Efficacy and Safety of Atezolizumab plus Bevacizumab versus Sorafenib in Hepatocellular Carcinoma with Main Trunk and/or Contralateral Portal Vein Invasion in IMbrave150.

IF 11.6 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Liver Cancer Pub Date : 2024-06-21 eCollection Date: 2024-12-01 DOI:10.1159/000539897

Richard S Finn, Peter R Galle, Michel Ducreux, Ann-Lii Cheng, Norelle Reilly, Alan Nicholas, Sairy Hernandez, Ning Ma, Philippe Merle, Riad Salem, Daneng Li, Valeriy Breder

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引用次数: 0

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 in patient subpopulations with Vp4 portal vein tumor thrombosis (PVTT) and other high-risk prognostic factors are reported.

Methods: IMbrave150 was a global, randomized (2:1), open-label, phase 3 study in systemic treatment-naive patients with unresectable HCC; OS and PFS were co-primary endpoints. Exploratory analyses compared the efficacy and safety of atezolizumab 1,200 mg plus bevacizumab 15 mg/kg every 3 weeks versus sorafenib 400 mg twice daily in patients (i) with and without Vp4 PVTT alone and (ii) with and without high-risk prognostic factors.

Results: In patients with Vp4 PVTT, median OS was 7.6 months (95% CI: 6.0-13.9) with atezolizumab plus bevacizumab (n = 48) and 5.5 months (95% CI: 3.4-6.7) with sorafenib (n = 25; HR 0.62 [95% CI: 0.34-1.11]; descriptive p = 0.104). Median PFS in the respective arms was 5.4 months (95% CI: 3.6-6.9) and 2.8 months (95% CI: 1.5-5.3; HR 0.62 [95% CI: 0.35-1.09]; descriptive p = 0.094). In patients without Vp4, median OS was 21.1 months (95% CI: 18.0-24.6) with atezolizumab plus bevacizumab (n = 288) and 15.4 months (95% CI: 12.6-18.6) with sorafenib (n = 140; HR 0.67 [95% CI: 0.51-0.88]; descriptive p = 0.003). Median PFS in the respective arms was 7.1 months (95% CI: 6.1-9.6) and 4.7 months (95% CI: 4.2-6.1; HR 0.64 [95% CI: 0.51-0.81]; descriptive p < 0.001). The high-risk versus non-high-risk populations had similar outcome patterns. In the respective treatment arms, grade ≥3 treatment-related adverse events occurred in 43% and 48% of patients with Vp4 and 46% and 47% of patients without Vp4.

Conclusion: Regardless of VP4 PVTT or other high-risk features of unresectable HCC, which have often resulted in exclusion from other front-line trials, patients benefited from atezolizumab and bevacizumab versus sorafenib.

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简介在IMbrave150中，阿特珠单抗联合贝伐单抗与索拉非尼相比，可显著改善不可切除肝细胞癌（HCC）患者的总生存期（OS）和无进展生存期（PFS）。报告了Vp4门静脉肿瘤血栓形成（PVTT）和其他高危预后因素患者亚群的疗效和安全性：IMbrave150是一项全球性、随机（2:1）、开放标签的3期研究，研究对象为全身治疗无效的不可切除HCC患者；OS和PFS为共同主要终点。探索性分析比较了atezolizumab 1200毫克加贝伐单抗15毫克/千克每3周一次与索拉非尼400毫克每天两次在(i) 仅有和没有Vp4 PVTT的患者和(ii) 有和没有高危预后因素的患者中的疗效和安全性：在 Vp4 PVTT 患者中，atezolizumab 加贝伐单抗治疗的中位 OS 为 7.6 个月（95% CI：6.0-13.9）（n = 48），索拉非尼治疗的中位 OS 为 5.5 个月（95% CI：3.4-6.7）（n = 25；HR 0.62 [95% CI：0.34-1.11]；描述性 p = 0.104）。两组患者的中位生存期分别为5.4个月（95% CI：3.6-6.9）和2.8个月（95% CI：1.5-5.3；HR 0.62 [95% CI：0.35-1.09]；描述性P = 0.094）。在无Vp4的患者中，阿特珠单抗加贝伐单抗（288人）的中位OS为21.1个月（95% CI：18.0-24.6），索拉非尼（140人）的中位OS为15.4个月（95% CI：12.6-18.6）；HR为0.67 [95% CI：0.51-0.88]；描述性P = 0.003）。两组患者的中位生存期分别为 7.1 个月（95% CI：6.1-9.6）和 4.7 个月（95% CI：4.2-6.1；HR 0.64 [95% CI：0.51-0.81]；描述性 p <0.001）。高危人群与非高危人群的结果模式相似。在各治疗组中，分别有43%和48%的Vp4患者和46%和47%的非Vp4患者发生了≥3级的治疗相关不良事件：无论患者是否具有 VP4 PVTT 或其他不可切除 HCC 的高风险特征（这些特征往往导致患者被排除在其他一线试验之外），阿特珠单抗和贝伐单抗与索拉非尼相比都能使患者获益。

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来源期刊

Liver Cancer Medicine-Oncology

CiteScore

20.80

自引率

7.20%

发文量

审稿时长

16 weeks

期刊介绍： Liver Cancer is a journal that serves the international community of researchers and clinicians by providing a platform for research results related to the causes, mechanisms, and therapy of liver cancer. It focuses on molecular carcinogenesis, prevention, surveillance, diagnosis, and treatment, including molecular targeted therapy. The journal publishes clinical and translational research in the field of liver cancer in both humans and experimental models. It publishes original and review articles and has an Impact Factor of 13.8. The journal is indexed and abstracted in various platforms including PubMed, PubMed Central, Web of Science, Science Citation Index, Science Citation Index Expanded, Google Scholar, DOAJ, Chemical Abstracts Service, Scopus, Embase, Pathway Studio, and WorldCat.