Drug intelligence / Profile preview

tivozanib + nivolumab

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

Overview

Tivozanib + nivolumab is a **combination therapy** composed of tivozanib—a potent, selective inhibitor of vascular endothelial growth factor receptors (VEGFR)—and nivolumab, a monoclonal antibody targeting programmed cell death protein 1 (PD-1). Tivozanib acts as a tyrosine kinase inhibitor, blocking VEGFR signaling and thereby inhibiting angiogenesis and reducing regulatory T cells, which may enhance antitumor immune responses. Nivolumab is an immune checkpoint inhibitor that prevents PD-1 engagement by its ligands, restoring antitumor T cell activity. This combination aims for synergistic antitumor effects by simultaneously inhibiting tumor angiogenesis and reversing immune suppression. It has been primarily developed and studied for metastatic renal cell carcinoma (RCC), including both treatment-naïve and previously treated populations[1][2][3][4][7]. Phase 1/2 and phase 3 clinical trials (TiNivo, TiNivo-2) have evaluated efficacy and safety. While early trials suggested promising efficacy (objective response rate ~56% and disease control rate ~96% in phase Ib/II), subsequent phase 3 studies found that the combination did not improve progression-free survival (PFS) compared to tivozanib alone in patients previously treated with immune checkpoint inhibitors[2][3][5][6][8]. Both agents are administered together: tivozanib is given orally and nivolumab intravenously.

Brand names
FOTIVDA + Opdivo
Other names
tivozanib-nivolumabTiNivo
02

Targets

VEGFR2 (Vascular endothelial growth factor receptor 2)PDCD1 (Programmed cell death protein 1 receptor)VEGFR-1 (Vascular endothelial growth factor receptor 1)VEGFR3 (Vascular endothelial growth factor receptor 3)

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