Updated data from IMbrave050: Adjuvant atezolizumab plus bevacizumab for high-risk hepatocellular carcinoma.

The RFS hazard ratio(HR) for atezolizumab plus bevacizumab vs. active surveillance was 0.72 (adjusted 95% CI 0.53-0.98; p = 0.012), and overall survival(OS) data were immature.

阿替利珠单抗联合贝伐珠单抗与主动监测相比，无复发生存（RFS）的风险比（HR）为0.72（调整后的95%置信区间0.53-0.98；p = 0.012），而总生存（OS）数据尚未成熟。

Here, we report an updated post hoc analysis of RFS and the second IA of OS, along with additional data.

在这里，我们报告了无复发生存期（RFS）的更新后分析结果以及总生存（OS）的第二次意向性分析，并提供了额外的数据。

Methods

IMbrave050 enrolled patients with HCC who had high recurrence risk following curative-intent resection or ablation.

IMbrave050研究招募了接受治愈性切除或消融治疗后高复发风险的肝细胞癌（HCC）患者。

Patients were randomized 1:1 to receive atezolizumab 1,200 mg plus bevacizumab 15 mg/kg intravenously every 3 weeks (17 cycles) or active surveillance for 1 year; patients were eligible to cross over to atezolizumab plus bevacizumab following IRF-assessed recurrence.

患者按1:1的比例随机接受每3周静脉注射阿替利珠单抗1200毫克加贝伐单抗15毫克/公斤共17个周期，或接受为期一年的主动监测；在IRF评估复发后，患者有资格转为接受阿替利珠单抗加贝伐单抗治疗。

Stratification factors included geographic region and a composite factor comprising the number of high-risk features, curative procedure, and use of optional adjuvant transarterial chemoembolization (one cycle) post-resection.

分层因素包括地理区域和一个综合因素，该因素包括高风险特征的数量、治愈性手术以及术后可选的辅助性经动脉化疗栓塞（TACE）（一个周期）的使用。

Secondary endpoints included OS and safety.

次要终点包括总生存和安全性。

Results

In the updated analysis, RFS HR was 0.90 (95% CI 0.72-1.12).

在更新的分析中，无复发生存期的危险比为0.90（95%置信区间0.72-1.12）。

At the second IA, OS data remained immature (HR 1.26; 95% CI 0.85-1.87).

在第二次中期分析中，总生存数据仍不成熟（风险比1.26；95%置信区间0.85-1.87）。

RFS and OS results were consistent across clinically relevant subgroups.

无复发生存（RFS）和总生存（OS）结果在临床相关亚组中保持一致。

Updated safety data were consistent with the primary analysis.

更新后的安全性数据与初步分析结果一致。

Conclusions

In this updated analysis, the initial RFS benefit seen with atezolizumab plus bevacizumab vs. active surveillance was not sustained and OS data remained immature.

在这次更新的分析中，阿替利珠单抗联合贝伐珠单抗与主动监测相比，最初观察到的无复发生存（RFS）优势并未持续，而总生存（OS）数据仍然不成熟。

The safety profile of atezolizumab plus bevacizumab remained manageable and consistent with that of each agent and the underlying disease.

Atezolizumab联合Bevacizumab的安全性特征保持可控，并与每种药物及基础疾病的特征一致。

Overall, the benefit-risk profile does not support atezolizumab plus bevacizumab as adjuvant therapy.

总体而言，效益-风险特征不支持将Atezolizumab联合Bevacizumab作为辅助治疗。

impact_and_implications

Based on results from the IMbrave150 trial, atezolizumab in combination with bevacizumab is the standard-of-care first-line treatment for unresectable hepatocellular carcinoma (HCC), prompting interest in investigating the combination in earlier treatment settings.

基于IMbrave150试验的结果，阿替利珠单抗联合贝伐珠单抗成为不可切除性肝细胞癌（HCC）的一线标准治疗，引发了在更早治疗阶段研究这种联合疗法的兴趣。

IMbrave050 was the first immunotherapy study to report data in the adjuvant setting for HCC, where an early recurrence-free survival benefit was observed at the pre-specified interim analysis but not maintained with longer follow-up; overall survivaldata remained immature.

IMbrave050是首个在HCC辅助治疗环境中报告数据的免疫治疗研究，在预先设定的中期分析中观察到早期无复发生存期获益，但在更长的随访中未能维持；总生存数据仍然不成熟。

The updated results of IMbrave050 do not support the use of atezolizumab plus bevacizumab in the adjuvant setting.

IMbrave050的最新结果并不支持在辅助治疗中使用阿替利珠单抗联合贝伐珠单抗。

However, subgroup analyses suggest a potential benefit in select patients, warranting further prospective evaluation.

然而，亚组分析表明，在特定患者中可能存在潜在益处，这需要进一步的前瞻性评估。

Effective perioperative or adjuvant treatment remains a major unmet need for patients with HCC given the high rate of early post-operative relapse.

鉴于早期术后复发率高，对于肝细胞癌（HCC）患者来说，有效的围手术期或辅助治疗仍然是一个主要的未满足需求。

clinical_trial_number

NCT04102098.

NCT04102098。