Five-year survival in patients with extensive-stage small cell lung cancer treated with atezolizumab in the Phase III IMpower133 study and the Phase III IMbrella A extension study

IF 4.5 2区 医学 Q1 ONCOLOGY Lung Cancer Pub Date : 2024-08-10 DOI:10.1016/j.lungcan.2024.107924
Martin Reck , Rafal Dziadziuszko , Shunichi Sugawara , Steven Kao , Maximilian Hochmair , Florian Huemer , Gilberto de Castro Jr , Libor Havel , Reyes Bernabé Caro , György Losonczy , Jong-Seok Lee , Dariusz M. Kowalski , Zoran Andric , Raffaele Califano , Andrea Veatch , Gregory Gerstner , Marta Batus , Stefanie Morris , Monika Kaul , Vaikunth Cuchelkar , Stephen V. Liu
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Abstract

Objectives

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.

Materials and Methods

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.

Results

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).

Conclusion

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.

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III 期 IMpower133 研究和 III 期 IMbrella A 扩展研究中接受阿特珠单抗治疗的广泛期小细胞肺癌患者的五年生存率
目的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(包括IMpower133)转入IMbrella A,IMpower133是针对广泛期小细胞肺癌的一线atezolizumab或安慰剂加卡铂/依托泊苷的I/III期试验。材料与方法IMpower133患者如果在IMpower133结束时继续接受阿特珠单抗治疗,或在阿特珠单抗停药后处于生存随访阶段,则可以转入IMbrella A,每三周静脉注射1200毫克阿特珠单抗。在临床截止日期(2023 年 3 月 16 日),atezolizumab 加卡铂/依托泊苷治疗组(IMpower133 和 IMbrella A)的中位随访时间为 59.4 个月。三年、四年和五年总生存期(95 % CI)估计值分别为16%(11%-21%)、13%(8%-18%)和12%(7%-17%)。在 IMbrella A 中,有三名患者(16.7%)发生了严重不良事件,并报告了一起特别值得关注的不良事件(二级甲状腺功能减退)。虽然IMpower133对照组的患者人数较少且缺乏长期数据,但阿特珠单抗加卡铂/依托泊苷治疗患者的探索性总生存期分析与单独化疗的历史数据相比效果良好。
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来源期刊
Lung Cancer
Lung Cancer 医学-呼吸系统
CiteScore
9.40
自引率
3.80%
发文量
407
审稿时长
25 days
期刊介绍: Lung Cancer is an international publication covering the clinical, translational and basic science of malignancies of the lung and chest region.Original research articles, early reports, review articles, editorials and correspondence covering the prevention, epidemiology and etiology, basic biology, pathology, clinical assessment, surgery, chemotherapy, radiotherapy, combined treatment modalities, other treatment modalities and outcomes of lung cancer are welcome.
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