单位：[1]Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, SunYat-sen University Cancer Center, Guangzhou 510000, China[2]Department of Respiratory Medicine, Affiliated Hospital of Guangdong MedicalUniversity, Zhanjiang 524002, China[3]Department of Respiratory Medicine, The First Affiliated Hospital of Bengbu Medical College, Bangbu233000, China[4]Department of Oncology, Jiangsu Cancer Hospital, Nanjing 210009, China[5]Department of Oncology, The First Hospital ofChina Medical University, Shenyang 110001, China[6]Department of Respiratory Medicine, Henan Cancer Hospital, Zhengzhou 450003, China河南省肿瘤医院[7]Department of Tumor radiotherapy, The Second Affiliated Hospital of Xingtai Medical College, Xingtai 054000, China[8]Department of Oncology,Shanghai Chest Hospital, Shanghai 200030, China[9]Department of Oncology, Harbin Medical University Cancer Hospital, Harbin 150081,China[10]General Department, Beijing Chest Hospital, Capital Medical University, Beijing 101149, China[11]Department of Oncology, ZhongnanHospital of Wuhan University, Wuhan 430071, China[12]Department of Oncology, Peking University Cancer Hospital, Beijing 100142, China[13]Department of Pulmonary Gastroenterology, Hunan Cancer Hospital, Changsha 410006, China[14]Department of Oncology, Zhejiang CancerHospital, Hangzhou 310022, China浙江省肿瘤医院[15]Department of Oncology, The First Hospital of Jilin University, Changchun 130000, China[16]Departmentof Respiratory Medicine, General Hospital of Eastern Theater Command, Nanjing 210002, China[17]Department of Oncology, Inner MongoliaPeople’s Hospital, Hohhot 010017, China[18]Department of Respiratory Medicine, An Hui Provincial Hospital, Hefei 230000, China[19]Departmentof Oncology, Peking Friendship Hospital, Capital Medical University, Beijing 100050, China首都医科大学附属北京友谊医院[20]Department of Respiratory Medicine, The FirstAffiliated Hospital of Xi’an Jiaotong University, Xi’an 710061, China[21]Department of Oncology, Jilin Cancer Hospital, Changchun 130000, China[22]Department of Respiratory Medicine, Sir Run Shaw Hospital of Zhejiang University School of Medicine, Hangzhou 310016, China[23]Departmentof Internal Medicine, Liaoning Cancer Hospital & Institute, Shenyang 110046, China[24]Department of Respiratory Medicine, Chongqing threeGorges Central Hospital, Chongqing 404000, China[25]Department of Oncology, The Cancer Hospital of Guangxi Zhuang Autonomous Region,Nanning 530000, China[26]Department of Internal Medicine, Shaanxi Provincial Tumor Hospital, Xi’an 710061, China[27]Department of Oncology,Luoyang Central Hospital Affiliated To Zhengzhou University, Luoyang 471009, China[28]Department of Respiratory Medicine, Peking UnionMedical College Hospital, Beijing 100005, China[29]Department of Respiratory Medicine, The First Affiliated Hospital Zhejiang University,Hangzhou 310003, China浙江大学医学院附属第一医院[30]Department of Oncology, Tongji Hospital Tongji Medical College, Huazhong University of Science and Technology,Wuhan 430000, China华中科技大学同济医学院附属同济医院[31]Department of Chemotherapy, The People’s Hospital of Guangxi Zhuang Autonomous Region, Nanning 530000, China[32]Department of Oncology, Jiangxi People’s Hospital, Nanchang 330000, China[33]Department of Oncology, Tianjin People’s Hospital, Tianjin300121, China[34]Department of Oncology, First Affiliated Hospital of Henan University of Science and Technology, Luoyang 471000, China[35]Department of Oncology, General Hospital of PLA, Beijing 100853, China[36]Department of Oncology, Beijing Chao-Yang Hospital, Beijing100020, China北京朝阳医院[37]Department of Oncology, Baoji Central Hospital, Baoji 721008, China[38]Department of Oncology, Handan Central Hospital,Handan 056001, China[39]Department of Oncology, The Second Affiliated Hospital Zhejiang University, Hangzhou 310009, China[40]Department ofOncology, Hangzhou First People’s Hospital, Hangzhou 310002, China[41]Department of Oncology, Linyi People’s Hospital, Linyi 276003, China[42]Department of Chest Surgery, Xuanwu Hospital Capital Medical University, Beijing 100053, China首都医科大学宣武医院[43]Innovent Biologics, Inc., Suzhou 215123,China
Background: Bevacizumab is a monoclonal antibody (mAb) against vascular endothelial growth factor (VEGF) and used for treatments of various cancers. Due to the high casts of bevacizumab treatments, a biosimilar provides an affordable alternative therapy for cancer patients. Methods: In this randomized, double-blind, multicenter, phase 3 study, locally advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) patients with wild-type epidermal growth factor receptor were enrolled and randomized (1:1) into IBI305 or bevacizumab groups. Patients received 6 cycles of paclitaxel/carboplatin plus IBI305 or bevacizumab 15 mg/kg intravenously followed by IBI305 or bevacizumab 7.5 mg/kg maintenance until disease progression, unacceptable toxicity or death. The primary endpoint was confirmed objective response rate (ORR) by an independent radiological review committee (IRRC) and secondary endpoints included disease control rate (DCR), progression-free survival (PFS), duration of response (DOR), overall survival (OS) and safety. Results: A total of 450 NSCLC patients were enrolled (224 in IBI305 group and 226 in bevacizumab group). ORRs were 44.3% for IBI305 and 46.4% for bevacizumab, and the ORR ratio was 0.95 (90% CI: 0.803 to 1.135), within the predefined equivalence margin of 0.75 to 1.33. No significant difference in PFS (7.64 vs. 7.77 m, P=0.9987) was observed between the 2 groups. Serious adverse events (AEs) occurred in 33.5% (75/224) of patients in the IBI305 group and 37.6% (85/226) in the bevacizumab group. AEs >= grade 3 were similar in the IBI305 and bevacizumab groups [84.4% (189/224) vs. 89.8% (203/226), P=0.085]. Conclusions: IBI305 is similar to bevacizumab in terms of efficacy and safety.
第一作者单位：[1]Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, SunYat-sen University Cancer Center, Guangzhou 510000, China
通讯作者：
通讯机构：[1]Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, SunYat-sen University Cancer Center, Guangzhou 510000, China[*1]Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou 510000, China
推荐引用方式(GB/T 7714)：
Yang Yunpeng,Wu Bin,Huang Linian,et al.Biosimilar candidate IBI305 plus paclitaxel/carboplatin for the treatment of non-squamous non-small cell lung cancer[J].TRANSLATIONAL LUNG CANCER RESEARCH.2019,8(6):989-+.doi:10.21037/tlcr.2019.12.23.
APA：
Yang, Yunpeng,Wu, Bin,Huang, Linian,Shi, Meiqi,Liu, Yunpeng...&Zhang, Li.(2019).Biosimilar candidate IBI305 plus paclitaxel/carboplatin for the treatment of non-squamous non-small cell lung cancer.TRANSLATIONAL LUNG CANCER RESEARCH,8,(6)
MLA：
Yang, Yunpeng,et al."Biosimilar candidate IBI305 plus paclitaxel/carboplatin for the treatment of non-squamous non-small cell lung cancer".TRANSLATIONAL LUNG CANCER RESEARCH 8..6(2019):989-+
