Bevacizumab biosimilar LY01008 compared with bevacizumab (Avastin) as first‐line treatment for Chinese patients with unresectable, metastatic, or recurrent non‐squamous non–small‐cell lung cancer: A multicenter, randomized, double‐blinded, phase III trial

作者：Yuankai Shi, Kaijian Lei, Yuming Jia, Bingqiang Ni, Zhiyong He, Minghong Bi, Xicheng Wang, Jianhua Shi, Ming Zhou, Qian Sun, Guolei Wang, Dongji Chen, Yongqian Shu, Lianke Liu, Zhongliang Guo, Yong Liu, Junquan Yang, Ke Wang, Ke Xiao, Lin Wu, Tienan Yi, Debin Sun, Mafei Kang, Tianjiang Ma, Yimin Mao, Jinsheng Shi, Tiegang Tang, Yan Wang, Puyuan Xing, Dongqing Lv, Wangjun Liao, Zhiguo Luo, Bin Wang, Xiaohong Wu, Xiaoli Zhu, Shuhua Han, Qisen Guo, Rong‐Yu Liu, Zhiwei Lu, Jianyong Zhang, Jian Fang, Chang-Lu Hu, Yinghua Ji, Guolong Liu, Hong Lu, Dedong Wu, Junhong Zhang, Shuyang Zhu, Zheng Liu, Wensheng Qiu, Feng Ye, Yan Yu, Yanqiu Zhao, Qinhong Zheng, Jun Chen, Zhanyu Pan, Yiping Zhang, Wenjuan Lian, Bo Jiang, Bo Qiu, Guojun Zhang, Hua Zhang, Yanju Chen, Yuan Chen, Hongbing Duan, Manxiang Li, Shengming Liu, Lijun Ma, Hongming Pan, Xia Yuan, Xueli Yuan, Yulong Zheng, Emei Gao, Li Zhao, Shumin Wang, Can Wu · 发表于：癌症：英文版 · 年份：2021 · DOI：10.1002/cac2.12179 · 被引用次数：25 · 研究领域：Biosimilars and Bioanalytical Methods、Colorectal Cancer Treatments and Studies、Cancer Immunotherapy and Biomarkers

Abstract Background Previous studies have demonstrated the preclinical pharmacological and toxicological consistency, and clinical pharmacokinetic equivalence of bevacizumab biosimilar LY01008 with reference bevacizumab (Avastin). This randomized controlled trial aimed to compare the efficacy and safety of LY01008 with Avastin in first‐line treatment of Chinese patients with advanced or recurrent non‐squamous non‐small cell lung cancer (NSCLC). Methods Stage IIIB‐IV NSCLC patients with evaluable lesions, good physical status, and adequate organ functions from 67 centers across China were randomized in a ratio of 1:1 to receive LY01008 or Avastin 15 mg/kg intravenously in combination with paclitaxel/carboplatin (combined treatment) for 4‐6 cycles, followed by maintenance monotherapy with LY01008 until disease progression, intolerable toxicity, or death. The primary endpoint was objective response rate (ORR) in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 confirmed by independent radiological review committees (IRRC). Secondary endpoints included disease control rate (DCR), duration of response (DoR), progression‐free survival (PFS), overall survival (OS), and safety. This study was registered in ClinicalTrials.gov (NCT03533127). Results Between December 15 th , 2017, and May 15 th , 2019, a total of 649 patients were randomized to the LY01008 ( n = 324) or Avastin ( n = 325) group. As of September 25 th , 2019 for primary endpoint analysis,...