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

Autor: Xu H; Department of Orthopedic Oncology Surgery, Beijing Jishuitan Hospital, Capital Medical University, Beijing, China., Zhou Y; Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, China., Liang L; Department of Medical Oncology and Radiation Sickness, Peking University Third Hospital, Beijing, China., Shen J; Department of Musculoskeletal Oncology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China., Yan W; Department of Musculoskeletal Oncology, Fudan University Shanghai Cancer Center, Shanghai, China., Wang J; Department of Musculoskeletal Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China., Li J; Department of Orthopedic Oncology, Qilu Hospital of Shandong University, Jinan, China., Zhang X; Department of Bone and Soft Tissue Surgery, Liaoning Cancer Hospital and Institute, Shenyang, China., Huang G; Department of Bone and Soft Tissue Surgery, Hunan Cancer Hospital, Changsha, China., Bi W; Senior Department of Orthopedics, The Fourth Medical Center, Chinese PLA General Hospital, Beijing, China., Guo Z; Department of Orthopedics, The Second Affiliated Hospital of Air Force Medical University, Xi'an, China., Xiao Y; The Second Department of Orthopedic Surgery, Yunnan Cancer Hospital, Kunming, China., Lin J; Department of Orthopedics, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China., Yao W; Department of Bone and Soft Tissue, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China., Tong Z; Department of Bone Tumor, Honghui Hospital, Xi'an Jiaotong University, Xi'an, China., Zhou W; Department of Breast, Bone and Soft Tissue Oncology, Guangxi Medical University Cancer Hospital, Nanning, China., Zhang G; Department of Bone and Soft Tissue Tumor, The Third Hospital of Hebei Medical University, Shijiazhuang, China., Ye Z; Department of Orthopedics, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China., Wang D; Department of Orthopedics, Affiliated Cancer Hospital of Guizhou Medical University, Guiyang, China., Yang J; Department of Bone and Soft Tissue Tumor, Tianjin Medical University Cancer Institute & Hospital, Tianjin, China., Fan Z; Department of Bone and Soft Tissue Tumor, Peking University Cancer Hospital, Beijing, China., Liu C; Department of Oncology, Shengjing Hospital of China Medical University, Shenyang, China., Qu G; Department of Orthopedic Surgery, Harbin Medical University Cancer Hospital, Harbin, China., Zhang Q; Department of Orthopedic Oncology Surgery, Beijing Jishuitan Hospital, Capital Medical University, Beijing, China., Wei F; Department of Medical Oncology and Radiation Sickness, Peking University Third Hospital, Beijing, China.; Department of Orthopedics, Peking University Third Hospital, Beijing, China., Liu W; Department of Orthopedic Oncology Surgery, Beijing Jishuitan Hospital, Capital Medical University, Beijing, China., Tu C; Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, China., Li H; CSPC Pharmaceutical Group Limited, Shijiazhuang, China., Yuan J; CSPC Pharmaceutical Group Limited, Shijiazhuang, China., Niu X; Department of Orthopedic Oncology Surgery, Beijing Jishuitan Hospital, Capital Medical University, Beijing, China. niuxiaohui@263.net.
Jazyk: angličtina
Zdroj: Nature communications [Nat Commun] 2024 Nov 05; Vol. 15 (1), pp. 9541. Date of Electronic Publication: 2024 Nov 05.
DOI: 10.1038/s41467-024-53686-4
Abstrakt: 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.
(© 2024. The Author(s).)
Databáze: MEDLINE
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