Outcomes by key prognostic factors in EMERALD-1: a Phase 3 study of durvalumab ± bevacizumab with transarterial chemoembolization (TACE) in participants with embolization-eligible unresectable hepatocellular carcinoma (uHCC)

Tuesday, April 1, 2025

4:03 PM – 4:12 PM CT

Location: Music City Center, 209 ABC

Presenting Author(s)

Nadine Abi-Jaoudeh, MD, FSIR

Professor of Radiology
University of California, United States

Author/Co-author(s)

MK

Masatoshi Kudo, MD, PhD

Professor and Chairman Department of Gastroenterology and Hepatology
Kindai University Faculty of Medicine, Japan
SC

Stephen L. Chan, MD

N/A
Department of Clinical Oncology, Prince of Wales Hospital, Sir Yue-Kong Pao Center for Cancer, The Chinese University of Hong Kong, China (People's Republic)
RL

Riccardo Lencioni, MD

N/A
Department of Diagnostic and Interventional Radiology, University of Pisa School of Medicine, Italy
TD

Thomas Decaens, MD, PhD

Professor of Medecine
Université Grenoble Alpes, INSERM U1209, France
JE

Joseph P. Erinjeri, MD PhD

Attending
Memorial Sloan Kettering Cancer Center, United States
SQ

Shukui Qin, MD

N/A
Cancer Center of Nanjing, Jinling Hospital, China (People's Republic)
ZR

Zhenggang Ren, PhD

Department of Liver Surgery
Zhongshan Hospital, Fudan University, China (People's Republic)
MB

Mohamed Bouattour, MD

N/A
AP-HP Hôpital Beaujon, Liver Cancer and Innovative Therapy, France
Yasuaki Arai, MD, FSIR

Guest researcher
National Cancer Center Hospital, Japan
JH

Jeong Heo, MD

N/A
Department of Internal Medicine, College of Medicine, Pusan National University and Biomedical Research Institute, Pusan National University Hospital, Republic of Korea
VB

Valeriy V. Breder, MD

N/A
Department of Chemotherapy, N. N. Blokhin National Medical Research Center of Oncology, Russia
Farshid Dayyani, MD, PhD (he/him/his)

Professor of Clinical Medicine
University of California Irvine, United States
AA

Alejandro Molina Alavez, MD

N/A
Medical Oncology Department, Oncology Clinical Research and Care Center, Mexico
JP

Joong-Won Park, MD, PhD

Adjunct Professor
National Cancer Center, Republic of Korea
JY

Jung-Hwan Yoon, MD

N/A
Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Republic of Korea
KK

Kwong-Ming Kee, MD

N/A
Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Taiwan (Republic of China)
TS

Tanita Suttichaimongkol, MD

N/A
Division of Gastroenterology and Hepatology, Department of Medicine, Faculty of Medicine, Khon Kaen University, Thailand
YI

Yoshitaka Inaba, n/a

Professor
Aichi Cancer Center Hospital, Japan
RG

Rebecca Griffin, None

N/A
Oncology Biometrics, Late Oncology Statistics, AstraZeneca, United Kingdom
MZ

Magdalena Zotkiewicz, None

N/A
Oncology Biometrics, Late Oncology Statistics, AstraZeneca, Poland
CM

Claire Morgan, None

N/A
Global Patient Safety Oncology, AstraZeneca, United States
SA

Sajid Ali, None

N/A
Global Medicines Development, AstraZeneca, United Kingdom
KB

Kavitha Balaji, None

N/A
Global Medical Affairs, AstraZeneca, United States
BS

Bruno Sangro, MD, PhD

Director of the Liver Unit
Clinica Universidad de Navarra and CIBEREHD, Spain

Purpose:

EMERALD-1 (NCT03778957) demonstrated a significant improvement in progression-free survival (PFS) for durvalumab (D) + bevacizumab (B) + TACE vs placebos (PBOs) + TACE in participants (pts) with embolization-eligible uHCC{1}. The population for embolization-eligible uHCC is heterogenous, with outcomes in HCC influenced by key prognostic factors, such as liver function or tumor burden. Here, we assessed outcomes by baseline liver function, as measured by albumin-bilirubin (ALBI) grade (gr), and by baseline tumor burden, based on tumor number and diameter as measured by the up-to-7 criterion.

Materials and Methods:

EMERALD-1 study design has been presented{1}. This exploratory analysis included pts treated with D + B + TACE and PBOs + TACE (herein TACE). PFS and time to progression (TTP; BICR RECIST 1.1) in the intent-to-treat (ITT) population and safety in the safety analysis set (pts received ≥1 dose of study treatment [tx], regardless of randomization) are reported by baseline liver function (ALBI gr 1 or 2; no pts had ALBI gr 3) or tumor burden (within [≤7] or beyond [ >7] up-to-7 criterion).

Results: PFS and TTP improved with D + B + TACE vs TACE in the ALBI gr 1 and 2, and the ≤7 and >7 groups (Table). Max. gr 3–4 tx-related adverse event rates were higher with D + B + TACE vs TACE, regardless of baseline liver function (ALBI gr 1: 27.8% vs 5.7%; ALBI gr 2: 25.0% vs 6.5%) or baseline tumor burden (≤7: 24.4% vs 9.1%; >7: 29.2% vs 3.0%); differences were reduced when adjusted for duration of exposure (event rate per 100 pt year, ALBI gr 1: 17.3 vs 4.7; ALBI gr 2: 20.2 vs 6.4; tumor burden ≤7: 15.9 vs 6.5; >7: 21.6 vs 3.4). No tx‑related deaths with D + B + TACE were observed.

Conclusion: PFS and TTP benefits were observed with D + B + TACE vs TACE with manageable safety, regardless of baseline liver function or baseline tumor burden. Data support a favorable risk‑benefit profile with D + B + TACE in embolization-eligible uHCC.