Therapy Detail
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| Therapy Name | Revumenib |
| Synonyms | |
| Therapy Description |
Revuforj (revumenib) 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). Revuforj (revumenib) is FDA-approved for use in adult and pediatric patients 1 year and older with relapsed or refractory acute leukemia harboring KMT2A translocation (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Revumenib | Revuforj | SNDX5613|SNDX 5613|SNDX-5613 | MEN1-KMT2A Inhibitor 8 | Revuforj (revumenib) 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). Revuforj (revumenib) is FDA-approved for use in adult and pediatric patients 1 year and older with relapsed or refractory acute leukemia harboring KMT2A translocation (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| KMT2A rearrange | acute myeloid leukemia | predicted - sensitive | Revumenib | Case Reports/Case Series | Actionable | In a Phase I trial (AUGMENT-101), Revuforj (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 |
| KMT2A rearrange FLT3 exon 14 ins | acute myeloid leukemia | sensitive | Revumenib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Revuforj (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 leukemia | predicted - sensitive | Revumenib | FDA approved | Actionable | In a Phase I trial (AUGMENT 101), Revuforj (revumenib) treatment demonstrated acceptable safety and resulted in a complete remission or complete remission with partial hematologic recovery (CR/CRh) rate of 30% (18/60) and median duration of response of 9.1 mo in adult and pediatric patients 1 year or older with acute leukemia harboring KMT2A rearrangements or NPM1 mutations, with a CR/CRh rate of 33% (15/46) and median time to CR/CRh of 2.0 mo in KMT2A rearranged patients (PMID: 36922593; NCT04065399). | 36922593 detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT05731947 | Phase Ib/II | Revumenib | Evaluation of SNDX-5613 in Participants With Colorectal Cancer and Other Solid Tumors | Recruiting | USA | 0 |
| NCT06229912 | Phase II | Revumenib | A Phase II Study of the Menin Inhibitor Revumenib in Leukemia Associated With Upregulation of HOX Genes | 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 |
| NCT05918913 | Expanded access | Revumenib | Expanded Access Program for SNDX-5613 | Available | USA | 0 |
| NCT04065399 | Phase Ib/II | Revumenib | A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation (AUGMENT-101) | Recruiting | USA | NLD | LTU | ITA | ISR | FRA | ESP | DEU | CAN | AUS | 1 |
| NCT05406817 | Phase I | Revumenib | Study of Radiolabeled SNDX-5613 in Adults With Acute Myeloid Leukemia | 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 Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia | Recruiting | USA | 0 |
| NCT06575296 | Phase I | Revumenib | Revumenib for the Treatment of Acute Leukemia in Patients Post-Allogeneic Stem Cell Transplant | Not yet recruiting | 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 |
| NCT05326516 | Phase I | Revumenib | A Study of Revumenib in Combination With Chemotherapy in Participants With R/R Acute Leukemia | Completed | USA | CAN | 0 |
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