Efficacy and safety of JMT103 in patients with unresectable or surgically-challenging giant cell tumor of bone: a multicenter, phase Ib/II study
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, wi...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Nature Portfolio
2024-11-01
|
| Series: | Nature Communications |
| Online Access: | https://doi.org/10.1038/s41467-024-53686-4 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1846171809644281856 |
|---|---|
| author | 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 Wenxian Zhou Guochuan Zhang Zhaoming Ye Dong Wang Jilong Yang Zhengfu Fan Caigang Liu Guofan Qu Qing Zhang Feng Wei Weifeng Liu Chongqi Tu Hong Li Jing Yuan Xiaohui Niu |
| author_facet | 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 Wenxian Zhou Guochuan Zhang Zhaoming Ye Dong Wang Jilong Yang Zhengfu Fan Caigang Liu Guofan Qu Qing Zhang Feng Wei Weifeng Liu Chongqi Tu Hong Li Jing Yuan Xiaohui Niu |
| author_sort | Hairong Xu |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-55d90559901a45d7b87e4d04f7225e5a |
| institution | Kabale University |
| issn | 2041-1723 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Nature Communications |
| spelling | doaj-art-55d90559901a45d7b87e4d04f7225e5a2024-11-10T12:33:45ZengNature PortfolioNature Communications2041-17232024-11-011511910.1038/s41467-024-53686-4Efficacy and safety of JMT103 in patients with unresectable or surgically-challenging giant cell tumor of bone: a multicenter, phase Ib/II studyHairong Xu0Yong Zhou1Li Liang2Jingnan Shen3Wangjun Yan4Jin Wang5Jianmin Li6Xiaojing Zhang7Gang Huang8Wenzhi Bi9Zheng Guo10Yanbin Xiao11Jianhua Lin12Weitao Yao13Zhichao Tong14Wenxian Zhou15Guochuan Zhang16Zhaoming Ye17Dong Wang18Jilong Yang19Zhengfu Fan20Caigang Liu21Guofan Qu22Qing Zhang23Feng Wei24Weifeng Liu25Chongqi Tu26Hong Li27Jing Yuan28Xiaohui Niu29Department of Orthopedic Oncology Surgery, Beijing Jishuitan Hospital, Capital Medical UniversityDepartment of Orthopedics, West China Hospital, Sichuan UniversityDepartment of Medical Oncology and Radiation Sickness, Peking University Third HospitalDepartment of Musculoskeletal Oncology, The First Affiliated Hospital of Sun Yat-Sen UniversityDepartment of Musculoskeletal Oncology, Fudan University Shanghai Cancer CenterDepartment of Musculoskeletal Oncology, Sun Yat-Sen University Cancer CenterDepartment of Orthopedic Oncology, Qilu Hospital of Shandong UniversityDepartment of Bone and Soft Tissue Surgery, Liaoning Cancer Hospital and InstituteDepartment of Bone and Soft Tissue Surgery, Hunan Cancer HospitalSenior Department of Orthopedics, The Fourth Medical Center, Chinese PLA General HospitalDepartment of Orthopedics, The Second Affiliated Hospital of Air Force Medical UniversityThe Second Department of Orthopedic Surgery, Yunnan Cancer HospitalDepartment of Orthopedics, The First Affiliated Hospital of Fujian Medical UniversityDepartment of Bone and Soft Tissue, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer HospitalDepartment of Bone Tumor, Honghui Hospital, Xi’an Jiaotong UniversityDepartment of Breast, Bone and Soft Tissue Oncology, Guangxi Medical University Cancer HospitalDepartment of Bone and Soft Tissue Tumor, The Third Hospital of Hebei Medical UniversityDepartment of Orthopedics, The Second Affiliated Hospital of Zhejiang University School of MedicineDepartment of Orthopedics, Affiliated Cancer Hospital of Guizhou Medical UniversityDepartment of Bone and Soft Tissue Tumor, Tianjin Medical University Cancer Institute & HospitalDepartment of Bone and Soft Tissue Tumor, Peking University Cancer HospitalDepartment of Oncology, Shengjing Hospital of China Medical UniversityDepartment of Orthopedic Surgery, Harbin Medical University Cancer HospitalDepartment of Orthopedic Oncology Surgery, Beijing Jishuitan Hospital, Capital Medical UniversityDepartment of Medical Oncology and Radiation Sickness, Peking University Third HospitalDepartment of Orthopedic Oncology Surgery, Beijing Jishuitan Hospital, Capital Medical UniversityDepartment of Orthopedics, West China Hospital, Sichuan UniversityCSPC Pharmaceutical Group LimitedCSPC Pharmaceutical Group LimitedDepartment of Orthopedic Oncology Surgery, Beijing Jishuitan Hospital, Capital Medical UniversityAbstract 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.https://doi.org/10.1038/s41467-024-53686-4 |
| spellingShingle | 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 Wenxian Zhou Guochuan Zhang Zhaoming Ye Dong Wang Jilong Yang Zhengfu Fan Caigang Liu Guofan Qu Qing Zhang Feng Wei Weifeng Liu Chongqi Tu Hong Li Jing Yuan Xiaohui Niu 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 |
| title | Efficacy and safety of JMT103 in patients with unresectable or surgically-challenging giant cell tumor of bone: a multicenter, phase Ib/II study |
| title_full | Efficacy and safety of JMT103 in patients with unresectable or surgically-challenging giant cell tumor of bone: a multicenter, phase Ib/II study |
| title_fullStr | Efficacy and safety of JMT103 in patients with unresectable or surgically-challenging giant cell tumor of bone: a multicenter, phase Ib/II study |
| title_full_unstemmed | Efficacy and safety of JMT103 in patients with unresectable or surgically-challenging giant cell tumor of bone: a multicenter, phase Ib/II study |
| title_short | Efficacy and safety of JMT103 in patients with unresectable or surgically-challenging giant cell tumor of bone: a multicenter, phase Ib/II study |
| title_sort | efficacy and safety of jmt103 in patients with unresectable or surgically challenging giant cell tumor of bone a multicenter phase ib ii study |
| url | https://doi.org/10.1038/s41467-024-53686-4 |
| work_keys_str_mv | AT hairongxu efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT yongzhou efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT liliang efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT jingnanshen efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT wangjunyan efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT jinwang efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT jianminli efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT xiaojingzhang efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT ganghuang efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT wenzhibi efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT zhengguo efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT yanbinxiao efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT jianhualin efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT weitaoyao efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT zhichaotong efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT wenxianzhou efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT guochuanzhang efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT zhaomingye efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT dongwang efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT jilongyang efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT zhengfufan efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT caigangliu efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT guofanqu efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT qingzhang efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT fengwei efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT weifengliu efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT chongqitu efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT hongli efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT jingyuan efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy AT xiaohuiniu efficacyandsafetyofjmt103inpatientswithunresectableorsurgicallychallenginggiantcelltumorofboneamulticenterphaseibiistudy |