Comparison of efficacy and safety of a proposed biosimilar QL1206 with reference denosumab in patients with bone metastasis from breast cancer: A subgroup analysis of a randomized, double-blinded phase III study.

IF 7 2区 医学 Q1 ONCOLOGY
Yaxin Liu, Ruyan Zhang, Xiaojia Wang, Lijun Di, Zhendong Chen, Jingfen Wang, Tao Sun, Qingshan Li, Jing Cheng, Qingyuan Zhang, Xiuwen Wang, Junye Wang, Kangsheng Gu, Shihong Wei, Shuqun Zhang, Xiangcai Wang, Ping Sun, Chunfang Hao, Aimin Zang, Yujie Li, Cuicui Han, Xiaoyan Kang, Yanling Li, Huiping Li
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Abstract

Objective: 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).

Methods: 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).

Results: 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%) vs. -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] vs. -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.

Conclusions: 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.

生物仿制药QL1206与denosumab在乳腺癌骨转移患者中的疗效和安全性比较:一项随机、双盲III期研究的亚组分析。
目的:通过一项随机双盲III期临床试验(No. 11)的亚组分析,评价QL1206(一种denosumab生物类似药,Xgeva®)治疗乳腺癌骨转移(BM)患者的疗效和安全性。NCT04550949)。方法:该亚组分析纳入了参加三期试验的乳腺癌转移性脑转移患者。患者随机(1:1)接受3个周期的QL1206或denosumab(每4周皮下注射120 mg)。随后,他们在40周内接受了10个周期的QL1206 (120 mg),随后进行了20周的安全随访。主要终点是从基线到第13周尿n -末端肽校正肌酐(uNTx/Cr)的百分比变化。结果:乳腺癌队列包括311例患者。在入组时,椎体受累(66.4%)是最常见的BM部位,而27.7%的患者出现≥3个转移性骨病变。在第13周,QL1206显示中位uNTx/Cr降低-69.9%(范围:-98.1%-568.0%),而denosumab为-74.3%(范围:-97.7%-386.3%)。协方差分析显示对数变换变化的可比最小二乘法均值:-1.416[95%置信区间(95% CI): -1.736至-1.096]vs. -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)。在53周的治疗期后,83.6%的患者实现了骨密度改善/疾病稳定。两组间的安全性具有可比性。结论:QL1206在乳腺癌脑转移患者中表现出与参考药denosumab相似的疗效和安全性,支持QL1206作为治疗乳腺癌脑转移的新选择。
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来源期刊
自引率
9.80%
发文量
1726
审稿时长
4.5 months
期刊介绍: Chinese Journal of Cancer Research (CJCR; Print ISSN: 1000-9604; Online ISSN:1993-0631) is published by AME Publishing Company in association with Chinese Anti-Cancer Association.It was launched in March 1995 as a quarterly publication and is now published bi-monthly since February 2013. CJCR is published bi-monthly in English, and is an international journal devoted to the life sciences and medical sciences. It publishes peer-reviewed original articles of basic investigations and clinical observations, reviews and brief communications providing a forum for the recent experimental and clinical advances in cancer research. This journal is indexed in Science Citation Index Expanded (SCIE), PubMed/PubMed Central (PMC), Scopus, SciSearch, Chemistry Abstracts (CA), the Excerpta Medica/EMBASE, Chinainfo, CNKI, CSCI, etc.
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