Introduction The phase III IMbrave150 study established atezolizumab + bevacizumab as standard of care in patients with unresectable hepatocellular carcinoma (HCC). This exploratory analysis reports efficacy and safety results in patients with baseline Barcelona Clinic Liver Cancer (BCLC) stage B disease. Methods Patients with systemic treatment-naive unresectable HCC and Child-Pugh class A liver function were randomized 2:1 to receive 1,200 mg of atezolizumab plus 15 mg/kg of bevacizumab or 400 mg of sorafenib. Co-primary endpoints were overall survival (OS) and progression-free survival (PFS) per independent review facility (IRF)-assessed Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in the BCLC stage B subgroup. Patients in this analysis had BCLC stage B disease at baseline per electronic case report form. Secondary efficacy endpoints included the objective response rate (ORR) and change in the sum of longest diameters (SLD) of target lesions from baseline per IRF RECIST 1.1 and modified RECIST (mRECIST) for HCC. Results Of 501 enrolled patients, 74 (15%) had BCLC stage B disease at baseline (atezolizumab + bevacizumab, n = 49; sorafenib, n = 24). For this group, median follow-up was 19.7 months. A trend toward improved OS and PFS per IRF RECIST 1.1 was observed with atezolizumab + bevacizumab versus sorafenib (OS: hazard ratio [HR]: 0.63; 95% confidence interval [CI]: 0.29, 1.34; PFS: HR: 0.64; 95% CI: 0.36, 1.12). ORRs per IRF RECIST 1.1 and HCC mRECIST were 43% and 50% with atezolizumab + bevacizumab and 26% and 30% with sorafenib, respectively. Percentage change in SLD of target lesions from baseline per IRF RECIST 1.1 and HCC mRECIST showed durable responses with atezolizumab + bevacizumab treatment. Safety data were consistent with known profiles of atezolizumab and bevacizumab, as seen in the overall study population. Discussion/Conclusion Efficacy benefits were observed with atezolizumab + bevacizumab in patients with baseline BCLC stage B disease, consistent with the intention-to-treat population.

中文翻译：

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IMbrave150：Atezolizumab 加贝伐单抗与索拉非尼在巴塞罗那临床 B 期肝癌不可切除肝细胞癌患者中的疗效和安全性：III 期研究的探索性分析。

简介 III 期 IMbrave150 研究将 atezolizumab + 贝伐单抗确立为不可切除的肝细胞癌 (HCC) 患者的标准治疗方法。这项探索性分析报告了基线巴塞罗那临床肝癌 (BCLC) B 期疾病患者的疗效和安全性结果。方法 将未接受全身治疗且肝功能 Child-Pugh A 级的患者以 2:1 的比例随机分配，接受 1,200 mg 阿特珠单抗加 15 mg/kg 贝伐珠单抗或 400 mg 索拉非尼治疗。共同主要终点是根据独立审查机构 (IRF) 评估的 BCLC B 期亚组实体瘤疗效评估标准 (RECIST) 1.1 版的总生存期 (OS) 和无进展生存期 (PFS)。根据电子病例报告表，本分析中的患者在基线时患有 BCLC B 期疾病。次要疗效终点包括客观缓解率 (ORR) 以及根据 IRF RECIST 1.1 和 HCC 改良 RECIST (mRECIST) 目标病灶最长直径总和 (SLD) 相对于基线的变化。结果 501 名入组患者中，74 名 (15%) 基线时患有 BCLC B 期疾病（阿特珠单抗 + 贝伐珠单抗，n = 49；索拉非尼，n = 24）。该组的中位随访时间为 19.7 个月。根据 IRF RECIST 1.1，观察到阿特珠单抗 + 贝伐单抗与索拉非尼相比，OS 和 PFS 有改善的趋势（OS：风险比 [HR]：0.63；95% 置信区间 [CI]：0.29, 1.34；PFS：HR：0.64；95%置信区间：0.36，1.12）。根据 IRF RECIST 1.1 和 HCC mRECIST，阿特珠单抗 + 贝伐单抗的 ORR 分别为 43% 和 50%，索拉非尼的 ORR 分别为 26% 和 30%。根据 IRF RECIST 1.1 和 HCC mRECIST，目标病变 SLD 相对于基线的百分比变化显示阿特朱单抗 + 贝伐单抗治疗的持久缓解。正如在整个研究人群中所见，安全性数据与阿特珠单抗和贝伐单抗的已知概况一致。讨论/结论 在基线 BCLC B 期疾病患者中观察到阿特朱单抗 + 贝伐单抗的疗效获益，与意向治疗人群一致。