New Protocol: Revumenib, Decitabine, and Venetoclax for Rel/Ref AML

This phase I-II study evaluated an all-oral combination of revumenib, decitabine/cedazuridine, and venetoclax in patients with relapsed or refractory acute myeloid leukemia. The regimen demonstrated high response rates, with a composite complete remission rate of 71% and an overall response rate of 88%. The treatment was associated with an acceptable safety profile, and remissions were durable, especially in patients achieving undetectable measurable residual disease.

Study

Phase I-II, single-center, open-label study [SAVE; NCT05360160]

KMT2A-rearranged, NPM1-mutated, or NUP98-rearranged relapsed/refractory AML

Revumenib + Decitabine/Cedazuridine + Venetoclax (n=42)

Efficacy

ORR: 88% [78.3-97.9]

CRc: 71%

CR/CRh: 60%

mDOR (CR/CRh): 10.5 mos

1-yr OS: 56%

Safety

Grade >=3 AE: febrile neutropenia (36%), lung infection (21%), thrombocytopenia (21%), increased AST/ALT (21%), respiratory failure (14%), sinusitis (12%), sepsis (10%), neutropenia (10%), hypokalemia (7%), increased bilirubin (7%), acute kidney injury (7%), skin infection (7%), QT prolongation (5%), pleural effusion (5%), differentiation syndrome (5%)

Early (60-day) mortality: 2%