Biosimilar candidate IBI305 plus paclitaxel/carboplatin for the treatment of non-squamous non-small cell lung cancer
| Autor: | Xing Sun, Guangyu An, Jianying Zhou, Yanqiu Zhao, Mengzhao Wang, Tao Sun, Cuiying Zhang, Yiping Zhang, Gongyan Chen, Lan Yang, Jian Fang, Yong Song, Shegan Gao, Shun Lu, Shiying Yu, Zhongyao Jia, Conghua Xie, Yunpeng Liu, Qitao Yu, Huiping Wan, Ying Yuan, Meiqi Shi, Yi Geng, Xiaodong Mei, Kejing Ying, Jinliang Wang, Baolan Li, Lijun Wang, Biyong Ren, Guosheng Feng, Bangwei Cao, S. Ma, Yanxia Ji, Jiuwei Cui, Zijun Liao, Jie Yu, Bin Wu, Hui Zhou, Huaqing Wang, Linian Huang, Mu Hu, Li Zhang, Nong Yang, Yunpeng Yang, Zhidong Pei, Ying Cheng |
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| Rok vydání: | 2019 |
| Předmět: |
Oncology
medicine.medical_specialty Bevacizumab business.industry Phases of clinical research non-small cell lung cancer (NSCLC) Cancer medicine.disease Carboplatin Vascular endothelial growth factor 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine chemistry 030220 oncology & carcinogenesis Internal medicine medicine Clinical endpoint Original Article 030212 general & internal medicine Lung cancer business medicine.drug |
| Zdroj: | Translational Lung Cancer Research. 8:989-999 |
| ISSN: | 2226-4477 2218-6751 |
| Popis: | 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/. |
| Databáze: | OpenAIRE |
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