IMbrella A 是一项 III 期扩展研究，允许从罗氏/基因泰克赞助的 atezolizumab 试验进行延期，其中包括 IMpower133，这是一线 atezolizumab 或安慰剂加卡铂/依托泊苷治疗广泛期小细胞肺癌的 I/III 期试验。我们报告了 IMpower133 探索性分析的结果，其中包含转入 IMbrella A 的患者的延长事件发生时间数据。如果 IMpower133 患者继续在IMpower133 关闭或在 atezolizumab 停药后正在进行生存随访。评估总体生存率和安全性； IMbrella A 中仅收集了严重不良事件和特别关注的 AE。26 名符合条件的患者中，有 18 名转入 IMbrella A。在临床截止时（2023 年 3 月 16 日），atezolizumab 加卡铂/依托泊苷组 (IMpower133) 的中位随访时间IMbrella A) 为 59.4 个月。三年、四年和五年总体生存率 (95% CI) 估计值分别为 16% (11%-21%)、13% (8%-18%) 和 12% (7%-17%) ， 分别。在 IMbrella A 中，三名患者 (16.7%) 发生了严重不良事件，并报告了一项特别令人关注的不良事件（二级甲状腺功能减退症）。这项对先前纳入 IMpower133 的 IMbrella A 患者的长期分析提供了第一份报告接受一线癌症免疫治疗和化疗的广泛期小细胞肺癌患者的五年总体生存结果。尽管受到患者数量较少且缺乏 IMpower133 对照组长期数据的限制，但对接受阿特珠单抗加卡铂/依托泊苷治疗的患者进行的探索性总体生存分析与单独化疗的历史数据相比，效果良好。 NCT03148418.版权所有 © 2024。由 Elsevier B.V. 出版

IMbrella A is a Phase III extension study that allowed rollover from Roche/Genentech-sponsored atezolizumab trials, including IMpower133, a Phase I/III trial of first-line atezolizumab or placebo plus carboplatin/etoposide in extensive-stage small cell lung cancer. We report outcomes from an exploratory analysis of IMpower133 with extended time-to-event data for patients who rolled over to IMbrella A.IMpower133 patients could roll over to IMbrella A to receive atezolizumab 1200 mg intravenously every three weeks if they continued to receive atezolizumab at IMpower133 closure or were in survival follow-up after atezolizumab discontinuation. Overall survival and safety were assessed; only serious adverse events and AEs of special interest were collected in IMbrella A.Eighteen of 26 eligible patients rolled over to IMbrella A. At clinical cutoff (March 16, 2023), median follow-up in the atezolizumab plus carboplatin/etoposide arm (IMpower133 and IMbrella A) was 59.4 months. The three-, four-, and five-year overall survival (95 % CI) estimates were 16 % (11 %-21 %), 13 % (8 %-18 %), and 12 % (7 %-17 %), respectively. In IMbrella A, serious adverse events occurred in three patients (16.7 %), and one adverse event of special interest was reported (grade two hypothyroidism).This long-term analysis of patients from IMbrella A previously enrolled in IMpower133 provides the first report of five-year overall survival outcomes in patients with extensive-stage small cell lung cancer treated with first-line cancer immunotherapy and chemotherapy. While limited by small patient numbers and lack of long-term data for the IMpower133 control arm, exploratory overall survival analyses in patients treated with atezolizumab plus carboplatin/etoposide compared favorably with historical data with chemotherapy alone. NCT03148418.Copyright © 2024. Published by Elsevier B.V.