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Adebrelimab (SHR-1316) in combination with chemotherapy as perioperative treatment in patients with resectable stage II-III NSCLC: an open-label, multicenter, phase 1b trial

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机构: [1]Department of Thoracic Oncology I, Beijing Cancer Hospital, Beijing, China. [2]Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China. [3]Thoracic Surgery, Zhejiang Cancer Hospital, Hangzhou, China. [4]Thoracic Surgery Ward, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China. [5]Department of Thoracic Surgery, Jiangsu Cancer Hospital, Nanjing, China. [6]Department of Thoracic Surgery, West China Hospital of Sichuan University, Chengdu, China. [7]Thoracic Surgery, Zhongshan Hospital Fudan University, Shanghai, China. [8]Thoracic Surgery, Peking University People's Hospital, Beijing, China. [9]Jiangsu Hengrui Pharmaceuticals Co, Ltd, Shanghai, China.
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关键词: Adebrelimab NSCLC perioperative therapy

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This study evaluated adebrelimab (a PD-L1 antibody) plus nab-paclitaxel and carboplatin as perioperative treatment for resectable NSCLC.Eligible patients had resectable stage II-III NSCLCs without driver gene. Patients received neoadjuvant treatment with 3 cycles of intravenous adebrelimab (20 mg/kg on day 1), nab-paclitaxel (100 mg/m2 on days 1, 8, and 15), and carboplatin (area under the curve 5 mg/mL per min on day 1), of each 21-day cycle before surgical resection, and followed by 16 cycles of adebrelimab (20 mg/kg on day 1 in 3 weeks) adjuvant treatment. The primary endpoint was major pathological response (MPR) per blinded independent pathological review (BIPR).A total of 37 patients were enrolled and received planned neoadjuvant therapy. Thirty-four (91.9%) patients underwent surgery. As of data cutoff on Jan 25, 2022, 19 (51.4%, 95% CI 35.9-66.6) of the 37 patients achieved MPR per BIPR and 11 (29.7%, 95% CI 17.5-45.8) patients achieved pathological complete response. Twenty-six (70.3%, 95% CI 54.2-82.5) patients had an objective response per RECIST v1.1. The 12-month event-free survival (EFS) rate was 77.8% (95% CI 54.1-90.3). Twenty-nine (78.4%) patients had grade ≥3 treatment-related adverse events (AEs) and nine (24.3%) had treatment-related serious AEs. No treatment-related deaths occurred. Grade ≥3 surgery-related AEs within 30 or 90 days after surgery were both reported in 5 (14.7%) patients.Adebrelimab plus nab-paclitaxel and carboplatin as perioperative therapy led to a substantial proportion of MPR and high resectability, with manageable toxicities. Based on the phase 1b results, phase 3 trial was initiated.Copyright © 2022 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.

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大类 | 1 区 医学
小类 | 1 区 肿瘤学 1 区 呼吸系统
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大类 | 1 区 医学
小类 | 1 区 肿瘤学 1 区 呼吸系统
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Q1 ONCOLOGY Q1 RESPIRATORY SYSTEM
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Q1 ONCOLOGY Q1 RESPIRATORY SYSTEM

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第一作者机构: [1]Department of Thoracic Oncology I, Beijing Cancer Hospital, Beijing, China.
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通讯机构: [2]Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China. [*1]Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital & Guangdong Academy of Medical Sciences, No. 106, Zhongshan Second Road, Guangzhou 510080, China
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