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JMT103 versus Non-Denosumab or Denosumab Treatment in Chinese Patients with Unresectable or Surgically Challenging
Hairong Xu1, Yong Zhou2, Feng Wei3
1Department of Orthopedic Oncology Surgery, Beijing Jishuitan Hospital, Capital Medical University, Beijing, China.
Background:
Giant cell tumors of bone (GCTB) are RANK/RANK-ligand positive, progressive osteolytic tumors. There was no medical treatment for GCTB based on efficacy and safety data from Chinese patients. A single-arm, phase II study demonstrated the promising efficacy of JMT103 in unresectable or surgically challenging GCTB. Patient-level outcomes from the single-arm trial were compared with real-world data from denosumab or non-denosumab treated patients to estimate comparative efficacy in unresectable or surgically challenging GCTB.
Methods:
The real-world data were retrospectively collected from three hospitals between January 2013 and December 2023. The eligibility criteria of the two cohorts were based on the JMT103 single-arm study. Propensity score matching was used to balance the baseline characteristics of patients in the JMT103 and the real-world cohorts. The primary endpoint was histopathological or 12 week radiological objective tumor response rate (OTR). Secondary endpoints included tumor response rate throughout the study, objective response rate, disease control rate, and safety profiles.
Results:
166 and 135 patients were finally included in the non-denosumab and denosumab cohorts, respectively. After 1:1 nearest neighbor matching, the OTR of the JMT103 cohort was significantly higher than that of the non-denosumab cohort (94.2% vs. 4.8%), and was comparable with that of the denosumab cohort (92.0% vs. 67.0%). The same results were observed in tumor response rate throughout the study (JMT103 vs. non-denosumab: 94.2% vs. 4.8%, JMT103 vs. denosumab: 94.3% vs. 86.4%), objective response rate (83.5% vs. 11.1%, 87.4% vs. 80.0%), and disease control rate (100% vs. 70.4%, 100.0% vs. 98.8%).
Conclusion:
JMT103 has manageable safety profiles with better effectiveness than non-denosumab and a trend toward greater effectiveness than denosumab in patients with unresectable or surgically challenging GCTB.
Trial Registration:
NCT05402865, NCT04255576.
Insights
A new drug, JMT103, shows superior effectiveness compared to non-denosumab and comparable effectiveness to denosumab for treating giant cell tumors of bone (GCTB). This study provides crucial data for unresectable or surgically challenging GCTB cases.
Area of Science:
- Oncology
- Orthopedic Surgery
- Pharmacology
Background:
- Giant cell tumors of bone (GCTB) are aggressive osteolytic bone tumors.
- Current treatments lack robust efficacy and safety data for Chinese patients.
- JMT103 shows promise in a phase II study for unresectable or challenging GCTB.
Purpose of the Study:
- To compare the efficacy of JMT103 against real-world data of denosumab and non-denosumab treatments.
- To evaluate JMT103 in patients with unresectable or surgically challenging GCTB.
- To assess the safety and effectiveness of JMT103 in a comparative real-world setting.
Main Methods:
- Retrospective collection of real-world data from January 2013 to December 2023.
- Propensity score matching to balance baseline characteristics between JMT103 and real-world cohorts.
- Primary endpoint: 12-week objective tumor response rate (OTR); Secondary endpoints: overall response rate, disease control rate, and safety.
Main Results:
- JMT103 demonstrated a significantly higher OTR (94.2%) versus non-denosumab (4.8%) and comparable OTR (92.0%) versus denosumab (67.0%).
- Similar trends observed for overall response rate and disease control rate, favoring JMT103.
- JMT103 exhibited manageable safety profiles across all evaluated metrics.
Conclusions:
- JMT103 offers superior effectiveness compared to non-denosumab for GCTB.
- JMT103 shows a trend towards greater effectiveness than denosumab.
- JMT103 presents a viable treatment option with manageable safety for challenging GCTB cases.
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