Meeting
2024 ASCO Annual Meeting
Safety analysis by treatment periods from EMERALD-1: A phase 3, randomized, placebo-controlled study of transarterial chemoembolization with durvalumab with/without bevacizumab in participants with embolization-eligible unresectable hepatocellular carcinoma.
Authors
Stephen Lam Chan
Department of Clinical Oncology, Prince of Wales Hospital, Sir Yue-Kong Pao Center for Cancer, The Chinese University of Hong Kong, Hong Kong SAR, China
Stephen Lam Chan , Bruno Sangro , Masatoshi Kudo , Joseph P. Erinjeri , Shukui Qin , Zhenggang Ren , Yasuaki Arai , Valeriy Vladimirovich Breder , Shi-Ming Lin , Jean-Marie Peron , Tien Quang Nguyen , Lunan Yan , Chang-Fang Chiu , Florinda A. Santos , Anil Veluvolu , Satheesh Chiradoni Thungappa , Claire Morgan , Kerry Parsons , Ioannis Xynos , Riccardo Lencioni
Organizations
Department of Clinical Oncology, Prince of Wales Hospital, Sir Yue-Kong Pao Center for Cancer, The Chinese University of Hong Kong, Hong Kong SAR, China, Liver Unit and HPB Oncology Area, Clínica Universidad de Navarra and CIBEREHD, Pamplona, Spain, Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan, Interventional Radiology Service, Memorial Sloan Kettering Cancer Center, New York, NY, Cancer Center of Nanjing, Jinling Hospital, Nanjing, China, Department of Hepatic Oncology, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China, Department of Diagnostic Radiology, National Cancer Center, Chuo-Ku, Tokyo, Japan, Department of Chemotherapy, N. N. Blokhin National Medical Research Center of Oncology, Moscow, Russian Federation, Department of Internal Medicine, Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan, Taiwan, Hepatology Unit, Rangueil University Hospital, Toulouse, France, Department of Medical Oncology, National Cancer Hospital, Hanoi, Viet Nam, Liver Transplantation Center, Department of Liver Surgery, West China Hospital of Sichuan University, Chengdu, Sichuan, China, Cancer Center and Division of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan, Department of Oncology, Barretos Cancer Hospital, Barretos, Brazil, Willis-Knighton Hematology/Oncology, A Department of Willis-Knighton Medical Center, Shreveport, LA, Department of Medical Oncology, HCG Oncology, Bangalore, India, Global Patient Safety Oncology, AstraZeneca, Gaithersburg, MD, Oncology R&D, Late-Stage Development, AstraZeneca, Gaithersburg, MD, Oncology R&D, Late-Stage Development, AstraZeneca, Cambridge, United Kingdom, Department of Diagnostic and Interventional Radiology, University of Pisa School of Medicine, Pisa, Italy
Research Funding
AstraZeneca
Background: The global Phase 3 EMERALD-1 study (NCT03778957) primary endpoint was met: durvalumab (D) + bevacizumab (B) + transarterial chemoembolization (TACE) significantly improved progression-free survival vs placebos (pbos)+TACE (median 15.0 vs 8.2 mo; HR 0.77; 95% CI 0.61–0.98; p=0.032 [threshold 0.0435]) in participants (pts) with embolization-eligible unresectable hepatocellular carcinoma (uHCC) with a manageable safety profile. This post hoc, exploratory analysis assessed safety in the study’s 2 treatment (tx) periods (pds): D-TACE (D-T) and D-B. Methods: Pts were randomized 1:1:1 to D+TACE, D+B+TACE, or pbos+TACE. In the D-T pd, pts received 1–4 TACE (cTACE or DEB-TACE [investigator choice]) plus D (1500 mg Q4W) or pbo for D. In the D-B pd, post-last TACE, pts received D (1120 mg Q3W) plus pbo for B, D (1120 mg Q3W) plus B (15 mg/kg Q3W), or pbos for D and B. Adverse events (AEs), start/end date, maximum/change in CTCAE grade, and causality were assessed in the D-T and D-B pds in pts who received any study tx in the arm to which they were randomized, until end of follow-up. Results: The Table shows duration of exposure (DoE). In the D+TACE, D+B+TACE, and pbos+TACE arms, AEs were reported by 144 (74.6%), 139 (72.0%), and 148 (74.0%) pts in the D-T pd and 133 (68.9%), 147 (76.2%), and 132 (66.0%) pts in the D-B pd; were possibly related (pos rel) to study tx in 59 (30.6%), 56 (29.0%), and 41 (20.5%) pts in the D-T pd and 76 (39.4%), 114 (59.1%), and 69 (34.5%) pts in the D-B pd; and were provoked by TACE in 72 (37.3%), 90 (46.6%), and 85 (42.5%) pts in the D-T pd and 16 (8.3%), 18 (9.3%), and 21 (10.5%) pts in the D-B pd, respectively. Conclusions: D+B+TACE had a manageable safety profile across the D-T and D-B pds, consistent with the individual agents and underlying disease.These data further support D+B+TACE as a new potential standard of care in embolization-eligible uHCC. Clinical trial information: NCT03778957.
| D+TACE D-T pd (n=193) | D+B+TACE D-T pd (n=193) | Pbos+TACE D-T pd (n=200) | D+TACE D-B pd (n=193) | D+B+TACE D-B pd (n=193) | Pbos+TACE D-B pd (n=200) | |
|---|---|---|---|---|---|---|
| Median (range) DoE to D or pbo; to B or pbo, months | 2.76 (0.2–30.8) | 2.76 (0.2–25.3) | 2.76 (0.9–26.1) | 6.93 (0.7–45.5); 6.92 (0.7–45.5) | 10.51 (0.3–38.1); 9.35 (0.3–36.5) | 8.31 (0.7–43.0); 8.31 (0.7–43.0) |
| Any AE, n (%) | ||||||
| Max Grade 3/4 | 29 (15.0) | 29 (15.0) | 26 (13.0) | 36 (18.7) | 60 (31.1) | 22 (11.0) |
| Pos rel to study tx, max Grade 3/4* | 4 (2.1) | 6 (3.1) | 4 (2.0) | 10 (5.2) | 38 (19.7) | 8 (4.0) |
| With outcome of death | 9 (4.7) | 6 (3.1) | 5 (2.5) | 6 (3.1) | 16 (8.3) | 6 (3.0) |
| Pos rel to study tx* | 0 | 2 (1.0)† | 1 (0.5)† | 1 (0.5)‡ | 0 | 2 (1.0)‡ |
| Provoked by TACE | 0 | 0 | 1 (0.5) | 0 | 0 | 0 |
| Leading to discontinuation of study tx | 11 (5.7) | 7 (3.6) | 5 (2.5) | 13 (6.7) | 42 (21.8) | 10 (5.0) |
| Pos rel to study tx* | 1 (0.5) | 3 (1.6) | 2 (1.0) | 5 (2.6) | 18 (9.3) | 4 (2.0) |
*Excluding TACE.
†Pos rel to D or placebo for D.
‡Pos rel to B or placebo for B.
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Abstract Details
Session Type
Poster Session
Session Title
Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Track
Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Sub Track
Hepatobiliary Cancer - Local-Regional Disease
Clinical Trial Registration Number
NCT03778957
Citation
J Clin Oncol 42, 2024 (suppl 16; abstr 4122)
DOI
10.1200/JCO.2024.42.16_suppl.4122
Abstract #
4122
Poster Bd #
102
Abstract Disclosures
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