olutasidenib + nivolumab

Olutasidenib + nivolumab is an **investigational combination therapy** composed of olutasidenib, a selective oral inhibitor of mutant isocitrate dehydrogenase 1 (IDH1), and nivolumab, a programmed death-1 (PD-1) checkpoint inhibitor monoclonal antibody. Olutasidenib is approved as monotherapy for relapsed or refractory IDH1-mutated acute myeloid leukemia (AML), blocking the neomorphic IDH1 enzymatic activity to decrease oncometabolite 2-HG and restore differentiation potential in IDH1-mutant cells. Nivolumab, which is widely approved for several tumor types, acts as an immune checkpoint inhibitor that reactivates T-cell immune response against cancer cells by blocking PD-1 on lymphocytes. As a combination, the regimen aims to target mutant metabolic and immune evasion pathways for synergistic antitumor activity, though as of 2025, **no clinical evidence** or published clinical trials substantiate the safety, efficacy, or use of this specific doublet in any disease setting, including AML or solid tumors[1][2][3][5].