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Drug intelligence / Profile preview
Lu-EVS459
- Development stage
- Phase 1
- Modality
- Antibody-Radionuclide Conjugates → Antibody Conjugates → Antibody-Based Therapeutics, Peptides
- Administration
- Intravenous
01
Overview
Lu-EVS459 (also known as GIZ943 or [177Lu]Lu-EVS459) is an investigational peptide-based radioligand therapy developed by Novartis. It consists of the therapeutic beta-emitting radionuclide lutetium-177 linked to EVS459, a low-molecular-weight ligand that selectively targets folate receptor alpha (FRα, encoded by FOLR1). FRα is highly overexpressed in several solid tumors, including high-grade serous ovarian cancer and non-small cell lung cancer (NSCLC). Upon binding to FRα on the surface of cancer cells, the radioconjugate is internalized, delivering localized cytotoxic beta radiation that induces DNA damage and tumor cell death. A Phase 1 first-in-human clinical trial was initiated to evaluate the safety, tolerability, and dosimetry of Lu-EVS459, alongside PET imaging using the gallium-68-labeled diagnostic counterpart, Ga-EVS459. However, in April 2025, Novartis discontinued the development of GIZ943/Lu-EVS459 due to safety concerns and an unfavorable benefit-risk assessment observed in the Phase 1 study.
- Other names
- [177Lu]Lu-EVS459lutetium Lu 177 EVS459lutetium-177-labeled EVS459lutetium177-labeled EVS459lutetium 177-labeled EVS459
02
Targets
FOLR1 (FRα)
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