Biosimilar candidate IBI305 plus paclitaxel/carboplatin for the treatment of non-squamous non-small cell lung cancer

Yunpeng Yang, Bin Wu, Linian Huang, Meiqi Shi, Yunpeng Liu, Yanqiu Zhao, Lijun Wang, Shun Lu, Gongyan Chen, Baolan Li, Conghua Xie, Jian Fang, Nong Yang, Yiping Zhang, Jiuwei Cui, Yong Song, Cuiying Zhang, Xiaodong Mei, Bangwei Cao, Lan Yang, Ying Cheng, Kejing Ying, Tao Sun, Biyong Ren, Qitao Yu, Zijun Liao, Zhidong Pei, Mengzhao Wang, Jianying Zhou, Shiying Yu, Guosheng Feng, Huiping Wan, Huaqing Wang, Shegan Gao, Jinliang Wang, Guangyu An, Yi Geng, Yanxia Ji, Ying Yuan, Shenglin Ma, Zhongyao Jia, Mu Hu, Hui Zhou, Jie Yu, Xing Sun, Li Zhang

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/.