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abemaciclib + irinotecan + temozolomide + dinutuximab + granulocyte-macrophage colony-stimulating factor

Development stage
Unknown
Lead developer
Eli Lilly
Modality
Small Molecules, Monoclonal Antibodies → Antibody-Based Therapeutics, Cytokines & Interferons → Recombinant Proteins and Enzymes
Administration
Oral, Intravenous, Subcutaneous
01

Overview

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.

Other names
abemaciclib + irinotecan + temozolomide + dinutuximab + sargramostimI/T/DIN/GM-CSF + abemaciclibJPCS Part C regimen
02

Targets

CSF2R (Granulocyte-macrophage colony-stimulating factor receptor)GD2N7-G (DNA guanine-N7 adduct)CDK6 (Cyclin-dependent kinase 6)TOP1 (DNA Topoisomerase I)CDK4 (Cyclin-dependent kinase 4)

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