Info
Isatuximab
IsaTUximab
- Design: Phase III randomized trial
- Number of patients: 446
- Patients characteristics: Not specified
- Agent: Isatuximab-VRd group (isatuximab with bortezomib, lenalidomide, and dexamethasone) vs VRd group (bortezomib, lenalidomide, and dexamethasone). Specific doses not provided.
- Treatment line: Not specified
- Trial Acronym IMROZ
賽諾菲安萬特的 IMROZ 第 3 期研究顯示 Sarclisa 與 VRd 聯用，可將新診斷的無法移植多發性骨髓瘤患者的疾病進展或死亡風險降低 40％，這是全球首個用 VRd 聯合抗 CD38 的第 3 期研究，以改善 PFS
- Comparison of efficacy:
| Isatuximab-VRd group | VRd group | |
|---|---|---|
| PFS at 60 months (%) | 63.2% | 45.2% |
| CR or better (%) | 74.7% | 64.1% |
| MRD-negative status and a complete response (%) | 55.5% | 40.9% |
- Highlight of toxicity: No new safety signals observed with the isatuximab-VRd regimen. Incidence of serious adverse events and adverse events leading to discontinuation were similar in both groups.
- One line summary:
- Isatuximab-VRd regimen showed superior efficacy in terms of progression-free survival, complete response rate, and MRD-negative status compared to VRd regimen with similar safety profiles.