生物类似药候选药物 IBI305 联合紫杉醇/卡铂用于治疗非鳞状非小细胞肺癌。
Biosimilar candidate IBI305 plus paclitaxel/carboplatin for the treatment of non-squamous non-small cell lung cancer.
作者信息
Yang Yunpeng, Wu Bin, Huang Linian, Shi Meiqi, Liu Yunpeng, Zhao Yanqiu, Wang Lijun, Lu Shun, Chen Gongyan, Li Baolan, Xie Conghua, Fang Jian, Yang Nong, Zhang Yiping, Cui Jiuwei, Song Yong, Zhang Cuiying, Mei Xiaodong, Cao Bangwei, Yang Lan, Cheng Ying, Ying Kejing, Sun Tao, Ren Biyong, Yu Qitao, Liao Zijun, Pei Zhidong, Wang Mengzhao, Zhou Jianying, Yu Shiying, Feng Guosheng, Wan Huiping, Wang Huaqing, Gao Shegan, Wang Jinliang, An Guangyu, Geng Yi, Ji Yanxia, Yuan Ying, Ma Shenglin, Jia Zhongyao, Hu Mu, Zhou Hui, Yu Jie, Sun Xing, Zhang Li
机构信息
Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou 510000, China.
Department of Respiratory Medicine, Affiliated Hospital of Guangdong Medical University, Zhanjiang 524002, China.
出版信息
Transl Lung Cancer Res. 2019 Dec;8(6):989-999. doi: 10.21037/tlcr.2019.12.23.
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 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) 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/.
背景
贝伐单抗是一种抗血管内皮生长因子（VEGF）的单克隆抗体，用于治疗多种癌症。由于贝伐单抗治疗费用高昂，生物类似药为癌症患者提供了一种经济实惠的替代疗法。
方法
在这项随机、双盲、多中心3期研究中，纳入了野生型表皮生长因子受体的局部晚期、转移性或复发性非鳞状非小细胞肺癌（NSCLC）患者，并将其随机（1:1）分为IBI305组或贝伐单抗组。患者接受6个周期的紫杉醇/卡铂加IBI305或静脉注射15 mg/kg贝伐单抗治疗，随后接受7.5 mg/kg的IBI305或贝伐单抗维持治疗，直至疾病进展、出现不可接受的毒性或死亡。主要终点是由独立放射学审查委员会（IRRC）确认的客观缓解率（ORR），次要终点包括疾病控制率（DCR）、无进展生存期（PFS）、缓解持续时间（DOR）、总生存期（OS）和安全性。
结果
共纳入450例NSCLC患者（IBI305组224例，贝伐单抗组226例）。IBI305组的ORR为44.3%，贝伐单抗组为46.4%，ORR比值为0.95（90%CI：0.803至1.135），在预先定义的等效区间0.75至1.33内。两组之间的PFS无显著差异（7.64对7.77个月，P = 0.9987）。IBI305组33.5%（75/224）的患者和贝伐单抗组37.6%（85/226）的患者发生了严重不良事件（AE）。≥3级AE在IBI305组和贝伐单抗组中相似[84.4%（189/224）对89.8%（203/226），P = 0.085]。
结论
IBI305在疗效和安全性方面与贝伐单抗相似。
试验注册
Clinicaltrials.org标识符：NCT02954172。于2016年11月3日注册。Https://clinicaltrials.gov/
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