Liu Yaxin, Zhang Ruyan, Wang Xiaojia, Di Lijun, Chen Zhendong, Wang Jingfen, Sun Tao, Li Qingshan, Cheng Jing, Zhang Qingyuan, Wang Xiuwen, Wang Junye, Gu Kangsheng, Wei Shihong, Zhang Shuqun, Wang Xiangcai, Sun Ping, Hao Chunfang, Zang Aimin, Li Yujie, Han Cuicui, Kang Xiaoyan, Li Yanling, Li Huiping
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Breast Oncology, Peking University Cancer Hospital & Institute, Beijing 100142, China.
Breast Medicine, Zhejiang Cancer Hospital, Hangzhou 310022, China.
Chin J Cancer Res. 2025 Jun 30;37(3):337-351. doi: 10.21147/j.issn.1000-9604.2025.03.04.
To evaluate the efficacy and safety of QL1206 (a denosumab biosimilar to Xgeva®) in breast cancer patients with bone metastasis (BM) through subgroup analysis of a randomized, double-blind phase III trial (No. NCT04550949).
This subgroup analysis included patients with BM from breast cancer enrolled in a phase III trial. Patients were randomized (1:1) to receive either three cycles of QL1206 or denosumab (120 mg subcutaneously every 4 weeks). Subsequently, they received 10 cycles of QL1206 (120 mg) over 40 weeks, followed by a 20-week safety follow-up. The primary endpoint was the percentage changes from baseline to week 13 in urinary N-telopeptide corrected for creatinine (uNTx/Cr).
The breast cancer cohort consisted of 311 patients. Vertebral involvement (66.4%) was the most prevalent BM site at enrollment, while 27.7% of patients presented with ≥3 metastatic bone lesions. At week 13, QL1206 demonstrated a median uNTx/Cr reduction of -69.9% (range: -98.1%-568.0%) . -74.3% (range: -97.7%-386.3%) for denosumab. The analysis of covariance revealed comparable least-square means for log-transformed changes: -1.416 [95% confidence interval (95% CI): -1.736 to -1.096] -1.501 (95% CI: -1.824 to -1.178), yielding an between-group difference of 0.085 (90% CI: -0.062-0.232; P=0.343). After a 53-week treatment period, 83.6% achieved bone density improvement/disease stabilization. Safety profiles were comparable between groups.
QL1206 demonstrated similar efficacy and safety to the reference denosumab in patients with BM from breast cancer, supporting QL1206 as a new option for management of BM from breast cancer.
通过一项随机、双盲III期试验（编号NCT04550949）的亚组分析，评估QL1206（一种与安加维®生物类似的地诺单抗）在乳腺癌骨转移（BM）患者中的疗效和安全性。
该亚组分析纳入了参加III期试验的乳腺癌BM患者。患者被随机分组（1:1），接受三个周期的QL1206或地诺单抗治疗（每4周皮下注射120mg）。随后，他们在40周内接受10个周期的QL1206（120mg）治疗，随后进行20周的安全性随访。主要终点是校正肌酐后的尿N-端肽（uNTx/Cr）从基线到第13周的百分比变化。
乳腺癌队列包括311名患者。椎体受累（66.4%）是入组时最常见的BM部位，而27.7%的患者有≥3处转移性骨病变。在第13周时，QL1206组uNTx/Cr的中位数降低了-69.9%（范围：-98.1%-568.0%），地诺单抗组为-74.3%（范围：-97.7%-386.3%）。协方差分析显示，对数转换变化的最小二乘均值具有可比性：-1.416 [95%置信区间（95%CI）：-1.736至-1.096] -1.501（95%CI：-1.824至-1.178），组间差异为0.085（90%CI：-0.062-0.232；P=0.343）。经过53周的治疗期后，83.6%的患者实现了骨密度改善/疾病稳定。两组的安全性概况具有可比性。
QL1206在乳腺癌BM患者中显示出与参比地诺单抗相似的疗效和安全性，支持QL1206作为乳腺癌BM管理的新选择。
