Immune-mediated adverse events and overall survival with tremelimumab plus durvalumab and durvalumab monotherapy in unresectable HCC: HIMALAYA phase III randomized clinical trial.

Immune checkpoint inhibitorstudies have shown an association between the occurrence of immune-mediated adverse events (imAEs) and improved OS.

免疫检查点抑制剂研究显示，免疫介导的不良事件(imAEs)的发生与总生存期(OS)的改善之间存在关联。

We assessed potential associations between the occurrence of imAEs and OS, and temporal patterns of imAEs, in HIMALAYA.

我们评估了HIMALAYA研究中免疫相关不良事件（imAEs）的发生与总生存（OS）之间的潜在关联，以及imAEs的时间模式。

approach_and_results

OS in participants who did and did not experience imAEs and the frequency and timing of imAEs were assessed for STRIDE and durvalumab in the safety analysis set of HIMALAYA. imAEs occurred in 139/388 (35.8%) and 64/388 (16.5%) participants with STRIDE and durvalumab, respectively; most were low grade.

在HIMALAYA的安全性分析集中，对STRIDE和durvalumab治疗组中发生和未发生imAEs的参与者的总生存（OS）、imAEs的发生频率和时间进行了评估。在使用STRIDE和durvalumab的参与者中，分别有139/388（35.8%）和64/388（16.5%）的参与者出现了imAEs；大多数为低级别。

OS HRs (95% CI) in participants who experienced imAEs versus those who did not were 0.73 (0.56-0.95) for STRIDE and 1.14 (0.82-1.57) for durvalumab.

在经历免疫相关不良事件（imAEs）的参与者中，STRIDE的总生存（OS）风险比（HRs）（95%置信区间[CI]）为0.73（0.56-0.95），而未经历imAEs的参与者为1.14（0.82-1.57）。

The 36-month OS rate (95% CI) for STRIDE was 36.2% (28.1-46.7) and 27.7% (22.4-34.2) in participants who did and did not experience imAEs, respectively.

STRIDE的36个月总生存（OS）率为36.2%（95%置信区间[CI] 28.1-46.7），而在经历和未经历免疫相关不良事件（imAEs）的参与者中，分别为27.7%（95%置信区间[CI] 22.4-34.2）。

The most common imAE category with STRIDE was endocrine events (16.5%).

在STRIDE中，最常见的免疫相关不良事件类别是内分泌事件（占16.5%）。

Most imAEs occurred ≤3 months after treatment initiation.

大多数免疫相关不良事件发生在治疗开始后≤3个月内。

Conclusions

Participants who experienced imAEs with STRIDE had a numerical improvement in OS versus those who did not, which was not observed for durvalumab.

经历STRIDE相关免疫相关不良事件（imAEs）的参与者在总生存（OS）方面有数值上的改善，而未经历imAEs的参与者则没有观察到这种现象，对于durvalumab来说也是如此。

Long-term OS with STRIDE was observed regardless of imAEs.

无论是否出现imAEs，都观察到STRIDE的长期总生存（OS）。

Most imAEs were low grade, manageable, and occurred in the first 3 months after treatment initiation.

大多数免疫相关不良事件（imAEs）为低级别，可管理，并且在治疗开始后的前三个月内发生。

Results continue to support the benefits of STRIDE in a diverse population that reflects unresectable HCC globally.

结果继续支持STRIDE在全球不可切除肝细胞癌（HCC）多样化人群中的益处。