A multicenter clinical study of recombinant anti-RANKL fully human monoclonal anti-body injection in the treatment of bone metastases from solid tumors
10.12354/j.issn.1000-8179.2025.20250100
- VernacularTitle:重组抗RANKL全人单克隆抗体注射液治疗实体瘤骨转移的多中心临床研究
- Author:
Wang HONG
1
;
Hu YAQI
;
Luo YUANFEI
;
Zeng ZHIWEN
;
Liu QING
;
Huang LINRU
;
Wan LIJIAO
;
Wu LIPING
Author Information
1. 南昌市人民医院肿瘤科(南昌市 330009)
- Publication Type:Journal Article
- Keywords:
recombinant anti-RANKL fully human monoclonal antibody injection(LY01011);
bone metastasis of solid tumors;
clinical tri-al;
efficacy;
safety
- From:
Chinese Journal of Clinical Oncology
2025;52(13):656-659
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To compare the efficacy and safety of LY01011,a recombinant anti-RANKL fully human monoclonal antibody injection,versus denosumab in the treatment of bone metastases from solid tumors.Methods:A randomized,double-blind,positive drug parallel-controlled,multicenter clinical trial was conducted.A total of 850 subjects were randomly assigned(1:1)to either the experimental group(424 subjects)or the control group(426 subjects).The experimental group received 13 doses of LY01011,while the control group received 3 doses of denosumab followed by 10 doses of LY01011.Results:The primary efficacy endpoint was the natural logarithmic change from baseline in urinary N-terminal telopeptide of type I collagen corrected by urinary creatinine(uNTX/uCr)at week 13.The change was-1.740(0.042 0)in the experimental group and-1.745(0.042 1)in the control group.The least-squares mean difference between groups was 0.005(90%CI:-0.088 to 0.097),indicating no statistically significant difference(P>0.05).Safety profiles,including treatment-emergent adverse events,laboratory tests,vital signs,physical examinations,and electrocardiograms,were comparable between groups(P>0.05).Conclusions:LY01011 demonstrated biosimilarity to denosumab,with favorable safety profile,tolerability,and potential for clinical application.
