Efficacy and Safety of MW032 and Xgeva® in Subjects With Bone Metastases From Solid Tumors

Summary

A multi-center, randomized, double-blind, parallel controlled Phase III clinical study to evaluate the clinical efficacy and safety of MW032 and Xgeva® in patients with bone metastases from solid tumors.

Timeline

Start

2020-03-20

Primary completion

2021-04-29

Completion

2022-01-28

Outcome

Met primary endpoint

paper The 90% CI for the difference (-0.04 to 0.09) was within the equivalence margin (-0.13 to 0.13); PMID 38329745 ↗

Publications

• Zhang S, Yin Y, Xiong H, Wang J, Liu H, Lu J, Zhang Q, Zhang L, Zhong J, Nie J, Lei K, Wang H, Yang S, Yao H, Wu H, Yu D, Ji X, Zhang H, Wu F, Xie W, Li W, Yao W, Zhong D, Sun H, Sun T, Guo Z, Wang R, Guo Y, Yu Z, Li D, Jin H, Song H, Chen X, Ma W, Hu Z, Liu D, Guo Y, Tang J, Jiang Z. Efficacy, Safety, and Population Pharmacokinetics of MW032 Compared With Denosumab for Solid Tumor-Related Bone Metastases: A Randomized, Double-Blind, Phase 3 Equivalence Trial. JAMA Oncol. 2024 Apr 1;10(4):448-455. doi: 10.1001/jamaoncol.2023.6520.

Drugs

Indications