PMID- 32010577
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240328
IS  - 2218-6751 (Print)
IS  - 2226-4477 (Electronic)
IS  - 2218-6751 (Linking)
VI  - 8
IP  - 6
DP  - 2019 Dec
TI  - Biosimilar candidate IBI305 plus paclitaxel/carboplatin for the treatment of 
      non-squamous non-small cell lung cancer.
PG  - 989-999
LID - 10.21037/tlcr.2019.12.23 [doi]
AB  - BACKGROUND: Bevacizumab is a monoclonal antibody (mAb) against vascular 
      endothelial growth factor (VEGF) and used for treatments of various cancers. Due 
      to the high costs of bevacizumab treatments, a biosimilar provides an affordable 
      alternative therapy for cancer patients. METHODS: In this randomized, 
      double-blind, multicenter, phase 3 study, locally advanced, metastatic or 
      recurrent non-squamous non-small cell lung cancer (NSCLC) patients with wild-type 
      epidermal growth factor receptor were enrolled and randomized (1:1) into IBI305 
      or bevacizumab groups. Patients received 6 cycles of paclitaxel/carboplatin plus 
      IBI305 or bevacizumab 15 mg/kg intravenously followed by IBI305 or bevacizumab 
      7.5 mg/kg maintenance until disease progression, unacceptable toxicity or death. 
      The primary endpoint was confirmed objective response rate (ORR) by an 
      independent radiological review committee (IRRC) and secondary endpoints included 
      disease control rate (DCR), progression-free survival (PFS), duration of response 
      (DOR), overall survival (OS) and safety. RESULTS: A total of 450 NSCLC patients 
      were enrolled (224 in IBI305 group and 226 in bevacizumab group). ORRs were 44.3% 
      for IBI305 and 46.4% for bevacizumab, and the ORR ratio was 0.95 (90% CI: 0.803 
      to 1.135), within the predefined equivalence margin of 0.75 to 1.33. No 
      significant difference in PFS (7.64 vs. 7.77 m, P=0.9987) was observed between 
      the 2 groups. Serious adverse events (AEs) occurred in 33.5% (75/224) of patients 
      in the IBI305 group and 37.6% (85/226) in the bevacizumab group. AEs >/= grade 3 
      were similar in the IBI305 and bevacizumab groups [84.4% (189/224) vs. 89.8% 
      (203/226), P=0.085]. CONCLUSIONS: IBI305 is similar to bevacizumab in terms of 
      efficacy and safety. TRIAL REGISTRATION: Clinicaltrials.org Identifier: 
      NCT02954172. Registered on 3 November 2016. Https://clinicaltrials.gov/.
CI  - 2019 Translational Lung Cancer Research. All rights reserved.
FAU - Yang, Yunpeng
AU  - Yang Y
AD  - Department of Medical Oncology, State Key Laboratory of Oncology in South China, 
      Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University 
      Cancer Center, Guangzhou 510000, China.
FAU - Wu, Bin
AU  - Wu B
AD  - Department of Respiratory Medicine, Affiliated Hospital of Guangdong Medical 
      University, Zhanjiang 524002, China.
FAU - Huang, Linian
AU  - Huang L
AD  - Department of Respiratory Medicine, The First Affiliated Hospital of Bengbu 
      Medical College, Bangbu 233000, China.
FAU - Shi, Meiqi
AU  - Shi M
AD  - Department of Oncology, Jiangsu Cancer Hospital, Nanjing 210009, China.
FAU - Liu, Yunpeng
AU  - Liu Y
AD  - Department of Oncology, The First Hospital of China Medical University, Shenyang 
      110001, China.
FAU - Zhao, Yanqiu
AU  - Zhao Y
AD  - Department of Respiratory Medicine, Henan Cancer Hospital, Zhengzhou 450003, 
      China.
FAU - Wang, Lijun
AU  - Wang L
AD  - Department of Tumor radiotherapy, The Second Affiliated Hospital of Xingtai 
      Medical College, Xingtai 054000, China.
FAU - Lu, Shun
AU  - Lu S
AD  - Department of Oncology, Shanghai Chest Hospital, Shanghai 200030, China.
FAU - Chen, Gongyan
AU  - Chen G
AD  - Department of Oncology, Harbin Medical University Cancer Hospital, Harbin 150081, 
      China.
FAU - Li, Baolan
AU  - Li B
AD  - General Department, Beijing Chest Hospital, Capital Medical University, Beijing 
      101149, China.
FAU - Xie, Conghua
AU  - Xie C
AD  - Department of Oncology, Zhongnan Hospital of Wuhan University, Wuhan 430071, 
      China.
FAU - Fang, Jian
AU  - Fang J
AD  - Department of Oncology, Peking University Cancer Hospital, Beijing 100142, China.
FAU - Yang, Nong
AU  - Yang N
AD  - Department of Pulmonary Gastroenterology, Hunan Cancer Hospital, Changsha 410006, 
      China.
FAU - Zhang, Yiping
AU  - Zhang Y
AD  - Department of Oncology, Zhejiang Cancer Hospital, Hangzhou 310022, China.
FAU - Cui, Jiuwei
AU  - Cui J
AD  - Department of Oncology, The First Hospital of Jilin University, Changchun 130000, 
      China.
FAU - Song, Yong
AU  - Song Y
AD  - Department of Respiratory Medicine, General Hospital of Eastern Theater Command, 
      Nanjing 210002, China.
FAU - Zhang, Cuiying
AU  - Zhang C
AD  - Department of Oncology, Inner Mongolia People's Hospital, Hohhot 010017, China.
FAU - Mei, Xiaodong
AU  - Mei X
AD  - Department of Respiratory Medicine, An Hui Provincial Hospital, Hefei 230000, 
      China.
FAU - Cao, Bangwei
AU  - Cao B
AD  - Department of Oncology, Peking Friendship Hospital, Capital Medical University, 
      Beijing 100050, China.
FAU - Yang, Lan
AU  - Yang L
AD  - Department of Respiratory Medicine, The First Affiliated Hospital of Xi'an 
      Jiaotong University, Xi'an 710061, China.
FAU - Cheng, Ying
AU  - Cheng Y
AD  - Department of Oncology, Jilin Cancer Hospital, Changchun 130000, China.
FAU - Ying, Kejing
AU  - Ying K
AD  - Department of Respiratory Medicine, Sir Run Shaw Hospital of Zhejiang University 
      School of Medicine, Hangzhou 310016, China.
FAU - Sun, Tao
AU  - Sun T
AD  - Department of Internal Medicine, Liaoning Cancer Hospital & Institute, Shenyang 
      110046, China.
FAU - Ren, Biyong
AU  - Ren B
AD  - Department of Respiratory Medicine, Chongqing three Gorges Central Hospital, 
      Chongqing 404000, China.
FAU - Yu, Qitao
AU  - Yu Q
AD  - Department of Oncology, The Cancer Hospital of Guangxi Zhuang Autonomous Region, 
      Nanning 530000, China.
FAU - Liao, Zijun
AU  - Liao Z
AD  - Department of Internal Medicine, Shaanxi Provincial Tumor Hospital, Xi'an 710061, 
      China.
FAU - Pei, Zhidong
AU  - Pei Z
AD  - Department of Oncology, Luoyang Central Hospital Affiliated To Zhengzhou 
      University, Luoyang 471009, China.
FAU - Wang, Mengzhao
AU  - Wang M
AD  - Department of Respiratory Medicine, Peking Union Medical College Hospital, 
      Beijing 100005, China.
FAU - Zhou, Jianying
AU  - Zhou J
AD  - Department of Respiratory Medicine, The First Affiliated Hospital Zhejiang 
      University, Hangzhou 310003, China.
FAU - Yu, Shiying
AU  - Yu S
AD  - Department of Oncology, Tongji Hospital Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan 430000, China.
FAU - Feng, Guosheng
AU  - Feng G
AD  - Department of Chemotherapy, The People's Hospital of Guangxi Zhuang Autonomous 
      Region, Nanning 530000, China.
FAU - Wan, Huiping
AU  - Wan H
AD  - Department of Oncology, Jiangxi People's Hospital, Nanchang 330000, China.
FAU - Wang, Huaqing
AU  - Wang H
AD  - Department of Oncology, Tianjin People's Hospital, Tianjin 300121, China.
FAU - Gao, Shegan
AU  - Gao S
AD  - Department of Oncology, First Affiliated Hospital of Henan University of Science 
      and Technology, Luoyang 471000, China.
FAU - Wang, Jinliang
AU  - Wang J
AD  - Department of Oncology, General Hospital of PLA, Beijing 100853, China.
FAU - An, Guangyu
AU  - An G
AD  - Department of Oncology, Beijing Chao-Yang Hospital, Beijing 100020, China.
FAU - Geng, Yi
AU  - Geng Y
AD  - Department of Oncology, Baoji Central Hospital, Baoji 721008, China.
FAU - Ji, Yanxia
AU  - Ji Y
AD  - Department of Oncology, Handan Central Hospital, Handan 056001, China.
FAU - Yuan, Ying
AU  - Yuan Y
AD  - Department of Oncology, The Second Affiliated Hospital Zhejiang University, 
      Hangzhou 310009, China.
FAU - Ma, Shenglin
AU  - Ma S
AD  - Department of Oncology, Hangzhou First People's Hospital, Hangzhou 310002, China.
FAU - Jia, Zhongyao
AU  - Jia Z
AD  - Department of Oncology, Linyi People's Hospital, Linyi 276003, China.
FAU - Hu, Mu
AU  - Hu M
AD  - Department of Chest Surgery, Xuanwu Hospital Capital Medical University, Beijing 
      100053, China.
FAU - Zhou, Hui
AU  - Zhou H
AD  - Innovent Biologics, Inc., Suzhou 215123, China.
FAU - Yu, Jie
AU  - Yu J
AD  - Innovent Biologics, Inc., Suzhou 215123, China.
FAU - Sun, Xing
AU  - Sun X
AD  - Innovent Biologics, Inc., Suzhou 215123, China.
FAU - Zhang, Li
AU  - Zhang L
AD  - Department of Medical Oncology, State Key Laboratory of Oncology in South China, 
      Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University 
      Cancer Center, Guangzhou 510000, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT02954172
PT  - Journal Article
PL  - China
TA  - Transl Lung Cancer Res
JT  - Translational lung cancer research
JID - 101646875
PMC - PMC6976344
OTO - NOTNLM
OT  - Bevacizumab
OT  - IBI305
OT  - biosimilar
OT  - non-small cell lung cancer (NSCLC)
OT  - vascular endothelial growth factor (VEGF)
COIS- Conflicts of Interest: L Zhang received research grants from Eli Lily and Pfizer. 
      H Zhou, J Yu and X Sun are staff of Innovent Biologics, Inc. The other authors 
      have no conflicts of interest to declare.
EDAT- 2020/02/06 06:00
MHDA- 2020/02/06 06:01
PMCR- 2019/12/01
CRDT- 2020/02/04 06:00
PHST- 2020/02/04 06:00 [entrez]
PHST- 2020/02/06 06:00 [pubmed]
PHST- 2020/02/06 06:01 [medline]
PHST- 2019/12/01 00:00 [pmc-release]
AID - tlcr-08-06-989 [pii]
AID - 10.21037/tlcr.2019.12.23 [doi]
PST - ppublish
SO  - Transl Lung Cancer Res. 2019 Dec;8(6):989-999. doi: 10.21037/tlcr.2019.12.23.