PMID- 33710815
OWN - NLM
STAT- Publisher
LR  - 20240222
IS  - 2095-3941 (Print)
IS  - 2095-3941 (Linking)
VI  - 18
IP  - 3
DP  - 2021 Mar 12
TI  - Equivalent efficacy study of QL1101 and bevacizumab on untreated advanced 
      non-squamous non-small cell lung cancer patients: a phase 3 randomized, 
      double-blind clinical trial.
PG  - 816-24
LID - j.issn.2095-3941.2020.0212 [pii]
LID - 10.20892/j.issn.2095-3941.2020.0212 [doi]
AB  - OBJECTIVE: This phase 3 study aimed to test equivalence in efficacy and safety 
      for QL1101, a bevacizumab analogue in Chinese patients with untreated locally 
      advanced non-squamous non-small cell lung cancer (NSCLC). METHODS: Eligible 
      patients were randomly assigned 1:1 to receive carboplatin and paclitaxel in 
      combination with either QL1101 or bevacizumab, 15 mg/kg every 3-week for 6 
      cycles. This was followed by maintenance treatment with single agent QL1101 every 
      3-week. The primary end-point was objective response rate (ORR), with secondary 
      end-points being progression-free survival (PFS), overall survival (OS), disease 
      control rate (DCR), and adverse events (AEs). RESULTS: Of 675 patients, 535 
      eligible patients were randomized to the QL1101 group (n = 269) and bevacizumab 
      group (n = 266). ORRs were 52.8% and 56.8%, respectively, for the QL1101 and 
      bevacizumab groups, with an ORR hazard ratio 0.93 (95% confidence interval: 
      0.8-0131.1). The PFS, OS, DCR, and AEs were comparable between the 2 groups, 
      which remained the same after stratification according to epidermal growth factor 
      receptor mutation or smoking history. CONCLUSIONS: QL1101 showed similar efficacy 
      and safety profiles as compared to bevacizumab among Chinese patients with 
      untreated locally advanced non-squamous NSCLC.
CI  - Copyright (c) 2021 Cancer Biology & Medicine.
FAU - Chu, Tianqing
AU  - Chu T
AD  - Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong 
      University, Shanghai 200030, China.
FAU - Lu, Jun
AU  - Lu J
AD  - Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong 
      University, Shanghai 200030, China.
FAU - Bi, Minghong
AU  - Bi M
AD  - Department of Oncology, The First Affiliated Hospital of Bengbu Medical College, 
      Bengbu 233004, China.
FAU - Zhang, Helong
AU  - Zhang H
AD  - Department of Oncology, Tangdu Hospital, Air Force Medical University of PLA, 
      Xi'an 710038, China.
FAU - Zhuang, Wu
AU  - Zhuang W
AD  - Department of Medical Thoracic Oncology, Fujian Cancer Hospital, Fujian Medical 
      University Cancer Hospital, Fuzhou 350014, China.
FAU - Yu, Yan
AU  - Yu Y
AD  - Department of Oncology, Harbin Medical University Cancer Hospital, Harbin 150081, 
      China.
FAU - Shi, Jianhua
AU  - Shi J
AD  - Department of Oncology, Linyi Cancer Hospital, Linyi 276000, China.
FAU - Chen, Zhendong
AU  - Chen Z
AD  - Department of Oncology, The Second Hospital of Anhui Medical University, Hefei 
      230601, China.
FAU - Zhang, Xiaochun
AU  - Zhang X
AD  - Department of Oncology, The Affiliated Hospital of Qingdao University, Qingdao 
      266071, China.
FAU - Guo, Qisen
AU  - Guo Q
AD  - Department of Internal Medicine, Shandong Cancer Hospital Affiliated to Shandong 
      University, Jinan 250117, China.
FAU - Liu, Quan
AU  - Liu Q
AD  - Department of Oncology, Affiliated Hospital of Jiang Nan University, Wuxi 214122, 
      China.
FAU - Wu, Huijuan
AU  - Wu H
AD  - Department of Internal Medicine, Henan Province Tumor Hospital, Zhengzhou 
      University, Zhengzhou 450008, China.
FAU - Fang, Jian
AU  - Fang J
AD  - Department of Thoracic Oncology II, Peking University Cancer Hospital and 
      Institute, Beijing 100142, China.
FAU - Hu, Yi
AU  - Hu Y
AD  - Department of Oncology, Chinese PLA General Hospital, Beijing 100039, China.
FAU - Wang, Xiuwen
AU  - Wang X
AD  - Department of Oncology, Qilu Hospital of Shandong University, Jinan 250012, 
      China.
FAU - Han, Cuicui
AU  - Han C
AD  - Department of Clinical Research Centre, Qilu Pharmaceutical Co., Ltd, Jinan 
      250101, China.
FAU - Li, Kai
AU  - Li K
AUID- ORCID: 0000-0002-6895-0024
AD  - Department of Thoracic Oncology, Tianjin Medical University Cancer Institute and 
      Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer 
      Prevention and Therapy, Tianjin, Tianjin's Clinical Research Center for Cancer, 
      Tianjin 300060, China.
FAU - Han, Baohui
AU  - Han B
AUID- ORCID: 0000-0002-3950-3030
AD  - Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong 
      University, Shanghai 200030, China.
LA  - eng
PT  - Journal Article
DEP - 20210312
PL  - China
TA  - Cancer Biol Med
JT  - Cancer biology & medicine
JID - 101588850
SB  - IM
PMC - PMC8330542
OTO - NOTNLM
OT  - Biosimilar
OT  - bevacizumab
OT  - clinical efficacy
OT  - equivalence
OT  - non-squamous NSCLC
COIS- This study was supported by Qilu Pharmaceutical Group Co, Ltd. No other potential 
      conflicts of interests are disclosed.
EDAT- 2021/03/13 06:00
MHDA- 2021/03/13 06:00
PMCR- 2021/08/15
CRDT- 2021/03/12 13:05
PHST- 2021/03/12 13:05 [entrez]
PHST- 2021/03/13 06:00 [pubmed]
PHST- 2021/03/13 06:00 [medline]
PHST- 2021/08/15 00:00 [pmc-release]
AID - j.issn.2095-3941.2020.0212 [pii]
AID - 10.20892/j.issn.2095-3941.2020.0212 [doi]
PST - aheadofprint
SO  - Cancer Biol Med. 2021 Mar 12;18(3):816-24. doi: 
      10.20892/j.issn.2095-3941.2020.0212.