TY - JOUR AU - Yang, Yunpeng AU - Wu, Bin AU - Huang, Linian AU - Shi, Meiqi AU - Liu, Yunpeng AU - Zhao, Yanqiu AU - Wang, Lijun AU - Lu, Shun AU - Chen, Gongyan AU - Li, Baolan AU - Xie, Conghua AU - Fang, Jian AU - Yang, Nong AU - Zhang, Yiping AU - Cui, Jiuwei AU - Song, Yong AU - Zhang, Cuiying AU - Mei, Xiaodong AU - Cao, Bangwei AU - Yang, Lan AU - Cheng, Ying AU - Ying, Kejing AU - Sun, Tao AU - Ren, Biyong AU - Yu, Qitao AU - Liao, Zijun AU - Pei, Zhidong AU - Wang, Mengzhao AU - Zhou, Jianying AU - Yu, Shiying AU - Feng, Guosheng AU - Wan, Huiping AU - Wang, Huaqing AU - Gao, Shegan AU - Wang, Jinliang AU - An, Guangyu AU - Geng, Yi AU - Ji, Yanxia AU - Yuan, Ying AU - Ma, Shenglin AU - Jia, Zhongyao AU - Hu, Mu AU - Zhou, Hui AU - Yu, Jie AU - Sun, Xing AU - Zhang, Li PY - 2019 TI - Biosimilar candidate IBI305 plus paclitaxel/carboplatin for the treatment of non-squamous non-small cell lung cancer JF - Translational Lung Cancer Research; Vol 8, No 6 (December 31, 2019): Translational Lung Cancer Research Y2 - 2019 KW - N2 - Background: Bevacizumab is a monoclonal antibody (mAb) against vascular endothelial growth factor (VEGF) and used for treatments of various cancers. Due to the high costs 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. Trial registration: Clinicaltrials.org Identifier: NCT02954172. Registered on 3 November 2016. Https:// clinicaltrials.gov/. UR - https://tlcr.amegroups.org/article/view/34338