Drug intelligence / Profile preview

palbociclib + sasanlimab

Development stage
Phase 2
Lead developer
Pfizer
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Oral, Subcutaneous
01

Overview

palbociclib + sasanlimab is an investigational combination therapy consisting of a CDK4/6 inhibitor and a PD-1 checkpoint inhibitor. Palbociclib (marketed as Ibrance) is a selective, small-molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6), which are critical regulators of the cell cycle; by inhibiting these kinases, it prevents the phosphorylation of the retinoblastoma (Rb) protein and blocks cell cycle progression from the G1 to the S phase. Sasanlimab is a humanized monoclonal antibody that acts as a programmed cell death protein 1 (PD-1) inhibitor, preventing PD-1 from binding to its ligands (PD-L1 and PD-L2) and thereby restoring T-cell mediated anti-tumor immune responses. This combination is being evaluated in a Phase I/II clinical trial (NCT05665361) sponsored by the National Cancer Institute (NCI) for the treatment of advanced renal cell carcinoma subtypes, specifically clear cell (ccRCC) and papillary (pRCC), to determine if the dual inhibition of cell cycle progression and immune checkpoints provides synergistic efficacy.

Other names
palbociclibsasanlimab
02

Targets

CDK4 (Cyclin-dependent kinase 4)CDK6 (Cyclin-dependent kinase 6)PDCD1 (Programmed cell death protein 1 receptor)

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