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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

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收录情况： ◇ SCIE

作者：
Cheng, Ying[1] * ; Pan, Zhanyu[2] ; Wu, Lin[3] ; Zhu, Bo[4] ; Yu, Yan[5] ; Zang, Kai[6] ; Zhuang, Wu[7] ; Liu, Lianke[8] ; Gu, Kangsheng[9] ; Lian, Juanwen[10] ; Chen, Rixin[11] ; Bian, Tao[12] ; Lin, Dang[13] ; Sun, Shenghua[14] ; Li, Wei[15] ; Hang, Xiaosheng[16] ; Jiang, Ou[17] ; Zhong, Fukuan[18] ; Wang, Rui[19] ; Luo, Hui[20] ; Shi, Huaqiu[21] ; Wei, Zonghui[22] ; Zhao, Li[23] ; Chen, Shaoshui[24] ; Sun, Hongmei[25] ; Li, Xingya[26] ; Sun, Debin[27] ; Ren, Tiejun[28] ; Lei, Kaijian[29] ; He, Miao[30] ; Li, Gaofeng[31] ; Liu, Hailong[32] ; Li, Runpu[33] ; Hu, Chunhong[34] ; Kong, Li[35] ; Sun, Meili[36] ; Xie, Liangzhi[37] ; Gai, Wenlin[37] ; Chen, Weiqiu[37] ; Huang, Zhe[37] ; Ren, Wenwen[37] ; Su, Huo[37] ;
机构： [1]Jilin Canc Hosp, 1066 Jinhu Rd, Changchun 130000, Changchun, Peoples R China [2]Tianjin Canc Hosp, Tianjin, Peoples R China [3]Cent South Univ, Affiliated Canc Hosp, Xiangya Sch Med, Hunan Canc Hosp, Changsha, Peoples R China [4]Xi An Jiao Tong Univ, Affiliated Hosp 1, Xian, Peoples R China [5]Harbin Med Univ, Canc Hosp, Harbin, Peoples R China [6]Henan Canc Hosp, Zhengzhou, Peoples R China [7]Fujian Canc Hosp, Fuzhou, Peoples R China [8]Jiang Su Prov Hosp, Nanjing, Peoples R China [9]Anhui Med Univ, Affiliated Hosp 1, Hefei, Peoples R China [10]Xian Chest Hosp, Xian, Peoples R China [11]Liuzhou Peoples Hosp, Liuzhou, Peoples R China [12]Wuxi Peoples Hosp, Wuxi, Peoples R China [13]Nanjing Med Univ, Affiliated Suzhou Hosp, Suzhou, Peoples R China [14]Cent South Univ, Xiangya Hosp 3, Changsha, Peoples R China [15]Bengbu Med Coll, Affiliated Hosp 1, Bengbu, Peoples R China [16]Jiangnan Univ, Affiliated Hosp, Wuxi, Peoples R China [17]Second Peoples Hosp Neijiang, Neijiang, Peoples R China [18]Second Peoples Hosp Lianyungang, Lianyungang, Peoples R China [19]Anhui Chest Hosp, Hefei, Peoples R China [20]Jiangxi Canc Hosp, Thorac Oncol Radiotherapy Dept, Nanchang, Peoples R China [21]Gannan Med Coll, Affiliated Hosp 1, Ganzhou, Peoples R China [22]Chongqing Nanchuan Dist Peoples Hosp, Chongqing, Peoples R China [23]China Med Univ, Shengjing Hosp, Liaoning, Peoples R China [24]Binzhou Med Univ Hosp, Binzhou, Peoples R China [25]Jiamusi Cent Hosp, Jiamusi, Peoples R China [26]Zhengzhou Univ, Affiliated Hosp 1, Oncol Dept, Zhengzhou, Peoples R China [27]Cent Hosp Lishui City, Lishui, Peoples R China [28]Luoyang Cent Hosp, Luoyang, Peoples R China [29]Second Peoples Hosp Yibin, Yibin, Peoples R China [30]Deyang Peoples Hosp, Deyang, Peoples R China [31]Kunming Med Univ, Affiliated Hosp 3, Yunnan Tumor Hosp, Kunming, Peoples R China [32]First Peoples Hosp Chenzhou, Chenzhou, Peoples R China [33]Baoding Second Cent Hosp, Zhuozhou, Peoples R China [34]Cent South Univ, Xiangya Hosp 2, Changsha, Peoples R China [35]Shandong Canc Hosp, Jinan, Peoples R China [36]Jinan Cent Hosp, Jinan, Peoples R China [37]Sinocelltech Ltd, Beijing Engn Res Ctr Prot & Antibody, Beijing, Peoples R China
出处：
DOI： 10.1007/s12325-024-02965-z
ISSN：

关键词： Non-small cell lung cancer SCT510 Immunotherapy Randomized controlled trial

摘要：
IntroductionSCT510 is a biosimilar to bevacizumab (Avastin) reference product (RP) that is approved for various metastatic cancers. In this study, we aimed to demonstrate the equivalence of SCT510 and bevacizumab in terms of efficacy, safety, immunogenicity and pharmacokinetics (PK) in patients with advanced non-squamous non-small cell lung cancer (NSCLC).MethodsPatients with non-squamous NSCLC were randomized equally to the SCT510 group (comprising SCT510, paclitaxel, and carboplatin) and the bevacizumab group (comprising bevacizumab, paclitaxel, and carboplatin) for 4-6 cycles, followed by maintenance monotherapy with SCT510. The primary endpoint was the objective response rate (ORR) at week 12. Secondary endpoints included 18-week ORR, disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and 1-year survival rate, as well as assessments of safety, immunogenicity, and multi-dose PK analysis.ResultsBetween March 29, 2019, and April 27, 2021, 989 patients were screened and 567 eligible patients were randomly assigned to the SCT510 group (285 patients) and the bevacizumab group (282 patients). The ORR at week 12 was 52.6% [95% confidence interval (CI) 46.66-58.55%] in the SCT510 group and 52.5% (95% CI 46.47-58.47%) in the bevacizumab group. The ORR at week 18 was 55.4% (95% CI 49.46-61.30%) for SCT510 and 55.7% (95% CI 49.68-61.62%) for bevacizumab. The ORR risk ratio (RR) at weeks 12 and 18 was 0.99 (90% CI 0.873-1.133) and 0.99 (90% CI 0.872-1.114), respectively, both within the pre-specified equivalence margin of 0.75-1.33. There were no differences between the two groups in relation to other secondary endpoints, specifically DCR, DOR, PFS, OS, and 1-year survival rate. The overall safety findings were similar between the two treatment groups, and both SCT510 and bevacizumab RP exhibited low immunogenicity.ConclusionsSCT510 is similar to bevacizumab in clinical efficacy, safety, immunogenicity, and PK in patients with advanced non-squamous NSCLC. The totality of the evidence supports the clinical equivalence of SCT510 and bevacizumab.Trial RegistrationNCT03792074.

基金：
Funding for this work and publication costs, including the journal’s Rapid Service Fee, was provided by Sinocelltech Ltd. and by the National Science and Technology Major Projects of China (Grant No. 2018ZX09736002).
语种：
外文
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出版当年[2024]版：
无
最新[2023]版：
大类 | 3 区 医学
小类 | 3 区 医学：研究与实验 3 区 药学
JCR分区：
出版当年[2023]版：
Q2 MEDICINE, RESEARCH & EXPERIMENTAL Q2 PHARMACOLOGY & PHARMACY
最新[2023]版：
Q2 MEDICINE, RESEARCH & EXPERIMENTAL Q2 PHARMACOLOGY & PHARMACY

影响因子： 最新[2023版] 最新五年平均 出版当年[2023版] 出版当年五年平均 出版前一年[2022版]

第一作者：
第一作者机构： [1]Jilin Canc Hosp, 1066 Jinhu Rd, Changchun 130000, Changchun, Peoples R China
通讯作者：
推荐引用方式(GB/T 7714)：
Cheng Ying,Pan Zhanyu,Wu Lin,et al.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[J].ADVANCES IN THERAPY.2024,41(11):4032-4048.doi:10.1007/s12325-024-02965-z.
APA：
Cheng, Ying,Pan, Zhanyu,Wu, Lin,Zhu, Bo,Yu, Yan...&Su, Huo.(2024).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.ADVANCES IN THERAPY,41,(11)
MLA：
Cheng, Ying,et al."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".ADVANCES IN THERAPY 41..11(2024):4032-4048

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