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**Decitabine + spartalizumab** is a fixed-dose combination regimen used primarily in early-phase clinical trials for hematological malignancies, notably acute myeloid leukemia (AML) and high/very high-risk myelodysplastic syndrome (MDS). **Decitabine** is a DNA hypomethylating agent, classified as a cytidine deoxynucleoside analogue, that inhibits DNA methyltransferases and induces gene promoter hypomethylation, leading to the reactivation of silenced genes involved in differentiation and apoptosis of malignant cells. **Spartalizumab** is a humanized monoclonal antibody targeted against PD-1 (programmed cell death protein 1), acting as a checkpoint inhibitor and enhancing T-cell–mediated anti-tumor immune responses. The combination is given intravenously, with decitabine administered over 5 days followed by spartalizumab infusion, as investigated in phase 1b clinical studies for AML and MDS. Novartis is the primary developer and manufacturer of spartalizumab, and was the sponsor for the relevant clinical trial. Decitabine is developed and marketed by several manufacturers, with Eisai as a key developer.
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