Efficacy, Safety, and Population Pharmacokinetics of MW032 Compared With Denosumab for Solid Tumor–Related Bone Metastases

• DOI: 10.1001/jamaoncol.2023.6520
• Publication Date: 2024-02-08T16:05:01Z
• Authors: Shaohua Zhang; Yongmei Yin; Hailin Xiong; Jingfen Wang; Hu Liu; Junguo Lu; Qingyuan Zhang; Longzhen Zhang; Jincai Zhong; Jianyun Nie; Kaijian Lei; Hong Wang; Shu Yang; Herui Yao; Huijing Wu; Ding Yu; Xuening Ji; Hua Zhang; Fang Wu; Weimin Xie; Wei Li; Weirong Yao; Diansheng Zhong; Hongmei Sun; Tao Sun; Zengqing Guo; Rui Wang; Yanzhen Guo; Zhuang Yu; Dairong Li; Hongyan Jin; Haifeng Song; Xiaoyuan Chen; Wen Ma; Zhitian Hu; Datao Liu; Yinhan Guo; Jinhai Tang; Zefei Jiang
• Keywords: Denosumab; Clinical endpoint

Importance The bioequivalence of denosumab biosimilar has yet to be studied in a 53-week, multicenter, large-scale, and head-to-head trial. A clinically effective may help increase access patients with solid tumor–related bone metastases. Objectives To establish the biosimilarity MW032 metastases based on large-scale study. Design, Setting, Participants In this randomized, double-blind, phase 3 equivalence trial, tumors metastasis were recruited from 46 clinical sites China. Overall, 856 screened 708 eligible randomly allocated receive either or denosumab. Interventions Patients assigned (1:1) reference subcutaneously every 4 weeks until week 49. Main Outcomes Measures primary end point was percentage change baseline 13 natural logarithmic transformed urinary N-telopeptide/creatinine ratio (uNTx/uCr). Results Among 701 evaluable (350 group 351 group), mean (range) age 56.1 (22.0-86.0) years 460 women (65.6%). uNTx/uCr −72.0% (95% CI, −73.5% −70.4%) −72.7% −74.2% −71.2%) group. These percent changes corresponded ratios −1.27 −1.30, difference 0.02. 90% CI for (−0.04 0.09) within margin (−0.13 0.13); bone-specific alkaline phosphatase (s-BALP) at each time also similar during 53 weeks. differences 0.015 −0.06 0.09), −0.02 −0.09 0.06), −0.05 −0.13 0.03) 0.001 −0.10 0.10) 5, 25, 37, 53, respectively. s-BALP −0.006 0.06 0.05), 0.00 −0.07 0.07), −0.085 −0.18 0.01), −0.20 0.02), −0.27 0.004) 13, 37 No significant observed incidence skeletal-related events (−1.4%; 95% −5.8% 3.0%) first on-study (unadjusted HR, 0.86; P = .53; multiplicity adjusted 0.87; .55) 2 groups. Conclusions Relevance efficacy, population pharmacokinetics, safety profile. Availability biosimilars broaden reduce drug burden advanced tumors. Trial Registration ClinicalTrials.gov Identifier: NCT04812509