Atezolizumab plus Bevacizumab versus Sorafenib in the Chinese Subpopulation with Unresectable Hepatocellular Carcinoma: Phase 3 Randomized, Open-Label IMbrave150 Study
Journal
Liver Cancer
Journal Volume
10
Journal Issue
4
Pages
296-308
Date Issued
2021
Author(s)
Qin S.
Ren Z.
Feng Y.-H.
Yau T.
Wang B.
Zhao H.
Bai Y.
Gu S.
Li L.
Hernandez S.
Xu D.-Z.
Mulla S.
Wang Y.
Shao H.
Abstract
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. ? 2021 The Author(s) Published by S. Karger AG, Basel.
Subjects
Checkpoint inhibitor; Chinese patients; Immunotherapy; Liver cancer; Overall survival; Programmed death-ligand 1 inhibitor; Systemic treatment
SDGs
Other Subjects
alanine aminotransferase; alcohol; alkaline phosphatase; antineoplastic agent; aspartate aminotransferase; atezolizumab; bevacizumab; bilirubin; gamma glutamyltransferase; lactate dehydrogenase; protein tyrosine kinase inhibitor; sorafenib; abdominal pain; adult; aged; alanine aminotransferase blood level; alkaline phosphatase blood level; alopecia; Article; artificial embolization; aspartate aminotransferase blood level; bilirubin blood level; body weight loss; brain hemorrhage; cancer patient; cancer survival; chemoembolization; chemotherapy induced anemia; chemotherapy induced emesis; chemotherapy induced nausea; China; Chinese; comparative effectiveness; constipation; controlled study; decreased appetite; diarrhea; drug dose reduction; drug efficacy; drug eruption; drug fatality; drug safety; drug withdrawal; fatigue; female; fever; gamma glutamyl transferase blood level; gastrointestinal hemorrhage; hand foot syndrome; hazard ratio; human; hypertension; hypoalbuminemia; hypokalemia; hypophosphatemia; hypothyroidism; infusion related reaction; injection; inoperable cancer; intention to treat analysis; lactate dehydrogenase blood level; leukocyte count; leukopenia; liver cell carcinoma; liver dysfunction; major clinical study; male; multicenter study; multimodality cancer therapy; neutropenia; open study; overall survival; phase 3 clinical trial; pneumonia; progression free survival; proteinuria; pruritus; radioembolization; radiofrequency ablation; randomized controlled trial; response evaluation criteria in solid tumors; risk assessment; side effect; systemic therapy; thrombocytopenia; treatment duration; upper gastrointestinal bleeding
Publisher
S. Karger AG
Type
journal article