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Original Article | Open Access

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

Tianqing Chu1,*, Jun Lu1,*, Minghong Bi2, Helong Zhang3, Wu Zhuang4, Yan Yu5, Jianhua Shi6, Zhendong Chen7, Xiaochun Zhang8, Qisen Guo9, Quan Liu10, Huijuan Wu11, Jian Fang12, Yi Hu13, Xiuwen Wang14, Cuicui Han15, Kai Li16 ( ), Baohui Han1 ( )
Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, China
Department of Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu 233004, China
Department of Oncology, Tangdu Hospital, Air Force Medical University of PLA, Xi’an 710038, China
Department of Medical Thoracic Oncology, Fujian Cancer Hospital, Fujian Medical University Cancer Hospital, Fuzhou 350014, China
Department of Oncology, Harbin Medical University Cancer Hospital, Harbin 150081, China
Department of Oncology, Linyi Cancer Hospital, Linyi 276000, China
Department of Oncology, The Second Hospital of Anhui Medical University, Hefei 230601, China
Department of Oncology, The Affiliated Hospital of Qingdao University, Qingdao 266071, China
Department of Internal Medicine, Shandong Cancer Hospital Affiliated to Shandong University, Jinan 250117, China
Department of Oncology, Affiliated Hospital of Jiang Nan University, Wuxi 214122, China
Department of Internal Medicine, Henan Province Tumor Hospital, Zhengzhou University, Zhengzhou 450008, China
Department of Thoracic Oncology Ⅱ, Peking University Cancer Hospital and Institute, Beijing 100142, China
Department of Oncology, Chinese PLA General Hospital, Beijing 100039, China
Department of Oncology, Qilu Hospital of Shandong University, Jinan 250012, China
Department of Clinical Research Centre, Qilu Pharmaceutical Co., Ltd, Jinan 250101, China
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

*These authors contributed equally to this article.

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Abstract

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.

Keywords

Biosimilarbevacizumabequivalencenon-squamous NSCLCclinical efficacy

Electronic Supplementary Material

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Cancer Biology & Medicine
Volume 18 Issue 3,
August 2021
Pages 816-824
DOI: 10.20892/j.issn.2095-3941.2020.0212
Cite this article:
Chu T, Lu J, Bi M, et al. 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, 2021, 18(3): 816-824. https://doi.org/10.20892/j.issn.2095-3941.2020.0212

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Received: 06 June 2020
Accepted: 14 August 2020
Published: 01 August 2021
©2021 Cancer Biology & Medicine.

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