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.
Year: 2024
Type: conference-abstract
Abstract: 65 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 two 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 . [Table: see text]
Source: Journal of Clinical Oncology
Authors: Masatoshi Kudo, Stephen Lam Chan, Bruno Sangro, 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
Institutions: Kindai University Hospital, Kindai University, Chinese University of Hong Kong, Prince of Wales Hospital, Clinica Universidad de Navarra, Memorial Sloan Kettering Cancer Center, Nanjing General Hospital of Nanjing Military Command, Fudan University, Zhongshan Hospital, National Cancer Centre Japan, Russian Cancer Research Center NN Blokhin, Chang Gung Memorial Hospital, Linkou Chang Gung Memorial Hospital, Hôpital Rangueil, Sichuan University, West China Hospital of Sichuan University, China Medical University, China Medical University Hospital, Hospital de Câncer de Barretos, Willis-Knighton Cancer Center, HCG Cancer Hospital, Healthcare Global Enterprises, AstraZeneca (United States), AstraZeneca (United Kingdom), University of Pisa
Language: English
Subfield: Hepatology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4401514449