mil60 Versus Bevacizumab in Patients With Treatment-naïve Non-squamous Non-small Cell Lung Cancer

Summary

This randomized, double-blind, multi-center phase 3 study is aimed to compare the efficacy and safety of mil60 with bevacizumab as first-line treatment when combined with standard chemotherapy (paclitaxel/carboplatin) in treatment-naive patients with advanced or recurrent non-squamous NSCLC.

Timeline

Start

2017-08-15

Primary completion

2019-08-01

Completion

2021-07-30

Outcome

Met primary endpoint

paper 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). PMID 34841235 ↗

release “两组IREC评估的ORR12比值（含分层因素）为1.14，其90% CI为（0.970，1.332），在预先规定的等效边界内（0.75-1/0.75）。” bettapharma.com ↗

Publications

• Wan R, Dong X, Chen Q, Yu Y, Yang S, Zhang X, Zhang G, Pan Y, Sun S, Zhou C, Hong W, Zhao H, Yang L, Huang L, Wu R, Zang A, Ma R, Wu L, Lv D, Fu X, Han J, Li W, Duan J, Wang K, Jiang O, Chen Y, Guo Z, Gao H, Wen J, Wang S, Zhao E, Li G, Yue L, Liang L, Zeng A, Wang X, Zhu Y, Pan H, Dai Z, Feng W, Zhao G, Lin C, Li C, Li N, Bao Y, Li Y, Su Y, Zhao M, Fang H, Zhu Y, Zhang Y, Ding L, Wang Y, Yuan X, Wang J. 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. EClinicalMedicine. 2021 Nov 19;42:101187. doi: 10.1016/j.eclinm.2021.101187. eCollection 2021 Dec.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bevacizumab	Monoclonal antibody	15 mg/kg	Intravenous
Subject	MIL60	Unknown	7.5 mg/kg	Intravenous

Indications