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Abemaciclib + irinotecan + temozolomide + dinutuximab + granulocyte-macrophage colony-stimulating factor is an investigational multi-agent combination therapy being evaluated for the treatment of relapsed or refractory high-risk neuroblastoma. The regimen adds abemaciclib, a selective small-molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6), to the established chemoimmunotherapy backbone of irinotecan and temozolomide (chemotherapy), dinutuximab (a chimeric monoclonal antibody targeting the GD2 disialoganglioside), and GM-CSF (a cytokine used to stimulate immune effector cells). This combination is currently being studied in the Phase 1b/2 JPCS trial (NCT04238819) to determine if the addition of cell cycle inhibition can improve clinical outcomes in pediatric and young adult patients who have failed prior therapies.
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