Therapy Detail

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Therapy Name Revumenib
Synonyms
Therapy Description

Revumenib (SNDX-5613) inhibits the interaction between Menin and KMT2A (MLL), potentially resulting in antitumor activity and decreased proliferation of tumor cells with KMT2A (MLL) rearrangements or NPM1 mutations (PMID: 36922593, PMID: 36922589).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Revumenib SNDX5613|SNDX 5613|SNDX-5613 MEN1-KMT2A Inhibitor 7 Revumenib (SNDX-5613) inhibits the interaction between Menin and KMT2A (MLL), potentially resulting in antitumor activity and decreased proliferation of tumor cells with KMT2A (MLL) rearrangements or NPM1 mutations (PMID: 36922593, PMID: 36922589).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
KMT2A rearrange acute leukemia predicted - sensitive Revumenib Phase I Actionable In a Phase I trial (AUGMENT 101), Revumenib treatment demonstrated acceptable safety and promising antileukemic activity in patients with acute leukemia harboring KMT2A rearrangements, and led to a composite complete response rate of 49% (17/35) (Blood (2021) 138 (Supplement 1): 699). detail...
KMT2A rearrange FLT3 exon 14 ins acute myeloid leukemia sensitive Revumenib Preclinical - Cell line xenograft Actionable In a preclinical study, Revumenib reduced the leukemia burden and improved survival in an acute myeloid leukemia cell line xenograft model harboring a KMT2A rearrangement (MLL-r) and FLT3-ITD compared to vehicle-treated, but only inhibited cell viability after prolonged treatment in culture (PMID: 35017466). 35017466
KMT2A rearrange acute myeloid leukemia predicted - sensitive Revumenib Case Reports/Case Series Actionable In a Phase I trial (AUGMENT-101), Revumenib treatment resulted in an initial response with morphological leukemia-free states in 2 patients with acute myeloid leukemia harboring KMT2A rearrangements (PMID: 36922589; NCT04065399). 36922589

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT05326516 Phase I Revumenib A Study of SNDX-5613 in Combination With Chemotherapy in Participants With R/R Acute Leukemia Active, not recruiting USA | CAN 0
NCT06229912 Phase II Revumenib A Phase II Study of the Menin Inhibitor Revumenib in Leukemia Associated With Upregulation of HOX Genes Not yet recruiting USA 0
NCT05406817 Phase I Revumenib Study of Radiolabeled SNDX-5613 in Adults With Acute Myeloid Leukemia Recruiting USA 0
NCT05360160 Phase Ib/II Decitabine and Cedazuridine Revumenib Venetoclax A Phase I-II Study Investigating the All Oral Combination of the Menin Inhibitor SNDX-5613 With Decitabine/Cedazuridine (ASTX727) and Venetoclax in Acute Myeloid Leukemia (SAVE) Recruiting USA 0
NCT05761171 Phase II Cytarabine + Fludarabine Pegaspargase + Prednisone + Vincristine Sulfate Calaspargase pegol-mknl + Prednisone + Vincristine Sulfate Revumenib Cytarabine + Hydrocortisone + Methotrexate Pegaspargase + Prednisolone + Vincristine Sulfate Calaspargase pegol-mknl + Prednisolone + Vincristine Sulfate A Study of SNDX-5613 in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia Recruiting USA 0
NCT05918913 Expanded access Revumenib Expanded Access Program for SNDX-5613 Available USA 0
NCT06226571 Phase I Cytarabine + Idarubicin + Revumenib Revumenib Cytarabine + Daunorubicin + Revumenib Cytarabine A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias Recruiting USA 0
NCT05731947 Phase Ib/II Revumenib Evaluation of SNDX-5613 in Participants With Colorectal Cancer and Other Solid Tumors Recruiting USA 0
NCT04065399 Phase Ib/II Revumenib A Study of SNDX-5613 in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation (AUGMENT-101) Recruiting USA | NLD | ITA | FRA | ESP | DEU | CAN | AUS 2


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