Drug intelligence / Profile preview

revumenib + venetoclax + azacitidine

Development stage
Phase 3
Lead developer
AbbVie
Modality
Small Molecules
Administration
Intravenous, Oral, Subcutaneous
01

Overview

**revumenib + venetoclax + azacitidine** (marketed as **Revuforj + Venclexta + Vidaza**) is an investigational triplet combination regimen being evaluated for the treatment of newly diagnosed acute myeloid leukemia (AML) harboring nucleophosmin 1 (NPM1) mutations or lysine methyltransferase 2A (KMT2A) rearrangements, particularly in patients who are older or unfit for intensive chemotherapy. The regimen combines three distinct therapeutic mechanisms: revumenib (Revuforj), an oral small molecule menin-KMT2A inhibitor developed by Syndax; venetoclax (Venclexta), an oral BCL-2 inhibitor developed by AbbVie and Genentech; and azacitidine (Vidaza), a hypomethylating agent developed by Bristol Myers Squibb. By simultaneously targeting the menin-KMT2A interaction (which drives leukemogenic transcription), inhibiting BCL-2 (to promote apoptosis in leukemia stem cells), and inducing DNA hypomethylation, the triplet regimen aims to overcome resistance and achieve deep, durable remissions. The combination is currently being evaluated in the pivotal Phase 3 EVOLVE-2 trial (NCT06652438) and has demonstrated high rates of complete remission and minimal residual disease (MRD) negativity in clinical studies.

Other names
Revuforj + Venclexta + VidazaRevuforj + venetoclax + azacitidineSNDX-5613 + venetoclax + azacitidinerevumenib + azacitidine + venetoclaxrevumenib + venetoclax + azacitidinerevumenib + venetoclax/azacitidinerevumenib plus azacitidine/venetoclaxrevumenib plus venetoclax/azacitidinerevumenib, azacitidine, and venetoclax
02

Targets

Bcl-w (B-cell lymphoma 2-like 2)BCL2L1 (B-cell lymphoma-extra large protein)DNMT1 (DNA (cytosine-5)-methyltransferase 1)MEN1 (Menin)BCL-2 (BCL-2 family)DNMT3A (DNA methyltransferase 3 alpha)DNMT3B (DNA (cytosine-5)-methyltransferase 3B)

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