PMID- 36191882
OWN - NLM
STAT- MEDLINE
DCOM- 20230124
LR  - 20230301
IS  - 1556-1380 (Electronic)
IS  - 1556-0864 (Linking)
VI  - 18
IP  - 2
DP  - 2023 Feb
TI  - Adebrelimab (SHR-1316) in Combination With Chemotherapy as Perioperative 
      Treatment in Patients With Resectable Stage II to III NSCLCs: An Open-Label, 
      Multicenter, Phase 1b Trial.
PG  - 194-203
LID - S1556-0864(22)01822-6 [pii]
LID - 10.1016/j.jtho.2022.09.222 [doi]
AB  - INTRODUCTION: This study evaluated adebrelimab (a programmed death-ligand 1 
      antibody) plus nab-paclitaxel and carboplatin as perioperative treatment for 
      resectable NSCLC. METHODS: Eligible patients had resectable stage II to III 
      NSCLCs without driver gene. Patients received neoadjuvant treatment with three 
      cycles of intravenous adebrelimab (20 mg/kg on day 1), nab-paclitaxel (100 
      mg/m(2) 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 wk) adjuvant treatment. The primary 
      end point was major pathologic response (MPR) per blinded independent pathologic 
      review. RESULTS: A total of 37 patients were enrolled and received planned 
      neoadjuvant therapy. There were 34 patients (91.9%) who underwent surgery. As of 
      data cutoff on January 25, 2022, 19 of the 37 patients (51.4%, 95% confidence 
      interval [CI]: 35.9-66.6) achieved MPR per blinded independent pathologic review 
      and 11 patients (29.7%, 95% CI: 17.5-45.8) achieved pathologic complete response. 
      Furthermore, 26 patients (70.3%, 95% CI: 54.2-82.5) had an objective response per 
      Response Evaluation Criteria in Solid Tumors version 1.1. The 12-month event-free 
      survival rate was 77.8% (95% CI: 54.1-90.3). In addition, 29 patients (78.4%) had 
      grade greater than or equal to three treatment-related adverse events (AEs) and 
      nine (24.3%) had treatment-related serious AEs. No treatment-related deaths 
      occurred. Grade greater than or equal to three surgery-related AEs within 30 or 
      90 days after surgery were both reported in five patients (14.7%). CONCLUSIONS: 
      Adebrelimab plus nab-paclitaxel and carboplatin as perioperative therapy led to a 
      substantial proportion of MPR and high resectability, with manageable toxicities. 
      On the basis of the phase 1b results, phase 3 trial was initiated.
CI  - Copyright (c) 2022 International Association for the Study of Lung Cancer. 
      Published by Elsevier Inc. All rights reserved.
FAU - Yan, Wanpu
AU  - Yan W
AD  - Department of Thoracic Oncology I, Beijing Cancer Hospital, Beijing, People's 
      Republic of China.
FAU - Zhong, Wen-Zhao
AU  - Zhong WZ
AD  - Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital & 
      Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.
FAU - Liu, Yan-Hui
AU  - Liu YH
AD  - Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital & 
      Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.
FAU - Chen, Qixun
AU  - Chen Q
AD  - Thoracic Surgery, Zhejiang Cancer Hospital, Hangzhou, People's Republic of China.
FAU - Xing, Wenqun
AU  - Xing W
AD  - Thoracic Surgery Ward, The Affiliated Cancer Hospital of Zhengzhou University & 
      Henan Cancer Hospital, Zhengzhou, People's Republic of China.
FAU - Zhang, Qin
AU  - Zhang Q
AD  - Department of Thoracic Surgery, Jiangsu Cancer Hospital, Nanjing, People's 
      Republic of China.
FAU - Liu, Lunxu
AU  - Liu L
AD  - Department of Thoracic Surgery, West China Hospital of Sichuan University, 
      Chengdu, People's Republic of China.
FAU - Ge, Di
AU  - Ge D
AD  - Thoracic Surgery, Zhongshan Hospital Fudan University, Shanghai, People's 
      Republic of China.
FAU - Chen, Keneng
AU  - Chen K
AD  - Department of Thoracic Oncology I, Beijing Cancer Hospital, Beijing, People's 
      Republic of China.
FAU - Yang, Fan
AU  - Yang F
AD  - Thoracic Surgery, Peking University People's Hospital, Beijing, People's Republic 
      of China.
FAU - Lin, Xiang
AU  - Lin X
AD  - Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, People's Republic of China.
FAU - Song, Li
AU  - Song L
AD  - Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, People's Republic of China.
FAU - Shi, Wei
AU  - Shi W
AD  - Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, People's Republic of China.
FAU - Wu, Yi-Long
AU  - Wu YL
AD  - Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital & 
      Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China. 
      Electronic address: syylwu@live.cn.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20221001
PL  - United States
TA  - J Thorac Oncol
JT  - Journal of thoracic oncology : official publication of the International 
      Association for the Study of Lung Cancer
JID - 101274235
RN  - BG3F62OND5 (Carboplatin)
RN  - P88XT4IS4D (Paclitaxel)
RN  - 0 (Antibodies, Monoclonal)
SB  - IM
MH  - Humans
MH  - Carboplatin
MH  - *Lung Neoplasms/drug therapy/surgery/etiology
MH  - *Carcinoma, Non-Small-Cell Lung/pathology
MH  - Paclitaxel
MH  - Progression-Free Survival
MH  - Neoadjuvant Therapy
MH  - Antibodies, Monoclonal/therapeutic use
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
OTO - NOTNLM
OT  - Adebrelimab
OT  - PD-L1 antibody
OT  - Perioperative therapy
OT  - Resectable NSCLC
EDAT- 2022/10/04 06:00
MHDA- 2023/01/25 06:00
CRDT- 2022/10/03 19:28
PHST- 2022/07/21 00:00 [received]
PHST- 2022/09/15 00:00 [revised]
PHST- 2022/09/20 00:00 [accepted]
PHST- 2022/10/04 06:00 [pubmed]
PHST- 2023/01/25 06:00 [medline]
PHST- 2022/10/03 19:28 [entrez]
AID - S1556-0864(22)01822-6 [pii]
AID - 10.1016/j.jtho.2022.09.222 [doi]
PST - ppublish
SO  - J Thorac Oncol. 2023 Feb;18(2):194-203. doi: 10.1016/j.jtho.2022.09.222. Epub 
      2022 Oct 1.