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
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 pacl...
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China Anti-Cancer Association
2021-08-01
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doaj-89f482a744bd43afbb9a85d6f45c28a52021-08-10T05:03:48ZengChina Anti-Cancer AssociationCancer Biology & Medicine2095-39412021-08-0118381682410.20892/j.issn.2095-3941.2020.0212Equivalent efficacy study of QL1101 and bevacizumab on untreated advanced non-squamous non-small cell lung cancer patients: a phase 3 randomized, double-blind clinical trialTianqing Chu0Jun Lu1Minghong Bi2Helong Zhang3Wu Zhuang4Yan Yu5Jianhua Shi6Zhendong Chen7Xiaochun Zhang8Qisen Guo9Quan Liu10Huijuan Wu11Jian Fang12Yi Hu13Xiuwen Wang14Cuicui Han15Kai Li16Baohui Han17Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, ChinaDepartment of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, ChinaDepartment of Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu 233004, ChinaDepartment of Oncology, Tangdu Hospital, Air Force Medical University of PLA, Xi’an 710038, ChinaDepartment of Medical Thoracic Oncology, Fujian Cancer Hospital, Fujian Medical University Cancer Hospital, Fuzhou 350014, ChinaDepartment of Oncology, Harbin Medical University Cancer Hospital, Harbin 150081, ChinaDepartment of Oncology, Linyi Cancer Hospital, Linyi 276000, ChinaDepartment of Oncology, The Second Hospital of Anhui Medical University, Hefei 230601, ChinaDepartment of Oncology, The Affiliated Hospital of Qingdao University, Qingdao 266071, ChinaDepartment of Internal Medicine, Shandong Cancer Hospital Affiliated to Shandong University, Jinan 250117, ChinaDepartment of Oncology, Affiliated Hospital of Jiang Nan University, Wuxi 214122, ChinaDepartment of Internal Medicine, Henan Province Tumor Hospital, Zhengzhou University, Zhengzhou 450008, ChinaDepartment of Thoracic Oncology II, Peking University Cancer Hospital and Institute, Beijing 100142, ChinaDepartment of Oncology, Chinese PLA General Hospital, Beijing 100039, ChinaDepartment of Oncology, Qilu Hospital of Shandong University, Jinan 250012, ChinaDepartment of Clinical Research Centre, Qilu Pharmaceutical Co., Ltd, Jinan 250101, ChinaDepartment 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, ChinaDepartment of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, ChinaObjective: 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.http://www.cancerbiomed.org/index.php/cocr/article/view/1829biosimilarbevacizumabequivalencenon-squamous nsclcclinical efficacy |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Tianqing Chu Jun Lu Minghong Bi Helong Zhang Wu Zhuang Yan Yu Jianhua Shi Zhendong Chen Xiaochun Zhang Qisen Guo Quan Liu Huijuan Wu Jian Fang Yi Hu Xiuwen Wang Cuicui Han Kai Li Baohui Han |
spellingShingle |
Tianqing Chu Jun Lu Minghong Bi Helong Zhang Wu Zhuang Yan Yu Jianhua Shi Zhendong Chen Xiaochun Zhang Qisen Guo Quan Liu Huijuan Wu Jian Fang Yi Hu Xiuwen Wang Cuicui Han Kai Li Baohui Han 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 Cancer Biology & Medicine biosimilar bevacizumab equivalence non-squamous nsclc clinical efficacy |
author_facet |
Tianqing Chu Jun Lu Minghong Bi Helong Zhang Wu Zhuang Yan Yu Jianhua Shi Zhendong Chen Xiaochun Zhang Qisen Guo Quan Liu Huijuan Wu Jian Fang Yi Hu Xiuwen Wang Cuicui Han Kai Li Baohui Han |
author_sort |
Tianqing Chu |
title |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publisher |
China Anti-Cancer Association |
series |
Cancer Biology & Medicine |
issn |
2095-3941 |
publishDate |
2021-08-01 |
description |
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. |
topic |
biosimilar bevacizumab equivalence non-squamous nsclc clinical efficacy |
url |
http://www.cancerbiomed.org/index.php/cocr/article/view/1829 |
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