The AUGMENT-101 study showed that revumenib led to high response rates in relapsed or refractory KMT2A-rearranged acute leukemia. Patients had an overall response rate of 63.2% with a complete remission rate of 22.8% and median overall survival of 8.0 months. The treatment was associated with a favorable safety profile, although grade 3 adverse events occurred in 91.5% of patients.
Study
|
Phase I/II, open-label, dose-escalation and expansion study [AUGMENT-101] |
| Relapsed/refractory KMT2A-rearranged acute leukemia |
| Revumenib every 12 hours (n=94)
|
Efficacy
|
ORR: 63.2% [49.3-75.6] |
| CR/CRh: 22.8% [12.7-35.8] |
| mOS: 8.0 mos [4.1-10.9]
|
Safety
|
Grade >=3 AE: febrile neutropenia (37.2%), differentiation syndrome (16.0%), QTc prolongation (13.8%), sepsis (11.7%) |
| Drug discontinuation due to AE: 12.8% |
| Deaths: 14.9%
|
J Clin Oncol 2024;43:75-84
Issa GC, Aldoss I, Thirman MJ New Reference: Revumenib for Rel/Ref KMT2A-Rearranged AML
http://doi.org/10.1200/JCO.24.00826
Reviewed by Ulas D. Bayraktar, MD on Nov 6, 2025
