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 1200 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 objective response rate (ORR) and change in the sum of longest diameter (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 vs sorafenib (OS: HR, 0.63; 95% 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 加贝伐珠单抗与索拉非尼在巴塞罗那临床肝癌 B 期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 + 贝伐珠单抗确立为无法切除的肝细胞癌 (HCC) 患者的标准治疗。该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：未接受过全身治疗且肝功能 Child-Pugh A 级的 HCC 患者按 2:1 的比例随机接受 1200 mg atezolizumab 加 15 mg/kg 贝伐珠单抗或 400 mg 索拉非尼。根据独立审查机构 (IRF) 评估的 BCLC B 期亚组实体瘤反应评估标准 (RECIST) 1.1 版，共同主要终点是总生存期 (OS) 和无进展生存期 (PFS)。根据电子病例报告表，该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）和目标病灶最长直径总和（SLD）相对于基线的变化（根据 IRF RECIST 1.1 和针对 HCC 的改良 RECIST（mRECIST））。结果：在 501 名入组患者中，74 名 (15%) 在基线时患有 BCLC B 期疾病（atezolizumab + 贝伐珠单抗，n=49；索拉非尼，n=24）。对于该组，中位随访时间为 19.7 个月。根据 IRF RECIST 1.1，观察到 atezolizumab + 贝伐珠单抗与索拉非尼相比有改善 OS 和 PFS 的趋势（OS：HR，0.63；95% CI：0.29，1.34；PFS：HR，0.64；95% CI：0.36，1.12）。根据 IRF RECIST 1.1 和 HCC mRECIST，阿特珠单抗 + 贝伐珠单抗的 ORR 分别为 43% 和 50%，索拉非尼的 ORR 分别为 26% 和 30%。根据 IRF RECIST 1，目标病变的 SLD 相对于基线的百分比变化。1 和 HCC mRECIST 显示对阿特珠单抗 + 贝伐单抗治疗的持久反应。安全数据与 atezolizumab 和贝伐珠单抗的已知概况一致，如在总体研究人群中所见。讨论/结论：在基线 BCLC B 期疾病患者中观察到 atezolizumab + 贝伐珠单抗的疗效益处，与意向治疗人群一致。