Updated efficacy and safety data from IMbrave150: Atezolizumab plus bevacizumab vs. sorafenib for unresectable hepatocellular carcinoma
Updated efficacy and safety data from IMbrave150: Atezolizumab plus bevacizumab vs. sorafenib for unresectable hepatocellular carcinoma
复制标题
DOI：
10.1016/j.jhep.2021.11.030
复制
发表时间：
2022-03-15
影响因子：
25.7
通讯作者：
Finn, Richard S.
中科院分区：
文献类型：
--
作者：
Cheng, Ann-Lii;Qin, Shukui;Finn, Richard S.
背景和目标：IMbrave 150证明，在主要分析时（中位随访8.6个月后），atezolizumab联合贝伐珠单抗与索拉非尼相比，显著改善了不可切除肝细胞癌患者的总生存期（OS）和无进展生存期（PFS）。我们目前更新的数据后12个月的额外follow-updated.Methods：全身治疗初治，不可切除的肝细胞癌患者随机2：1接受1,200毫克atezolizumab加15毫克/公斤贝伐单抗静脉注射每3周或400毫克索拉非尼口服每日两次在这个开放标签，III期研究。在意向治疗人群中，联合主要终点为独立评估的RECIST 1.1的OS和PFS。次要疗效终点包括客观缓解率和探索性亚组疗效分析。结果：从2018年3月15日至2019年1月30日，501例患者（意向治疗人群）被随机分配接受atezolizumab+贝伐珠单抗（n = 336）或索拉非尼（n = 165）。2020年8月31日，在中位15.6（范围，0-28.6）个月的随访后，atezolizumab+贝伐珠单抗的中位OS为19.2个月（95%CI 17.0-23.7），索拉非尼为13.4个月（95%CI 11.4-16.9）（风险比[HR] 0.66; 95%CI 0.52-0.85;描述性p
Background & Aims: IMbrave150 demonstrated that atezolizumab plus bevacizumab led to significantly improved overall survival (OS) and progression-free survival (PFS) compared with sorafenib in patients with unresectable hepatocellular carcinoma at the primary analysis (after a median 8.6 months of follow-up). We present updated data after 12 months of additional follow-up.Methods: Patients with systemic treatment-naive, unresectable hepatocellular carcinoma were randomized 2:1 to receive 1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks or 400 mg sorafenib orally twice daily in this open-label, phase III study. Co-primary endpoints were OS and PFS by independently assessed RECIST 1.1 in the intention-to-treat population. Secondary efficacy endpoints included objective response rates and exploratory subgroup efficacy analyses. This is a post hoc updated analysis of efficacy and safety.Results: From March 15, 2018, to January 30, 2019, 501 patients (intention-to-treat population) were randomly allocated to receive atezolizumab plus bevacizumab (n = 336) or sorafenib (n = 165). On August 31, 2020, after a median 15.6 (range, 0-28.6) months of followup, the median OS was 19.2 months (95% CI 17.0-23.7) with atezolizumab plus bevacizumab and 13.4 months (95% CI 11.4-16.9) with sorafenib (hazard ratio [HR] 0.66; 95% CI 0.52-0.85; descriptive p