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Clinical Trial
. 2024 Nov 5;15(1):9541.
doi: 10.1038/s41467-024-53686-4.

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

Hairong Xu  1 , Yong Zhou  2 , Li Liang  3 , Jingnan Shen  4 , Wangjun Yan  5 , Jin Wang  6 , Jianmin Li  7 , Xiaojing Zhang  8 , Gang Huang  9 , Wenzhi Bi  10 , Zheng Guo  11 , Yanbin Xiao  12 , Jianhua Lin  13 , Weitao Yao  14 , Zhichao Tong  15 , Wenxian Zhou  16 , Guochuan Zhang  17 , Zhaoming Ye  18 , Dong Wang  19 , Jilong Yang  20 , Zhengfu Fan  21 , Caigang Liu  22 , Guofan Qu  23 , Qing Zhang  1 , Feng Wei  3   24 , Weifeng Liu  1 , Chongqi Tu  2 , Hong Li  25 , Jing Yuan  25 , Xiaohui Niu  26
Affiliations
Clinical Trial

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

Hairong Xu et al. Nat Commun. .

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.

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Conflict of interest statement

J.Y. and H.L. are employees of the CSPC Pharmaceutical Group Limited. All other authors declare no competing interests.

Figures

Fig. 1
Fig. 1. Patient disposition.
A total of 139 patients were enrolled, including 127 surgical-challenging patients and 12 unresectable patients. At the time of database lock (14 July 2023), all patients had discontinued treatment and completed the study. The most common reason for treatment discontinuation was complete surgical resection of the tumor.
Fig. 2
Fig. 2. Waterfall plots showing anti-tumor activity within 12 weeks.
A Best percentage change from baseline in SOD assessed by IRC per mICDs. B Best percentage change from baseline in tumor density assessed by IRC per mICDs. C Best percentage change from baseline in SUVmax assessed by IRC per mEORTC. Patients with at least one on-study target-lesion assessment were included. If any radiological procedure was different and not interchangeable with the procedure at screening, the percentage change from baseline could not be calculated and was not displayed. The dashed line indicates the threshold of partial response for the corresponding criteria. Source data are provided as a Source Data file. IRC Independent Review Committee, SOD sum of the target lesion diameter, CT computed tomography, SUVmax sum of the maximum standardized uptake value, mICDS modified Inverse Choi density/size, mEORTC modified European Organization for Research and Treatment of Cancer.
See this image and copyright information in PMC

References

    1. Mendenhall, W. M., Zlotecki, R. A., Scarborough, M. T., Gibbs, C. P. & Mendenhall, N. P. Giant cell tumor of bone. Am. J. Clin. Oncol.29, 96–99 (2006). - PubMed
    1. Montgomery, C., Couch, C., Emory, C. L. & Nicholas, R. Giant cell tumor of bone: review of current literature, evaluation, and treatment options. J. Knee Surg.32, 331–336 (2019). - PubMed
    1. The WHO Classification of Tumors Editorial Board. WHO Classification of Tumors Soft Tissue and Bone Tumors, 5th Edition edn.(IARC Press, 2020).
    1. Gamberi, G. et al. Identification of markers of possible prognostic value in 57 giant cell tumors of bone. Oncol. Rep.10, 351–356 (2003). - PubMed
    1. Sobti, A., Agrawal, P., Agarwala, S. & Agarwal, M. Giant cell tumor of bone - an overview. Arch. Bone Jt Surg.4, 2–9 (2016). - PMC - PubMed

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