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. 2019 Dec;8(6):989-999.
doi: 10.21037/tlcr.2019.12.23.

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

Yunpeng Yang  1 , Bin Wu  2 , Linian Huang  3 , Meiqi Shi  4 , Yunpeng Liu  5 , Yanqiu Zhao  6 , Lijun Wang  7 , Shun Lu  8 , Gongyan Chen  9 , Baolan Li  10 , Conghua Xie  11 , Jian Fang  12 , Nong Yang  13 , Yiping Zhang  14 , Jiuwei Cui  15 , Yong Song  16 , Cuiying Zhang  17 , Xiaodong Mei  18 , Bangwei Cao  19 , Lan Yang  20 , Ying Cheng  21 , Kejing Ying  22 , Tao Sun  23 , Biyong Ren  24 , Qitao Yu  25 , Zijun Liao  26 , Zhidong Pei  27 , Mengzhao Wang  28 , Jianying Zhou  29 , Shiying Yu  30 , Guosheng Feng  31 , Huiping Wan  32 , Huaqing Wang  33 , Shegan Gao  34 , Jinliang Wang  35 , Guangyu An  36 , Yi Geng  37 , Yanxia Ji  38 , Ying Yuan  39 , Shenglin Ma  40 , Zhongyao Jia  41 , Mu Hu  42 , Hui Zhou  43 , Jie Yu  43 , Xing Sun  43 , Li Zhang  1
Affiliations

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

Yunpeng Yang et al. Transl Lung Cancer Res. 2019 Dec.

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/.

Keywords: Bevacizumab; IBI305; biosimilar; non-small cell lung cancer (NSCLC); vascular endothelial growth factor (VEGF).

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Conflict of interest statement

Conflicts of Interest: L Zhang received research grants from Eli Lily and Pfizer. H Zhou, J Yu and X Sun are staff of Innovent Biologics, Inc. The other authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1
Flowchart of patient enrollment, distribution, and discontinuation of treatment.
Figure 2
Figure 2
Long-term efficacy comparison between two groups. (A) Kaplan-Meier estimate of progression-free survival; (B) Kaplan-Meier estimate of overall survival.
Figure S1
Figure S1
ORR subgroup analyses. ORR, objective response rate.
Figure S2
Figure S2
(A) Blood concentrations of IBI305 and bevacizumab over time, and (B) changes in plasma VEGF concentrations compared to baseline at different time points. Bars are SDs. VEGF, vascular endothelial growth factor; SD, standard deviation.
Figure S3
Figure S3
Comparison of the incidence of AESIs in the IBI305 and bevacizumab groups. AESI, adverse events of special interest.
See this image and copyright information in PMC

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