A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Revumenib in Combination with Intensive Chemotherapy in Participants with Newly Diagnosed AML with an NPM1 mutation (REVEAL-ND NPM1)

Trial status: Authorised OS: Defined as the time from the date of randomization to the date of death from any cause., EFS (Investigator-assessed): Defined as the time from the date of randomization to the date of Induction treatment failure, relapse or death due to any cause, whichever occurs first., MRDBM (-) CR rate: Defined as the percentage of participants with CR (Investigator-assessed) who achieve MRDBM (-) status by molecular assay, MRDPB (-) CR rate: Defined as the percent of participants with CR (Investigator assessed) who achieve MRDPB (-) status by molecular assay, MRDBM (-) CR rate: Defined as the percent of participants with CR who achieve MRDBM (-) status., CR rate (Investigator-assessed): Defined as the percentage of participants who achieve CR, CRc rate (Investigator-assessed): Defined as the rate of CR + CRh (complete remission with partial hematologic recovery) + Cri (complete remission with incomplete hematologic recovery)., ORR (Investigator-assessed): Defined as the rate of CR + CRh + CRi + MLFS (morphologic leukemia-free state) + PR (partial response)., Duration of CR: Defined as time from first date of first CR to relapse or death., Duration of CRc: Defined as time from first date of first CRc to relapse or death., DOR: Defined as time from date of first documented response (CR, CRh, CRi, PR, or MLFS) to the first documented relapse or death., • Frequency, duration, and severity of TEAEs (treatment-emergent adverse events), TRAEs (treatment-related adverse event), and SAEs. • Incidence and shifts from baseline of clinically significant clinical laboratory abnormalities. • Change from baseline in other observations related to safety, including ECGs, vital signs, and performance status. EFS: Defined as the time from the date of randomization to the date of Induction treatment failure, relapse or death due to any cause, whichever occurs first. MRDBM (-) CR rate: Defined as the percentage of participants with CR

OS: Defined as the time from the date of randomization to the date of death from any cause., EFS (Investigator-assessed): Defined as the time from the date of randomization to the date of Induction treatment failure, relapse or death due to any cause, whichever occurs first., MRDBM (-) CR rate: Defined as the percentage of participants with CR (Investigator-assessed) who achieve MRDBM (-) status by molecular assay, MRDPB (-) CR rate: Defined as the percent of participants with CR (Investigator assessed) who achieve MRDPB (-) status by molecular assay, MRDBM (-) CR rate: Defined as the percent of participants with CR who achieve MRDBM (-) status., CR rate (Investigator-assessed): Defined as the percentage of participants who achieve CR, CRc rate (Investigator-assessed): Defined as the rate of CR + CRh (complete remission with partial hematologic recovery) + Cri (complete remission with incomplete hematologic recovery)., ORR (Investigator-assessed): Defined as the rate of CR + CRh + CRi + MLFS (morphologic leukemia-free state) + PR (partial response)., Duration of CR: Defined as time from first date of first CR to relapse or death., Duration of CRc: Defined as time from first date of first CRc to relapse or death., DOR: Defined as time from date of first documented response (CR, CRh, CRi, PR, or MLFS) to the first documented relapse or death., • Frequency, duration, and severity of TEAEs (treatment-emergent adverse events), TRAEs (treatment-related adverse event), and SAEs. • Incidence and shifts from baseline of clinically significant clinical laboratory abnormalities. • Change from baseline in other observations related to safety, including ECGs, vital signs, and performance status.

Age group: 0-17 years, 65+ years, 18-64 years Gender: Female, Male Target enrollment: 329 participants