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BMS-986365
BMS-986365 is a selective inhibitor of menin that disrupts the interaction between menin and mixed-lineage leukemia (MLL) proteins, restoring normal gene expression in leukemic cells.
BMS-986365 is a selective inhibitor of menin that disrupts the interaction between menin and mixed-lineage leukemia (MLL) proteins, restoring normal gene expression in leukemic cells. Used for Acute myeloid leukemia (AML) with NPM1 mutation or MLL rearrangement, Mixed-lineage leukemia (MLL)-rearranged acute leukemia.
At a glance
| Generic name | BMS-986365 |
|---|---|
| Also known as | AR-LDD, CC-94676, CC-94676 |
| Sponsor | Celgene |
| Drug class | Menin inhibitor |
| Target | Menin (MEN1) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
The drug works by blocking the menin-MLL protein-protein interaction, which is critical for the survival of MLL-rearranged leukemias and other hematologic malignancies. By disrupting this interaction, BMS-986365 allows normal differentiation and apoptosis of leukemic cells. This mechanism is particularly relevant in acute leukemias driven by MLL translocations or NPM1 mutations.
Approved indications
- Acute myeloid leukemia (AML) with NPM1 mutation or MLL rearrangement
- Mixed-lineage leukemia (MLL)-rearranged acute leukemia
Common side effects
- Differentiation syndrome
- Cytopenias
- Nausea
- Diarrhea
- Fatigue
Key clinical trials
- A Study of BMS986365 in Combination With Degarelix in People With Prostate Cancer (PHASE2)
- A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer (PHASE3)
- A Study to Evaluate the Effect of Itraconazole and Rifampin on the Drug Levels of AR-LDD (BMS-986365) in Healthy Adult Male Participants (PHASE1)
- Study to Evaluate the Safety and Tolerability of CC-94676 in Participants With Metastatic Castration-Resistant Prostate Cancer (PHASE1)
- A Study to Evaluate the Drug Levels, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants (PHASE1)
- Study to Evaluate Safety, Drug Levels, Food and Relative Bioavailability of BMS-986365 in Healthy Adult Male Participants (PHASE1)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |