Author
Listed:
- Hairong Xu
(Capital Medical University)
- Yong Zhou
(West China Hospital, Sichuan University)
- Li Liang
(Peking University Third Hospital)
- Jingnan Shen
(The First Affiliated Hospital of Sun Yat-Sen University)
- Wangjun Yan
(Fudan University Shanghai Cancer Center)
- Jin Wang
(Sun Yat-Sen University Cancer Center)
- Jianmin Li
(Qilu Hospital of Shandong University)
- Xiaojing Zhang
(Liaoning Cancer Hospital and Institute)
- Gang Huang
(Hunan Cancer Hospital)
- Wenzhi Bi
(The Fourth Medical Center, Chinese PLA General Hospital)
- Zheng Guo
(The Second Affiliated Hospital of Air Force Medical University)
- Yanbin Xiao
(Yunnan Cancer Hospital)
- Jianhua Lin
(The First Affiliated Hospital of Fujian Medical University)
- Weitao Yao
(The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital)
- Zhichao Tong
(Xi’an Jiaotong University)
- Wenxian Zhou
(Guangxi Medical University Cancer Hospital)
- Guochuan Zhang
(The Third Hospital of Hebei Medical University)
- Zhaoming Ye
(The Second Affiliated Hospital of Zhejiang University School of Medicine)
- Dong Wang
(Affiliated Cancer Hospital of Guizhou Medical University)
- Jilong Yang
(Tianjin Medical University Cancer Institute & Hospital)
- Zhengfu Fan
(Peking University Cancer Hospital)
- Caigang Liu
(Shengjing Hospital of China Medical University)
- Guofan Qu
(Harbin Medical University Cancer Hospital)
- Qing Zhang
(Capital Medical University)
- Feng Wei
(Peking University Third Hospital
Peking University Third Hospital)
- Weifeng Liu
(Capital Medical University)
- Chongqi Tu
(West China Hospital, Sichuan University)
- Hong Li
(CSPC Pharmaceutical Group Limited)
- Jing Yuan
(CSPC Pharmaceutical Group Limited)
- Xiaohui Niu
(Capital Medical University)
Abstract
This was a multicenter, single-arm, open-label, phase Ib/II study (NCT04255576), aimed to evaluate the efficacy and safety of JMT103 in patients with unresectable or surgically-challenging giant cell tumor of bone (GCTB). JMT103 (2 mg/kg) was administered subcutaneously every four weeks, with loading doses on days 8 and 15. The primary endpoint was the objective tumor response rate (OTR) based on best response, defined as the proportion of patients who achieved elimination of at least 90% of the giant cells or radiologic complete or partial response per the modified Inverse Choi density/size (mICDS) or modified European Organization for Research and Treatment of Cancer (mEORTC) within 12 weeks. Secondary endpoints included objective response rate (ORR) per mICDS and mEORTC, and safety. A total of 139 patients were enrolled, and 135 were analyzed for efficacy. OTR, determined by the independent review committee (IRC) was 93.3% (95% CI 87.7-96.9). Treatment-related adverse events occurred in 90 (64.7%) patients, with hypophosphatemia and hypocalcemia being the most common. No serious treatment-related adverse events were observed. Thus, JMT103 demonstrates potential as a therapeutic option for GCTB.
Suggested Citation
Hairong Xu & Yong Zhou & Li Liang & Jingnan Shen & Wangjun Yan & Jin Wang & Jianmin Li & Xiaojing Zhang & Gang Huang & Wenzhi Bi & Zheng Guo & Yanbin Xiao & Jianhua Lin & Weitao Yao & Zhichao Tong & W, 2024.
"Efficacy and safety of JMT103 in patients with unresectable or surgically-challenging giant cell tumor of bone: a multicenter, phase Ib/II study,"
Nature Communications, Nature, vol. 15(1), pages 1-9, December.
Handle:
RePEc:nat:natcom:v:15:y:2024:i:1:d:10.1038_s41467-024-53686-4
DOI: 10.1038/s41467-024-53686-4
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