Clinical Trial

. 2021 Sep;41(9):889-903.

doi: 10.1002/cac2.12179. Epub 2021 Jun 29.

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

Yuankai Shi¹, Kaijian Lei², Yuming Jia², Bingqiang Ni³, Zhiyong He⁴, Minghong Bi⁵, Xicheng Wang⁶, Jianhua Shi⁷, Ming Zhou⁸, Qian Sun⁹, Guolei Wang⁹, Dongji Chen¹⁰, Yongqian Shu¹¹, Lianke Liu¹¹, Zhongliang Guo¹², Yong Liu¹³, Junquan Yang¹⁴, Ke Wang¹⁵, Ke Xiao¹⁶, Lin Wu¹⁷, Tienan Yi¹⁸, Debin Sun¹⁹, Mafei Kang²⁰, Tianjiang Ma²¹, Yimin Mao²², Jinsheng Shi²³, Tiegang Tang²⁴, Yan Wang¹, Puyuan Xing¹, Dongqing Lv²⁵, Wangjun Liao²⁶, Zhiguo Luo²⁷, Bin Wang²⁸, Xiaohong Wu²⁹, Xiaoli Zhu³⁰, Shuhua Han³⁰, Qisen Guo³¹, Rongyu Liu³², Zhiwei Lu³³, Jianyong Zhang³⁴, Jian Fang³⁵, Changlu Hu³⁶, Yinghua Ji³⁷, Guolong Liu³⁸, Hong Lu³⁹, Dedong Wu⁴⁰, Junhong Zhang⁴¹, Shuyang Zhu⁴², Zheng Liu⁴³, Wensheng Qiu⁴⁴, Feng Ye⁴⁵, Yan Yu⁴⁶, Yanqiu Zhao⁴⁷, Qinhong Zheng⁴⁸, Jun Chen⁴⁹, Zhanyu Pan⁵⁰, Yiping Zhang⁵¹, Wenjuan Lian⁵², Bo Jiang⁵³, Bo Qiu⁵⁴, Guojun Zhang⁵⁵, Hua Zhang⁵⁶, Yanju Chen⁵⁷, Yuan Chen⁵⁸, Hongbing Duan⁵⁹, Manxiang Li⁶⁰, Shengming Liu⁶¹, Lijun Ma⁶², Hongming Pan⁶³, Xia Yuan⁶⁴, Xueli Yuan⁶⁵, Yulong Zheng⁶⁶, Emei Gao⁶⁷, Li Zhao⁶⁷, Shumin Wang⁶⁷, Can Wu⁶⁷

Affiliations

¹ Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, 100021, P. R. China.
² Department of Oncology, Yibin Second People's Hospital, Yibin, Sichuan, 644000, P. R. China.
³ Department of Oncology, Liuzhou People's Hospital, Liuzhou, Guangxi, 545006, P. R. China.
⁴ Department of Thoracic Oncology, Fujian Provincial Cancer Hospital, Fuzhou, Fujian, 350014, P. R. China.
⁵ Oncology Department, the First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, 233030, P. R. China.
⁶ Department of Oncology, the First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, Guangdong, 510030, P. R. China.
⁷ Department of Internal medicine, Linyi Cancer Hospital, Linyi, Shandong, 276002, P. R. China.
⁸ Department of Thoracic Surgery, the Affiliated Cancer Hospital of Guangzhou Medical University, Guangzhou, Guangdong, 510095, P. R. China.
⁹ Department of Internal Medicine-Oncology/Department of thoracic oncology, Henan Chest Hospital, Zhengzhou, Henan, 450003, P. R. China.
¹⁰ The Second Department of Radiotherapy, Wuwei Cancer Hospital of Gansu Province, Wuwei, Gansu, 730000, P. R. China.
¹¹ Department of Oncology, the People's Hospital of Jiangsu Province, Nanjing, Jiangsu, 210000, P. R. China.
¹² Respiratory Medicine Department, Shanghai East Hospital, Shanghai, 200120, P. R. China.
¹³ The Second Department of Internal Medicine-Oncology, Xuzhou Central Hospital, Xuzhou, Jiangsu, 221009, P. R. China.
¹⁴ Oncology Department, Tangshan People's Hospital, Tangshan, Hebei, 063001, P. R. China.
¹⁵ Respiratory Medicine Department, West China Hospital of Sichuan University, Chengdu, Sichuan, 610041, P. R. China.
¹⁶ Thoracic Surgery, the Second Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong, 515051, P. R. China.
¹⁷ Internal Medicine-Oncology, Hunan Cancer Hospital, Changsha, Hunan, 410013, P. R. China.
¹⁸ Department of Oncology, Xiangyang Central Hospital, Xiangyang, Hubei, 441021, P. R. China.
¹⁹ Respiratory Department, Lishui Central Hospital, Lishui, Zhejiang, 323000, P. R. China.
²⁰ Oncology Department, The Affiliated Hospital of Guilin Medical College, Guilin, Guangxi, 541001, P. R. China.
²¹ Internal Medicine-Oncology, Luohe Central Hospital, Luohe, Henan, 462000, P. R. China.
²² Respiratory Department, the First Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, 471003, P. R. China.
²³ Oncology Department, Cangzhou People's Hospital, Cangzhou, Hebei, 061000, P. R. China.
²⁴ Oncology Department, Xiangtan Central Hospital, Xiangtan, Hunan, 411100, P. R. China.
²⁵ Respiratory Department, Taizhou Hospital of Zhejiang Province, Taizhou, Zhejiang, 317000, P. R. China.
²⁶ Department of Oncology, Nanfang Hospital of Southern Medical University, Guangzhou, Guangdong, 510515, P. R. China.
²⁷ Department of Oncology, Taihe Hospital of Shiyan City, Shiyan, Hubei, 442000, P. R. China.
²⁸ Respiratory Department, Huzhou Central Hospital, Huzhou, Zhejiang, 313003, P. R. China.
²⁹ Internal Medicine-Oncology, the Fourth People's Hospital of Wuxi City, Wuxi, Jiangsu, 214062, P. R. China.
³⁰ Department of Oncology, Zhongda Hospital of Southeast University, Nanjing, Jiangsu, 210009, P. R. China.
³¹ The Second Department of Internal Medicine, Shandong Cancer Hospital, Jinan, Shandong, 250117, P. R. China.
³² Respiratory Department, the First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230022, P. R. China.
³³ Respiratory Department, The First Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, 241001, P. R. China.
³⁴ The Second Department of Respiratory Medicine, the Affiliated Hospital of Zunyi Medical College, Zunyi, Guizhou, 563099, P. R. China.
³⁵ The Second Department of thoracic oncology, Beijing Cancer Hospital, Beijing, 100142, P. R. China.
³⁶ Department of Oncology, Anhui Cancer Hospital, Hefei, Anhui, 233004, P. R. China.
³⁷ Oncology Department, the First Affiliated Hospital of Xinxiang Medical College, Xinxiang, Henan, 453100, P. R. China.
³⁸ Department of Oncology, the First People's Hospital of Guangzhou, Guangzhou, Guangdong, 510180, P. R. China.
³⁹ Oncology Department, Huaihe Hospital of Henan University, Kaifeng, Henan, 475000, P. R. China.
⁴⁰ Department of Oncology and Hematology, The First People's Hospital of Zhengzhou, Zhengzhou, Henan, 450004, P. R. China.
⁴¹ Oncology Department, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, 430071, P. R. China.
⁴² Respiratory Department, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, 221006, P. R. China.
⁴³ The Third Department of Oncology, Handan Central Hospital, Handan, Hebei, 056001, P. R. China.
⁴⁴ Oncology Department, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, 266011, P. R. China.
⁴⁵ Oncology Department, the First Affiliated Hospital of Xiamen University, Xiamen, Fujian, 361003, P. R. China.
⁴⁶ The Sixth Department of Internal Medicine, the Affiliated Cancer Hospital of Harbin Medical University, Harbin, Heilongjiang, 150081, P. R. China.
⁴⁷ Respiratory Department, Henan Cancer Hospital, Zhengzhou, Henan, 450008, P. R. China.
⁴⁸ Internal Medicine-Oncology, Quzhou People's Hospital, Quzhou, Zhejiang, 324000, P. R. China.
⁴⁹ Lung tumor surgery Department, General Hospital of Tianjin Medical University, Tianjin, 300052, P. R. China.
⁵⁰ Integrated Traditional Chinese and Western Medicine Department, Tianjin Cancer Hospital, Tianjin, 300060, P. R. China.
⁵¹ Department of Thoracic Cancer, Zhejiang Cancer Hospital, Hangzhou, Zhejiang, 310022, P. R. China.
⁵² Department of Oncology, Xi'an Chest Hospital, Xi'an, Shanxi, 710061, P. R. China.
⁵³ Special Medical Treatment, Yunnan Cancer Hospital, Kunming, Yunnan, 650106, P. R. China.
⁵⁴ Department of Oncology, Zhuzhou Central Hospital, Zhuzhou, Hunan, 412007, P. R. China.
⁵⁵ Respiratory Department, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450052, P. R. China.
⁵⁶ Second Department of Cancer Center, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, 830054, P. R. China.
⁵⁷ Internal Medicine-Oncology, Hainan Provincial People's Hospital, Haikou, Hainan, 570311, P. R. China.
⁵⁸ Oncology Department, Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430030, P. R. China.
⁵⁹ Thoracic Surgery, Zhongshan Hospital Affiliated to Xiamen University, Xiamen, Fujian, 361004, P. R. China.
⁶⁰ Respiratory Department, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shanxi, 710061, P. R. China.
⁶¹ Respiratory Department, The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong, 510632, P. R. China.
⁶² Oncology Department, Shanghai Tongren Hospital, Shanghai, 200336, P. R. China.
⁶³ Internal Medicine-Oncology, Shaoyifu Hospital Affiliated to Medical College of Zhejiang University, Hangzhou, Zhejiang, 310016, P. R. China.
⁶⁴ Internal Medicine-Oncology, Huizhou Central People's Hospital, Huizhou, Guangdong, 516008, P. R. China.
⁶⁵ Oncology Department, the Fourth Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, 150001, P. R. China.
⁶⁶ Respiratory Department, Huai'an Second People's Hospital, Huai'an, Jiangsu, 223002, P. R. China.
⁶⁷ Clinical Research Center of Luye Pharma Group Ltd, Luye Life Sciences Group, Beijing, 100025, P. R. China.

PMID: 34184418
PMCID: PMC8441057
DOI: 10.1002/cac2.12179

Clinical Trial

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

Yuankai Shi et al. Cancer Commun (Lond). 2021 Sep.

. 2021 Sep;41(9):889-903.

doi: 10.1002/cac2.12179. Epub 2021 Jun 29.

Authors

Affiliations

¹ Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, 100021, P. R. China.
² Department of Oncology, Yibin Second People's Hospital, Yibin, Sichuan, 644000, P. R. China.
³ Department of Oncology, Liuzhou People's Hospital, Liuzhou, Guangxi, 545006, P. R. China.
⁴ Department of Thoracic Oncology, Fujian Provincial Cancer Hospital, Fuzhou, Fujian, 350014, P. R. China.
⁵ Oncology Department, the First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, 233030, P. R. China.
⁶ Department of Oncology, the First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, Guangdong, 510030, P. R. China.
⁷ Department of Internal medicine, Linyi Cancer Hospital, Linyi, Shandong, 276002, P. R. China.
⁸ Department of Thoracic Surgery, the Affiliated Cancer Hospital of Guangzhou Medical University, Guangzhou, Guangdong, 510095, P. R. China.
⁹ Department of Internal Medicine-Oncology/Department of thoracic oncology, Henan Chest Hospital, Zhengzhou, Henan, 450003, P. R. China.
¹⁰ The Second Department of Radiotherapy, Wuwei Cancer Hospital of Gansu Province, Wuwei, Gansu, 730000, P. R. China.
¹¹ Department of Oncology, the People's Hospital of Jiangsu Province, Nanjing, Jiangsu, 210000, P. R. China.
¹² Respiratory Medicine Department, Shanghai East Hospital, Shanghai, 200120, P. R. China.
¹³ The Second Department of Internal Medicine-Oncology, Xuzhou Central Hospital, Xuzhou, Jiangsu, 221009, P. R. China.
¹⁴ Oncology Department, Tangshan People's Hospital, Tangshan, Hebei, 063001, P. R. China.
¹⁵ Respiratory Medicine Department, West China Hospital of Sichuan University, Chengdu, Sichuan, 610041, P. R. China.
¹⁶ Thoracic Surgery, the Second Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong, 515051, P. R. China.
¹⁷ Internal Medicine-Oncology, Hunan Cancer Hospital, Changsha, Hunan, 410013, P. R. China.
¹⁸ Department of Oncology, Xiangyang Central Hospital, Xiangyang, Hubei, 441021, P. R. China.
¹⁹ Respiratory Department, Lishui Central Hospital, Lishui, Zhejiang, 323000, P. R. China.
²⁰ Oncology Department, The Affiliated Hospital of Guilin Medical College, Guilin, Guangxi, 541001, P. R. China.
²¹ Internal Medicine-Oncology, Luohe Central Hospital, Luohe, Henan, 462000, P. R. China.
²² Respiratory Department, the First Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, 471003, P. R. China.
²³ Oncology Department, Cangzhou People's Hospital, Cangzhou, Hebei, 061000, P. R. China.
²⁴ Oncology Department, Xiangtan Central Hospital, Xiangtan, Hunan, 411100, P. R. China.
²⁵ Respiratory Department, Taizhou Hospital of Zhejiang Province, Taizhou, Zhejiang, 317000, P. R. China.
²⁶ Department of Oncology, Nanfang Hospital of Southern Medical University, Guangzhou, Guangdong, 510515, P. R. China.
²⁷ Department of Oncology, Taihe Hospital of Shiyan City, Shiyan, Hubei, 442000, P. R. China.
²⁸ Respiratory Department, Huzhou Central Hospital, Huzhou, Zhejiang, 313003, P. R. China.
²⁹ Internal Medicine-Oncology, the Fourth People's Hospital of Wuxi City, Wuxi, Jiangsu, 214062, P. R. China.
³⁰ Department of Oncology, Zhongda Hospital of Southeast University, Nanjing, Jiangsu, 210009, P. R. China.
³¹ The Second Department of Internal Medicine, Shandong Cancer Hospital, Jinan, Shandong, 250117, P. R. China.
³² Respiratory Department, the First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230022, P. R. China.
³³ Respiratory Department, The First Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, 241001, P. R. China.
³⁴ The Second Department of Respiratory Medicine, the Affiliated Hospital of Zunyi Medical College, Zunyi, Guizhou, 563099, P. R. China.
³⁵ The Second Department of thoracic oncology, Beijing Cancer Hospital, Beijing, 100142, P. R. China.
³⁶ Department of Oncology, Anhui Cancer Hospital, Hefei, Anhui, 233004, P. R. China.
³⁷ Oncology Department, the First Affiliated Hospital of Xinxiang Medical College, Xinxiang, Henan, 453100, P. R. China.
³⁸ Department of Oncology, the First People's Hospital of Guangzhou, Guangzhou, Guangdong, 510180, P. R. China.
³⁹ Oncology Department, Huaihe Hospital of Henan University, Kaifeng, Henan, 475000, P. R. China.
⁴⁰ Department of Oncology and Hematology, The First People's Hospital of Zhengzhou, Zhengzhou, Henan, 450004, P. R. China.
⁴¹ Oncology Department, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, 430071, P. R. China.
⁴² Respiratory Department, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, 221006, P. R. China.
⁴³ The Third Department of Oncology, Handan Central Hospital, Handan, Hebei, 056001, P. R. China.
⁴⁴ Oncology Department, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, 266011, P. R. China.
⁴⁵ Oncology Department, the First Affiliated Hospital of Xiamen University, Xiamen, Fujian, 361003, P. R. China.
⁴⁶ The Sixth Department of Internal Medicine, the Affiliated Cancer Hospital of Harbin Medical University, Harbin, Heilongjiang, 150081, P. R. China.
⁴⁷ Respiratory Department, Henan Cancer Hospital, Zhengzhou, Henan, 450008, P. R. China.
⁴⁸ Internal Medicine-Oncology, Quzhou People's Hospital, Quzhou, Zhejiang, 324000, P. R. China.
⁴⁹ Lung tumor surgery Department, General Hospital of Tianjin Medical University, Tianjin, 300052, P. R. China.
⁵⁰ Integrated Traditional Chinese and Western Medicine Department, Tianjin Cancer Hospital, Tianjin, 300060, P. R. China.
⁵¹ Department of Thoracic Cancer, Zhejiang Cancer Hospital, Hangzhou, Zhejiang, 310022, P. R. China.
⁵² Department of Oncology, Xi'an Chest Hospital, Xi'an, Shanxi, 710061, P. R. China.
⁵³ Special Medical Treatment, Yunnan Cancer Hospital, Kunming, Yunnan, 650106, P. R. China.
⁵⁴ Department of Oncology, Zhuzhou Central Hospital, Zhuzhou, Hunan, 412007, P. R. China.
⁵⁵ Respiratory Department, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450052, P. R. China.
⁵⁶ Second Department of Cancer Center, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, 830054, P. R. China.
⁵⁷ Internal Medicine-Oncology, Hainan Provincial People's Hospital, Haikou, Hainan, 570311, P. R. China.
⁵⁸ Oncology Department, Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430030, P. R. China.
⁵⁹ Thoracic Surgery, Zhongshan Hospital Affiliated to Xiamen University, Xiamen, Fujian, 361004, P. R. China.
⁶⁰ Respiratory Department, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shanxi, 710061, P. R. China.
⁶¹ Respiratory Department, The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong, 510632, P. R. China.
⁶² Oncology Department, Shanghai Tongren Hospital, Shanghai, 200336, P. R. China.
⁶³ Internal Medicine-Oncology, Shaoyifu Hospital Affiliated to Medical College of Zhejiang University, Hangzhou, Zhejiang, 310016, P. R. China.
⁶⁴ Internal Medicine-Oncology, Huizhou Central People's Hospital, Huizhou, Guangdong, 516008, P. R. China.
⁶⁵ Oncology Department, the Fourth Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, 150001, P. R. China.
⁶⁶ Respiratory Department, Huai'an Second People's Hospital, Huai'an, Jiangsu, 223002, P. R. China.
⁶⁷ Clinical Research Center of Luye Pharma Group Ltd, Luye Life Sciences Group, Beijing, 100025, P. R. China.

PMID: 34184418
PMCID: PMC8441057
DOI: 10.1002/cac2.12179

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, 589 patients received ORR evaluation, with a median number of combined treatment cycles of 5 (range 1-6) and median duration of treatment of 3.0 (range 0.0-5.1) months. ORR of response-evaluable patients in the LY01008 and Avastin groups were 48.5% and 53.0%, respectively. The stratified ORR ratio was 0.91 (90% CI 0.80-1.04, within the prespecified equivalence margin of 0.75-1.33). Up to May 15^th , 2020, with a median follow-up of 13.6 (range 0.8-28.4) months, no notable differences in DCR, median DoR, median PFS, median OS, and 1-year OS rate were observed between the LY01008 and Avastin groups. There were no clinically meaningful differences in safety and immunogenicity across treatment groups.

Conclusions: LY01008 demonstrated similarity to Avastin in terms of efficacy and safety in Chinese patients with advanced or recurrent non-squamous NSCLC. LY01008 combined with paclitaxel/carboplatin is expected to become a new treatment option for unresectable, metastatic, or recurrent non-squamous NSCLC patients in the first-line setting.

Keywords: LY01008; anti-VEGF monoclonal antibody; anti-angiogenesis; avastin; bevacizumab; biosimilar; non-small cell lung cancer; vascular endothelial growth factor.

PubMed Disclaimer

Conflict of interest statement

The tested drug LY01008 in this study is the product of Luye Pharma Group Ltd., which provided main funding to this study. Emei Gao, Li Zhao, Shumin Wang, and Can Wu are employees of the Clinical Research Center of Luye Pharma Group Ltd., Luye Life Sciences Group, Beijing, China. All other authors declare that they have no conflict of interests.

Figures

**FIGURE 1**
Flowchart of participants’ disposition. Abbreviations: ITT, intention‐to‐treat; ORR, objective response rate; FAS, full analysis set; PPS, per‐protocol set

**FIGURE 2**
Forest plot for subgroup analysis of objective response rate in the full analysis set. Abbreviations: CI: confidence interval; ECOG: Eastern Cooperative Oncology Group; PS: performance status; EGFR, epidermal growth factor receptor

**FIGURE 3**
Kaplan‐Meier curves of the LY01008 group and the Avastin group in the full analysis set. A: Percentage rate of patients with a duration of response; B: Progression‐free survival; C: Overall survival. Abbreviations: CI, confidence interval; mDoR, median duration of response; mPFS, median progression‐free survival; mOS, median overall survival; NR, not reached

See this image and copyright information in PMC

Cited by

Landscape of the clinical development of China innovative anti-lung cancer drugs.
Shi Y. Shi Y. Cancer Pathog Ther. 2022 Oct 11;1(1):67-75. doi: 10.1016/j.cpt.2022.10.003. eCollection 2023 Jan. Cancer Pathog Ther. 2022. PMID: 38328605 Free PMC article. Review.
Comparison of efficacy and safety of bevacizumab biosimilar and original bevacizumab in non-squamous non-small cell lung cancer: a systematic review and meta-analysis.
Xiao X, Zhang G, Sun B, Wang C, Wang X, Kong F, Jia Y. Xiao X, et al. Transl Cancer Res. 2022 Jun;11(6):1472-1482. doi: 10.21037/tcr-22-71. Transl Cancer Res. 2022. PMID: 35836506 Free PMC article.
Efficacy and Safety of Biosimilar SCT510 Compared with Bevacizumab for the First-Line Treatment of Advanced Non-Squamous Non-Small Cell Lung Cancer: A Randomized, Double-Blind, Phase III Study.
Cheng Y, Pan Z, Wu L, Zhu B, Yu Y, Zang K, Zhuang W, Liu L, Gu K, Lian J, Chen R, Bian T, Lin D, Sun S, Li W, Hang X, Jiang O, Zhong F, Wang R, Luo H, Shi H, Wei Z, Zhao L, Chen S, Sun H, Li X, Sun D, Ren T, Lei K, He M, Li G, Liu H, Li R, Hu C, Kong L, Sun M, Xie L, Gai W, Chen W, Huang Z, Ren W, Su H. Cheng Y, et al. Adv Ther. 2024 Nov;41(11):4032-4048. doi: 10.1007/s12325-024-02965-z. Epub 2024 Sep 4. Adv Ther. 2024. PMID: 39230871 Clinical Trial.
Clinical and cost-effectiveness analysis of mFOLOFX6 with or without a targeted drug among patients with metastatic colorectal cancer: inverse probability of treatment weighting.
Tsai HL, Shi HY, Chen YC, Huang CW, Su WC, Chang TK, Li CC, Chen PJ, Yeh YS, Yin TC, Wang JY. Tsai HL, et al. Am J Cancer Res. 2023 Sep 15;13(9):4039-4056. eCollection 2023. Am J Cancer Res. 2023. PMID: 37818063 Free PMC article.
Efficacy and safety of adding bevacizumab biosimilar or original drug to platinum-based chemotherapy as first-line treatment in patients with advanced NSCLC: a systematic review and meta-analysis.
Yang L, Liu M, Cao X, Li N, Zheng B, Deng J, Cai H. Yang L, et al. Ther Adv Med Oncol. 2022 Oct 20;14:17588359221130501. doi: 10.1177/17588359221130501. eCollection 2022. Ther Adv Med Oncol. 2022. PMID: 36312816 Free PMC article.

See all "Cited by" articles

References

1. Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209–49. - PubMed
1. Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, et al. Cancer statistics in China, 2015. CA Cancer J Clin. 2016;66(2):115–32. - PubMed
1. Cao M, Li H, Sun D, Chen W. Cancer burden of major cancers in China: a need for sustainable actions. Cancer Commun (Lond). 2020;40(5):205–10. - PMC - PubMed
1. Reck M, Heigener DF, Mok T, Soria JC, Rabe KF. Management of non‐small‐cell lung cancer: recent developments. Lancet. 2013;382(9893):709–19. - PubMed
1. Yang P, Allen MS, Aubry MC, Wampfler JA, Marks RS, Edell ES, et al. Clinical features of 5,628 primary lung cancer patients: experience at Mayo Clinic from 1997 to 2003. Chest. 2005;128(1):452–62. - PubMed

Publication types

Actions
Actions
Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Substances

Actions
Actions

Associated data

Actions
- Search in PubMed
- Search in ClinicalTrials.gov

Grants and funding

LinkOut - more resources

Full Text Sources
Medical
- ClinicalTrials.gov
- MedlinePlus Health Information
Research Materials
- NCI CPTC Antibody Characterization Program

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

Similar articles

Cited by

References

Publication types

MeSH terms

Substances

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Medical

Research Materials

Abstract

Conflict of interest statement

Figures

Similar articles

Cited by

References

Publication types

MeSH terms

Substances

Associated data

Related information

Grants and funding

LinkOut - more resources

Full Text Sources

Medical

Research Materials