Efficacy and safety of MIL60 compared with bevacizumab in advanced or recurrent non-squamous non-small cell lung cancer: a phase 3 randomized, double-blind study.
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Wan Rui, Dong Xiaorong, Chen Qun, Yu Yan, Yang Shujun, Zhang Xiaochun, Zhang Guojun, Pan Yueyin, Sun Sanyuan, Zhou Chengzhi, Hong Wei, Zhao Hui, Yang Lei, Huang Linian, Wu Rong, Zang Aimin, Ma Rui, Wu Lin, Lv Dongqing, Fu Xiuhua, Han Jianguo, Li Wenxin, Duan Jianchun, Wang Kai, Jiang Ou, Chen Yinglan, Guo Zhongliang, Gao Hongjun, Wen Juyi, Wang Shubin, Zhao Enfeng, Li Gaofeng, Yue Lu, Liang Li, Zeng Aiping, Wang Xiaoshan, Zhu Yuxi, Pan Hongming, Dai Zhaoxia, Feng Weineng, Zhao Guofang, Lin Chuan, Li Chong, Li Na, Bao Yangyi, Li Yinyin, Su Yanjun, Zhao Min, Fang Haohui, Zhu Yulong, Zhang Yu, Ding Lieming, Wang Yang, Yuan Xiaobin, Wang Jie
Аннотация
METHODS: Patients with untreated advanced or recurrent NSCLC were randomized (1:1 ratio) to receive either MIL60 or bevacizumab in combination with paclitaxel/carboplatin. Patients with non-progressive disease continued maintenance single-agent MIL60 until disease progression, or intolerable toxicity. The primary endpoint was the 12-week objective response rates (ORR12) by independent review committee (IRC) using RECIST 1.1. Bioequivalence was established if the ORR ratio located between 0.75 and 1/0.75. The trial was registered with clinicaltrials.gov (NCT03196986).
FINDINGS: Between Aug 23, 2017, and May 8, 2019, 517 patients were randomly assigned to MIL60 group (n=257) and bevacizumab group (n=260). In the full analysis set (FAS) population including all randomized and evaluable patients who received at least one dose of MIL60 or bevacizumab, the ORR12 in MIL60 group and bevacizumab group were 48.6% and 43.1%, respectively. The ORR ratio of these two groups were 1.14 (90% CI 0.97-1.33), which fell within the pre-specified equivalence boundaries (0.75-1/0.75). The median DOR was 5.7 months (95% CI 4.5-6.2) for MIL60 and 5.6 months (95% CI 4.3-6.4) for bevacizumab. No significant difference was noted in median PFS (7.2 vs. 8.1 months; HR 1.01, 95% CI 0.78-1.30, p=0.9606) and OS (19.3 vs. 16.3 months; HR 0.81, 95% CI 0.64-1.02, p=0.0755). Safety and tolerability profiles were similar between the two groups. No patient detected positive for Anti-drug antibody (ADA).
INTERPRETATION: The efficacy, safety and immunogenicity of MIL60 were similar with bevacizumab, providing an alternative treatment option for advanced or recurrent non-squamous NSCLC.
FUNDING: This study was sponsored by Betta Pharmaceutical Co., Ltd.