Drug intelligence / Profile preview

rogaratinib + atezolizumab

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

Overview

**Rogaratinib + atezolizumab** is an investigational combination therapy for locally advanced or metastatic urothelial carcinoma (UC), specifically in cisplatin-ineligible patients whose tumors overexpress FGFR1/3 mRNA. Rogaratinib is an orally administered, selective, pan-fibroblast growth factor receptor (FGFR) inhibitor. Atezolizumab is a monoclonal antibody targeting programmed cell death ligand 1 (PD-L1), functioning as an immune checkpoint inhibitor. This combination is designed to overcome tumor resistance observed in FGFR-overexpressing UC and broaden the population benefiting from immunotherapy. The recommended phase 2 dose is rogaratinib 600 mg twice daily plus intravenous atezolizumab 1200 mg every 21 days. In phase 1b clinical studies (FORT-2), this regimen demonstrated manageable safety and promising efficacy, with objective responses independent of PD-L1 status or FGFR3 genetic alterations.

Other names
rogaratinib + atezolizumabFORT-2 regimenFORT2 regimenFORT 2 regimen
02

Targets

FGFR4 (Fibroblast growth factor receptor 4)CSF1R (Macrophage colony-stimulating factor receptor)FGFR3 (Fibroblast growth factor receptor 3)VEGFR-1 (Vascular endothelial growth factor receptor 1)CD274 (Programmed cell death protein 1 ligand 1)VEGFR3 (Vascular endothelial growth factor receptor 3)FGFR2 (Keratinocyte growth factor receptor)FGFR1 (Fibroblast growth factor receptor 1)

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