A multicenter, randomized, double-blind trial comparing LY01011, a biosimilar, with denosumab (Xgeva®) in patients with bone metastasis from solid tumors
Introduction: Denosumab (Xgeva®) is a standard treatment for the prevention of skeletal-related events (SREs) in patients with bone metastases (BM). This trial was designed to assess the equivalence of LY01011 to denosumab in terms of efficacy and safety. Materials and methods: Eligible patients wit...
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Elsevier
2025-04-01
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| Series: | Journal of Bone Oncology |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2212137425000028 |
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| author | Mingchuan Zhao Xichun Hu Pengpeng Zhuang Aiping Zeng Yan Yu Zhendong Chen Hongmei Sun Weihua Yang Lili Sheng Peijian Peng Jingfen Wang Tienan Yi Minghong Bi Huaqiu Shi Mingli Ni Xiumei Dai Changlu Hu Hongjie Xu Dongqing Lv Qingshan Li Kaijian Lei Xia Yuan Ou Jiang Xicheng Wang Baihui Hu Zhe Hou Zhaoping Su Song Zheng Ming Zhou Changlin Dou |
| author_facet | Mingchuan Zhao Xichun Hu Pengpeng Zhuang Aiping Zeng Yan Yu Zhendong Chen Hongmei Sun Weihua Yang Lili Sheng Peijian Peng Jingfen Wang Tienan Yi Minghong Bi Huaqiu Shi Mingli Ni Xiumei Dai Changlu Hu Hongjie Xu Dongqing Lv Qingshan Li Kaijian Lei Xia Yuan Ou Jiang Xicheng Wang Baihui Hu Zhe Hou Zhaoping Su Song Zheng Ming Zhou Changlin Dou |
| author_sort | Mingchuan Zhao |
| collection | DOAJ |
| description | Introduction: Denosumab (Xgeva®) is a standard treatment for the prevention of skeletal-related events (SREs) in patients with bone metastases (BM). This trial was designed to assess the equivalence of LY01011 to denosumab in terms of efficacy and safety. Materials and methods: Eligible patients with BM from solid tumors were randomized at a 1:1 ratio to receive 120 mg of LY01011 or 120 mg of denosumab subcutaneously every four weeks during a 12-week double-blind treatment period, and then all enrolled patients continued to receive LY01011 until week 53. The primary endpoint was the natural logarithm of change of the urinary N-terminal crosslinked telopeptide of type I collagen level normalized to the urine creatinine level (uNTX/uCr) at week 13 from baseline. Other endpoints included the uNTX/uCr ratio, serum bone-specific alkaline phosphatase level alteration, status of anti-drug antibodies and neutralizing antibodies, adverse events and SREs. Results: 850 eligible patients were randomized into the LY01011 group (n = 424) or the denosumab group (n = 426). The least-squares means (SEs) of the natural logarithms of the changes in the uNTX/uCr ratios at week 13 from baseline were −1.810 (0.0404) in the LY01011 group and −1.791 (0.0406) in the denosumab group. The LSM difference [90 % CI] between two arms was −0.019 [-0.110, 0.073] within the equivalence margins (−0.135, 0.135) and met the predetermined primary endpoint. The AEs, ADAs and the PK data showed no statistically significant difference. Conclusions: This study demonstrated the equivalent efficacy and safety of LY01011 to denosumab in patients with BM. |
| format | Article |
| id | doaj-art-0398a5e03c8f4d1f94ce50480a4db62d |
| institution | Kabale University |
| issn | 2212-1374 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Journal of Bone Oncology |
| spelling | doaj-art-0398a5e03c8f4d1f94ce50480a4db62d2025-02-08T05:00:22ZengElsevierJournal of Bone Oncology2212-13742025-04-0151100661A multicenter, randomized, double-blind trial comparing LY01011, a biosimilar, with denosumab (Xgeva®) in patients with bone metastasis from solid tumorsMingchuan Zhao0Xichun Hu1Pengpeng Zhuang2Aiping Zeng3Yan Yu4Zhendong Chen5Hongmei Sun6Weihua Yang7Lili Sheng8Peijian Peng9Jingfen Wang10Tienan Yi11Minghong Bi12Huaqiu Shi13Mingli Ni14Xiumei Dai15Changlu Hu16Hongjie Xu17Dongqing Lv18Qingshan Li19Kaijian Lei20Xia Yuan21Ou Jiang22Xicheng Wang23Baihui Hu24Zhe Hou25Zhaoping Su26Song Zheng27Ming Zhou28Changlin Dou29Fudan University Shanghai Cancer Center, PR ChinaFudan University Shanghai Cancer Center, PR China; Corresponding author.Shandong Boan Biotechnology Co., Ltd., PR ChinaAffiliated Tumor Hospital of Guangxi Medical University, PR ChinaHarbin Medical University Cancer Hospital, PR Chinathe Second Affiliated Hospital of Anhui Medical University, PR ChinaJiamusi Cancer Hospital, PR ChinaShanxi Provincial Cancer Hospital, PR ChinaThe First Affiliated Hospital of Wannan Medical College Yijishan Hospital, PR ChinaFifth Affiliated Hospital of Sun Yat-sen University, PR ChinaLinyi Cancer hospital, PR ChinaXiangyang Central Hospital, PR ChinaThe First Affiliated Hospital of Bengbu Medical College, Bengbu, PR ChinaFirst Affiliated Hospital of Gannan Medical University, PR ChinaLuoyang Central Hospital Affiliated to Zhengzhou University, PR ChinaXuzhou Central Hospital, PR ChinaDepartment of Medical Oncology, Anhui Provincial Cancer Hospital, PR ChinaThe Affiliated Hospital of Bei-hua University, PR ChinaTaizhou hospital of Zhejiang Province, PR ChinaAffiliated Hospital of Chengde Medical University, PR ChinaSecond People’s Hospital of Yibin, PR ChinaHuizhou Central People’s Hospital, PR ChinaThe Second People’s Hospital of Neijiang, PR ChinaThe First Affiliated Hospital/School of Clinical Medicine of Guangdong Pharmaceutical University, PR ChinaShandong Luye Pharmaceutical Co., Ltd., PR ChinaShandong Boan Biotechnology Co., Ltd., PR ChinaShandong Boan Biotechnology Co., Ltd., PR ChinaShandong Luye Pharmaceutical Co., Ltd., PR ChinaShandong Boan Biotechnology Co., Ltd., PR ChinaShandong Boan Biotechnology Co., Ltd., PR ChinaIntroduction: Denosumab (Xgeva®) is a standard treatment for the prevention of skeletal-related events (SREs) in patients with bone metastases (BM). This trial was designed to assess the equivalence of LY01011 to denosumab in terms of efficacy and safety. Materials and methods: Eligible patients with BM from solid tumors were randomized at a 1:1 ratio to receive 120 mg of LY01011 or 120 mg of denosumab subcutaneously every four weeks during a 12-week double-blind treatment period, and then all enrolled patients continued to receive LY01011 until week 53. The primary endpoint was the natural logarithm of change of the urinary N-terminal crosslinked telopeptide of type I collagen level normalized to the urine creatinine level (uNTX/uCr) at week 13 from baseline. Other endpoints included the uNTX/uCr ratio, serum bone-specific alkaline phosphatase level alteration, status of anti-drug antibodies and neutralizing antibodies, adverse events and SREs. Results: 850 eligible patients were randomized into the LY01011 group (n = 424) or the denosumab group (n = 426). The least-squares means (SEs) of the natural logarithms of the changes in the uNTX/uCr ratios at week 13 from baseline were −1.810 (0.0404) in the LY01011 group and −1.791 (0.0406) in the denosumab group. The LSM difference [90 % CI] between two arms was −0.019 [-0.110, 0.073] within the equivalence margins (−0.135, 0.135) and met the predetermined primary endpoint. The AEs, ADAs and the PK data showed no statistically significant difference. Conclusions: This study demonstrated the equivalent efficacy and safety of LY01011 to denosumab in patients with BM.http://www.sciencedirect.com/science/article/pii/S2212137425000028Bone metastasisBreast cancerDenosumabLY01011Receptor activator of NF-κB ligand (RANKL)Urinary N-telopeptide to urinary creatinine (uNTx/uCr) ratio |
| spellingShingle | Mingchuan Zhao Xichun Hu Pengpeng Zhuang Aiping Zeng Yan Yu Zhendong Chen Hongmei Sun Weihua Yang Lili Sheng Peijian Peng Jingfen Wang Tienan Yi Minghong Bi Huaqiu Shi Mingli Ni Xiumei Dai Changlu Hu Hongjie Xu Dongqing Lv Qingshan Li Kaijian Lei Xia Yuan Ou Jiang Xicheng Wang Baihui Hu Zhe Hou Zhaoping Su Song Zheng Ming Zhou Changlin Dou A multicenter, randomized, double-blind trial comparing LY01011, a biosimilar, with denosumab (Xgeva®) in patients with bone metastasis from solid tumors Journal of Bone Oncology Bone metastasis Breast cancer Denosumab LY01011 Receptor activator of NF-κB ligand (RANKL) Urinary N-telopeptide to urinary creatinine (uNTx/uCr) ratio |
| title | A multicenter, randomized, double-blind trial comparing LY01011, a biosimilar, with denosumab (Xgeva®) in patients with bone metastasis from solid tumors |
| title_full | A multicenter, randomized, double-blind trial comparing LY01011, a biosimilar, with denosumab (Xgeva®) in patients with bone metastasis from solid tumors |
| title_fullStr | A multicenter, randomized, double-blind trial comparing LY01011, a biosimilar, with denosumab (Xgeva®) in patients with bone metastasis from solid tumors |
| title_full_unstemmed | A multicenter, randomized, double-blind trial comparing LY01011, a biosimilar, with denosumab (Xgeva®) in patients with bone metastasis from solid tumors |
| title_short | A multicenter, randomized, double-blind trial comparing LY01011, a biosimilar, with denosumab (Xgeva®) in patients with bone metastasis from solid tumors |
| title_sort | multicenter randomized double blind trial comparing ly01011 a biosimilar with denosumab xgeva r in patients with bone metastasis from solid tumors |
| topic | Bone metastasis Breast cancer Denosumab LY01011 Receptor activator of NF-κB ligand (RANKL) Urinary N-telopeptide to urinary creatinine (uNTx/uCr) ratio |
| url | http://www.sciencedirect.com/science/article/pii/S2212137425000028 |
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