PMID- 34414118 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220425 IS - 2235-1795 (Print) IS - 1664-5553 (Electronic) IS - 1664-5553 (Linking) VI - 10 IP - 4 DP - 2021 Jul TI - Atezolizumab plus Bevacizumab versus Sorafenib in the Chinese Subpopulation with Unresectable Hepatocellular Carcinoma: Phase 3 Randomized, Open-Label IMbrave150 Study. PG - 296-308 LID - 10.1159/000513486 [doi] AB - INTRODUCTION: Atezolizumab plus bevacizumab significantly improved overall survival (OS) and progression-free survival (PFS) versus sorafenib in patients with unresectable hepatocellular carcinoma (HCC) in IMbrave150. Efficacy and safety data from the Chinese subpopulation are reported. METHODS: IMbrave150, a global, randomized, open-label, phase 3 study in patients with systemic treatment-naive unresectable HCC, included an extension phase that enrolled additional patients from mainland China. Patients were randomized (2:1) to receive intravenous atezolizumab 1,200 mg plus bevacizumab 15 mg/kg once every 3 weeks or sorafenib 400 mg twice a day until unacceptable toxicity or loss of clinical benefit. Co-primary endpoints were OS and independent review facility-assessed PFS per Response Evaluation Criteria in Solid Tumors version 1.1 in the intention-to-treat population. RESULTS: Of 194 Chinese patients enrolled from April 16, 2018, to April 8, 2019 (137 in the global study and 57 in the China extension phase), 133 received atezolizumab plus bevacizumab and 61 received sorafenib. At the data cutoff (August 29, 2019), the stratified hazard ratio for OS was 0.44 (95% CI, 0.25-0.76) and for PFS was 0.60 (95% CI, 0.40-0.90). The respective median OS and PFS with atezolizumab plus bevacizumab were not reached (NR; 95% CI, 13.5 months to NR) and 5.7 months (95% CI, 4.2-8.3) versus 11.4 months (95% CI, 6.7 to NR) and 3.2 months (95% CI, 2.6-4.8) with sorafenib. Grade 3-4 adverse events (AEs) occurred in 78 of 132 (59.1%) atezolizumab plus bevacizumab-treated and 27 of 58 (46.6%) sorafenib-treated patients. The most common grade 3-4 AE with atezolizumab plus bevacizumab was hypertension, occurring in 15.2% of patients; however, other high-grade AEs were infrequent. CONCLUSION: Clinically meaningful improvements in OS and PFS observed with atezolizumab plus bevacizumab versus sorafenib suggest that atezolizumab plus bevacizumab may become a practice-changing treatment for Chinese patients with unresectable HCC. CI - Copyright (c) 2021 by S. Karger AG, Basel. FAU - Qin, Shukui AU - Qin S AD - People's Liberation Army Cancer Center, Jinling Hospital, Nanjing, China. FAU - Ren, Zhenggang AU - Ren Z AD - Liver Cancer Institute and Department of Liver Cancer Surgery, Zhongshan Hospital, Fudan University, Shanghai, China. FAU - Feng, Yin-Hsun AU - Feng YH AD - Department of Internal Medicine, Chi Mei Medical Center, Tainan, Taiwan. FAU - Yau, Thomas AU - Yau T AD - Department of Medicine, Haematology, Medical Oncology & Bone Marrow Transplantation Division, Queen Mary Hospital, Hong Kong, China. FAU - Wang, Baocheng AU - Wang B AD - Department of Oncology, General Hospital of Jinan Military Command, Jinan, China. FAU - Zhao, Haitao AU - Zhao H AD - Department of Liver Surgery, Peking Union Medical College Hospital, Beijing, China. FAU - Bai, Yuxian AU - Bai Y AD - Department of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin, China. FAU - Gu, Shanzhi AU - Gu S AD - Radioactive Interventional Department, Hunan Cancer Hospital, Changsha, China. FAU - Li, Lindong AU - Li L AD - Product Development Oncology, Roche (China) Holding Ltd., Shanghai, China. FAU - Hernandez, Sairy AU - Hernandez S AD - Medical Affairs, Genentech, Inc., South San Francisco, California, USA. FAU - Xu, Derek-Zhen AU - Xu DZ AD - Product Development Oncology, Roche (China) Holding Ltd., Shanghai, China. FAU - Mulla, Sohail AU - Mulla S AD - Product Development Biometrics, Hoffmann-La Roche Ltd., Mississauga, Ontario, Canada. FAU - Wang, Yifan AU - Wang Y AD - Product Development Oncology, Roche (China) Holding Ltd., Shanghai, China. FAU - Shao, Hui AU - Shao H AD - Product Development Oncology, Roche (China) Holding Ltd., Shanghai, China. FAU - Cheng, Ann Lii AU - Cheng AL AD - Department of Medical Oncology, National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei, Taiwan. LA - eng PT - Journal Article DEP - 20210423 PL - Switzerland TA - Liver Cancer JT - Liver cancer JID - 101597993 PMC - PMC8339481 OTO - NOTNLM OT - Checkpoint inhibitor OT - Chinese patients OT - Immunotherapy OT - Liver cancer OT - Overall survival OT - Programmed death-ligand 1 inhibitor OT - Systemic treatment COIS- T.Y. has received honoraria from Bristol Myers Squibb and MSD Oncology and served in a consulting or advisory role for Bristol Myers Squibb. L.L. is an employee of Roche. S.H. is an employee of Genentech. D.-Z.X. is an employee of Roche. S.M. is an employee of, and owns stock in, F. Hoffmann-La Roche. Y.W. is an employee of Roche. H.S. is an employee of Roche. A.-L.C. has received honoraria from AstraZeneca, Bayer Yakuhin, Eisai, Genentech/Roche, and Lilly, and has served in a consulting or advisory role for AstraZeneca; Bayer Schering Pharma; BeiGene; Bristol Myers Squibb; CSR Pharma Group; Eisai; Genentech/Roche; IQVIA; MSD; Novartis; and Ono Pharmaceutical. Others claimed no conflicts of interest. A.-L.C. is an associate editor of the journal Liver Cancer. EDAT- 2021/08/21 06:00 MHDA- 2021/08/21 06:01 PMCR- 2021/04/23 CRDT- 2021/08/20 07:06 PHST- 2020/07/24 00:00 [received] PHST- 2020/11/28 00:00 [accepted] PHST- 2021/08/20 07:06 [entrez] PHST- 2021/08/21 06:00 [pubmed] PHST- 2021/08/21 06:01 [medline] PHST- 2021/04/23 00:00 [pmc-release] AID - lic-0010-0296 [pii] AID - 10.1159/000513486 [doi] PST - ppublish SO - Liver Cancer. 2021 Jul;10(4):296-308. doi: 10.1159/000513486. Epub 2021 Apr 23.