36.1) 26 (31.3) 17 (20.2) ORR, odds ratio (95% CI) 1.93 (1.15–3.27) 1.80 (0.89–3.69) *Includes confirmed complete or partial response.