Drug intelligence / Profile preview

casdatifan + ipilimumab + nivolumab

Development stage
Unknown
Lead developer
Arcus Biosciences
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Intravenous, Oral
01

Overview

Casdatifan + ipilimumab + nivolumab is an investigational triplet combination regimen being developed for the first-line treatment of advanced clear cell renal cell carcinoma (ccRCC). The regimen combines casdatifan (AB521), an oral small-molecule inhibitor of hypoxia-inducible factor 2-alpha (HIF-2α) developed by Arcus Biosciences, with the approved standard-of-care dual immunotherapy backbone of ipilimumab (Yervoy), an anti-CTLA-4 monoclonal antibody, and nivolumab (Opdivo), an anti-PD-1 monoclonal antibody, both developed by Bristol Myers Squibb. By combining HIF-2α inhibition with dual immune checkpoint blockade, the regimen aims to simultaneously target tumor survival pathways and enhance anti-tumor immune responses. The triplet is being evaluated in the Phase 3 PEAK-20 trial, which randomizes previously untreated advanced ccRCC patients to receive either the triplet combination or nivolumab plus ipilimumab alone.

Other names
AB521 + ipilimumab + nivolumabAB521 + nivolumab + ipilimumabAB521 plus ipilimumab plus nivolumabAB-521 plus ipilimumab plus nivolumabAB 521 plus ipilimumab plus nivolumabcasdatifan + nivolumab + ipilimumabcasdatifan plus ipilimumab plus nivolumab
02

Targets

CD80 (T-lymphocyte activation antigen CD80)CD86 (T-lymphocyte activation antigen CD86)CTLA-4 (Cytotoxic t-lymphocyte–associated protein 4)ARNT (Aryl hydrocarbon receptor nuclear translocator)EPAS1 (Hypoxia-inducible factor 2-alpha)PDCD1 (Programmed cell death protein 1 receptor)CD274 (Programmed cell death protein 1 ligand 1)PDCD1LG2 (Programmed cell death 1 ligand 2)

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