@article{TLCR34338,
author = {Yunpeng Yang and Bin Wu and Linian Huang and Meiqi Shi and Yunpeng Liu and Yanqiu Zhao and Lijun Wang and Shun Lu and Gongyan Chen and Baolan Li and Conghua Xie and Jian Fang and Nong Yang and Yiping Zhang and Jiuwei Cui and Yong Song and Cuiying Zhang and Xiaodong Mei and Bangwei Cao and Lan Yang and Ying Cheng and Kejing Ying and Tao Sun and Biyong Ren and Qitao Yu and Zijun Liao and Zhidong Pei and Mengzhao Wang and Jianying Zhou and Shiying Yu and Guosheng Feng and Huiping Wan and Huaqing Wang and Shegan Gao and Jinliang Wang and Guangyu An and Yi Geng and Yanxia Ji and Ying Yuan and Shenglin Ma and Zhongyao Jia and Mu Hu and Hui Zhou and Jie Yu and Xing Sun and Li Zhang},
title = {Biosimilar candidate IBI305 plus paclitaxel/carboplatin for the treatment of non-squamous non-small cell lung cancer},
journal = {Translational Lung Cancer Research},
volume = {8},
number = {6},
year = {2019},
keywords = {},
abstract = {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/.},
issn = {2226-4477}, url = {https://tlcr.amegroups.org/article/view/34338}
}