Efficacy and safety of JMT103 in patients with unresectable or surgically-challenging giant cell tumor of bone: a multicenter, phase Ib/II study

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.

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Journal
Nature Communications
Published
2024-11-05
DOI
https://doi.org/10.1038/s41467-024-53686-4
Citations
2
Primary Topic
Bone Tumor Diagnosis and Treatments
Type
article
Field-Weighted Citation Impact
0.94
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article

Efficacy and safety of JMT103 in patients with unresectable or surgically-challenging giant cell tumor of bone: a multicenter, phase Ib/II study

Zheng Guo, Jing Yuan, Chongqi Tu, Hairong Xu et al.
2 citations
Nature Communications
Bone Tumor Diagnosis and Treatments
0.94
article

Efficacy and safety of JMT103 in patients with unresectable or surgically-challenging giant cell tumor of bone: a multicenter, phase Ib/II study

Zheng Guo, Jing Yuan, Chongqi Tu, Hairong Xu, Dong Wang, Jilong Yang, Caigang Liu, Wenzhi Bi, Xiaohui Niu, Wangjun Yan, Jingnan Shen, Guofan Qu, Jin Wang, Zhaoming Ye, Yong Zhou, Hong Li, Jianmin Li, Wei Feng, Liang Li, Xiao‐Jing Zhang, Weifeng Liu, Yanbin Xiao, Jianhua Lin, Gang Huang, Zhichao Tong, Guochuan Zhang, Wenxian Zhou, Zhengfu Fan, Weitao Yao, Qing Zhang
article en
2 citations

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.

Nature CommunicationsVol. 15(1)
Hebei Medical University (CN), Fujian Medical University (CN), Guiyang Medical University (CN), Harbin Medical University (CN), Sun Yat-sen University (CN), Guangxi Medical University (CN), Capital Medical University (CN), Peking University (CN), Sichuan University (CN), Tianjin Medical University Cancer Institute and Hospital (CN), Chinese PLA General Hospital (CN), Beijing Jishuitan Hospital (CN), Zhengzhou University (CN), Third Hospital of Hebei Medical University (CN), West China Hospital of Sichuan University (CN), Second People's Hospital of Yunnan Province (CN), Fudan University Shanghai Cancer Center (CN), Peking University Cancer Hospital (CN), Xi'an Honghui Hospital (CN), Third Affiliated Hospital of Harbin Medical University (CN), Xi'an Medical University (CN), Hunan Cancer Hospital (CN), First Affiliated Hospital of Fujian Medical University (CN), The First Affiliated Hospital, Sun Yat-sen University (CN), Peking University Third Hospital (CN), Henan Cancer Hospital (CN), Sun Yat-sen University Cancer Center (CN), Second Affiliated Hospital of Zhejiang University (CN), Liaoning Cancer Hospital & Institute (CN), Qilu Hospital of Shandong University (CN), CSPC Pharmaceutical Group (CN), Xi'an Jiaotong University (CN), China Medical University (CN), Air Force Medical University (CN)
Good health and well-being
Openalex Percentile: Top 22%
Bone Tumor Diagnosis and Treatments
0.94
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