Patterns of radiological progression in participants (pts) with embolization-eligible hepatocellular carcinoma (HCC) treated with durvalumab (D) + bevacizumab (B) + transarterial chemoembolization (TACE) and placebos + TACE: EMERALD-1 post hoc analysis.
Authors: Bruno Sangro, Mohamed Bouattour, Joong-Won Park, Dr. Consuelo Diaz, Joseph P. Erinjeri, Gustavo Vasconcelos Alves, Shan-Zhi Gu, Aleksei Manikhas, Hidekatsu Kuroda, Thatthan Suksombooncharoen, Truc Hoi Trung Vo, Vikas S. Ostwal, Melissa A. Eastgate, Gina M. Vaccaro, Rebecca Griffin, Sajid Ali, Kavitha Balaji, Stephen Lam Chan
Journal: Journal of Clinical Oncology (2025)

574 Background: EMERALD-1 (NCT03778957) met its primary endpoint, demonstrating improved progression-free survival (PFS) in pts with locoregional HCC treated with D + B + TACE versus placebos (PBO) + TACE (stratified Cox proportional hazards hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.61–0.98 [Lencioni R, et al. J Clin Oncol 2024;42(suppl 3). Abs LBA432]). This post hoc analysis assessed outcomes by radiological progression pattern in pts treated with D + B + TACE or PBO + TACE. Methods: Pts included in this analysis received D (1500 mg) or PBO for D (Q4W) in combination with conventional (c)- or drug-eluting bead (DEB)-TACE (investigator choice, 1–4 TACE procedures within 16 weeks). Subsequently, pts received D (1120 mg) + B (15 mg/kg), or PBO for D + B (Q3W). This study analyzed radiological progression patterns at the time of first progressive disease (PD) as assessed by the investigator per modified Response Evaluation Criteria in Solid Tumors. A new lesion was classified as a new intrahepatic lesion (NIH) or new extrahepatic lesion (NEH); tumor growth of existing intrahepatic lesions (increase of ≥20% of an existing target lesion with at least &gt;5 mm absolute increase or unequivocal PD with a non-target lesion) was classified as intrahepatic growth (IHG; categories were not mutually exclusive). Efficacy was assessed by time to progression (TTP). Results: In the D + B + TACE arm, 53.9% of pts had PD, and in the PBO + TACE arm 79.0% of pts had PD. The most common pattern of disease progression across both treatment arms was NIH, occurring in 73 (35.8%) and 107 (52.2%) pts in the D + B + TACE and PBO + TACE arms, respectively, with 31 (15.2%) and 34 (16.6%) pts exhibiting IHG, and 24 (11.8%) and 39 (19.0%) pts exhibiting NEH, respectively. Improved TTP was observed in pts treated with D + B + TACE versus PBO + TACE, regardless of progression pattern (Table). Conclusions: Overall, the rate of progression was lower with D + B + TACE compared with PBO + TACE. The pattern of disease progression observed with D + B + TACE and PBO + TACE was similar, with NIH the most common pattern of progression in both treatment arms. Consistent benefit in TTP was observed with D + B + TACE versus PBO + TACE, regardless of progression pattern. Clinical trial information: NCT03778957 . NIH IHG NEH D + B + TACE (n=73) PBO + TACE (n=107) D + B + TACE (n=31) PBO + TACE (n=34) D + B + TACE (n=24) PBO + TACE (n=39) Median (95% CI) TTP, months 13.7 (10.8–16.5) 8.8 (7.0–10.9) 5.1 (3.0–9.0) 4.3 (2.9–4.8) 6.7 (2.8–16.6) 4.6 (2.9–6.8) HR (95% CI)* 0.78 (0.57–1.07) 0.61 (0.36–1.03) 0.66 (0.36–1.15) *HR and CI were estimated using a Cox proportional hazards model, the CI was calculated using a profile likelihood approach.