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

A multicenter clinical study of recombinant anti-RANKL fully human monoclonal antibody injection in the treatment of bone metastases from solid tumors

    摘要
  • 摘要:
    目的 比较LY01011（重组全人源抗RANKL单克隆抗体注射液）与地舒单抗注射液治疗实体瘤骨转移的有效性和安全性。
    方法 开展了一项随机、双盲、阳性药物平行对照、多中心临床试验。共850名受试者被随机分配（1:1比例）至试验组（424名受试者）或对照组（426名受试者）。试验组接受13剂LY01011治疗，对照组先接受3剂地舒单抗治疗，随后再接受10剂LY01011治疗。
    结果 主要疗效指标第13周尿肌酐校正的尿I型胶原交联N端肽（urinary N-terminal telopeptide of type I collagen corrected by urinary creatinine，uNTX/uCr）相对于基线的自然对数变化值。试验组的变化值为−1.740（0.0420），对照组为−1.745 （0.0421）。组间最小二乘均值差为0.005（90%置信区间：−0.088～0.097），表明无统计学显著差异（P>0.05）。安全性方面，包括治疗期间出现的不良事件、实验室检查、生命体征、体格检查和心电图结果，两组间具有可比性（P>0.05）。
    结论 LY01011是地舒单抗注射液的生物类似药，整体安全耐受性良好，安全性较高，临床可继续推广运用。

     

    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 (0.0420) in the experimental group and -1.745 (0.0421) 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.

     

    • HTML全文
    • 参考文献(14)
    • 相关文章
    • 施引文献
  • 资源附件(0)

/

返回文章
返回