Drug intelligence / Profile preview

ivonescimab + enfortumab vedotin

Development stage
Phase 3
Lead developer
Akeso
Modality
Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

Ivonescimab + enfortumab vedotin (also referred to as ivonescimab + RP3D, where RP3D represents the recommended Phase III dose of ivonescimab combined with enfortumab vedotin) is an investigational combination regimen being developed by Summit Therapeutics for the treatment of genitourinary malignancies, specifically urothelial carcinoma (bladder cancer). Ivonescimab (SMT112) is a potential first-in-class tetravalent bispecific antibody that simultaneously targets programmed cell death protein 1 (PD-1) and vascular endothelial growth factor A (VEGF-A), combining immune checkpoint inhibition with antiangiogenic activity. Enfortumab vedotin (Padcev) is an antibody-drug conjugate (ADC) targeting Nectin-4, which delivers the microtubule-disrupting agent monomethyl auristatin E (MMAE) directly to tumor cells. The combination is being evaluated in the global, multi-regional Phase II/III HARMONi-GU1 trial as a first-line therapy for patients with previously untreated locally advanced or metastatic urothelial carcinoma, comparing its efficacy and safety against the standard of care regimen of pembrolizumab plus enfortumab vedotin.

Other names
SMT112 + EVSMT112 + PadcevSMT112 + RP3DSMT112 + enfortumab vedotinivonescimab + EVivonescimab + Padcevivonescimab + RP3D
02

Targets

PVRL4 (Nectin cell adhesion molecule 4)PDCD1 (Programmed cell death protein 1 receptor)CD274 (Programmed cell death protein 1 ligand 1)VEGFA (Vascular endothelial growth factor A)VEGFR2 (Vascular endothelial growth factor receptor 2)

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