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.

Abstract

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.