NOTE
🌱 created from: gilteritinib
Gilteritinib or Chemotherapy For Relapsed Or Refractory FLT3-Mutated AML
Information
- Design: Phase 3, randomized, controlled, multi-center
- Number of patients: 371
- Patients characteristics: Adults with relapsed or refractory FLT3-mutated acute myeloid leukemia (AML)
- Agent: Gilteritinib (120 mg per day) vs salvage chemotherapy
- Treatment line: Salvage therapy
- Trial Name or NCT Number: ADMIRAL (NCT02421939)
Comparison of two groups
| Endpoint | Gilteritinib | Salvage Chemotherapy |
|---|---|---|
| Median Overall Survival | 9.3 months | 5.6 months |
| Hazard Ratio for Death | 0.64 (0.49-0.83) | - |
| Median Event-Free Survival | 2.8 months | 0.7 months |
| Hazard Ratio for Treatment Failure or Death | 0.79 (0.58-1.09) | - |
| Complete Remission with Full or Partial Hematologic Recovery | 34.0% | 15.3% |
| Complete Remission | 21.1% | 10.5% |
Other findings
- Adverse events of grade 3 or higher and serious adverse events occurred less frequently in the gilteritinib group than in the chemotherapy group
- The most common adverse events of grade 3 or higher in the gilteritinib group were febrile neutropenia (45.9%), anemia (40.7%), and thrombocytopenia (22.8%)
Summary In this phase 3 trial, gilteritinib, an oral, potent, selective FLT3 inhibitor, showed significant improvement in overall survival, event-free survival, and remission rates compared to salvage chemotherapy in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia. Gilteritinib was also associated with fewer adverse events than chemotherapy.