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| Molecular Profile | KMT2A rearrange |
| Therapy | Revumenib |
| Indication/Tumor Type | acute leukemia |
| Response Type | sensitive |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| KMT2A rearrange | acute leukemia | sensitive | Revumenib | FDA approved | Actionable | In a Phase I/II trial (AUGMENT 101) that supported FDA approval, Revuforj (revumenib) treatment was well tolerated and resulted in a complete remission (CR) or CR with partial hematologic recovery (CR + CRh) rate of 22.8% (13/57, p=0.0036) and an overall response rate of 63.2% in adult and pediatric patients with relapsed/refractory acute leukemia harboring KMT2A rearrangements (PMID: 39121437; NCT04065399). | 39121437 detail... |
| KMT2A rearrange | acute leukemia | sensitive | Revumenib | Phase I | Actionable | In a Phase I/II trial (AUGMENT 101), Revuforj (revumenib) treatment demonstrated acceptable safety and resulted in a complete remission or complete remission with partial hematologic recovery (CR/CRh) rate of 30% (18/60) and median duration of response of 9.1 mo in adult and pediatric patients 1 year or older with acute leukemia harboring KMT2A rearrangements or NPM1 mutations, with a CR/CRh rate of 33% (15/46) and median time to CR/CRh of 2.0 mo in KMT2A rearranged patients (PMID: 36922593; NCT04065399). | 36922593 |
| PubMed Id | Reference Title | Details |
|---|---|---|
| (36922593) | The menin inhibitor revumenib in KMT2A-rearranged or NPM1-mutant leukaemia. | Full reference... |
| (39121437) | Menin Inhibition With Revumenib for KMT2A-Rearranged Relapsed or Refractory Acute Leukemia (AUGMENT-101). | Full reference... |
| Revuforj (revumenib) FDA Drug Label | Full reference... |