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loxo-435 + pembrolizumab + enfortumab vedotin
- Development stage
- Phase 3
- Lead developer
- Eli Lilly
- Modality
- Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
- Administration
- Intravenous
01
Overview
This is a combination of three agents under evaluation primarily for the treatment of urothelial carcinoma. - **LOXO-435** is a small molecule selective inhibitor of fibroblast growth factor receptor 3 (FGFR3), developed for FGFR3-altered cancers, especially urothelial carcinoma. - **Pembrolizumab** is a monoclonal antibody targeting programmed cell death protein 1 (PD-1), serving as an immune checkpoint inhibitor to activate T-cell responses against tumor cells. - **Enfortumab vedotin** is an antibody-drug conjugate targeting Nectin-4, highly expressed on urothelial carcinoma cells. It consists of a monoclonal antibody (enfortumab) linked to a cytotoxic agent (monomethyl auristatin E, MMAE), which disrupts microtubule assembly and induces apoptosis upon internalization[1][2][4][5]. This multi-agent combination is investigated to exploit synergy between FGFR3 blockade, immune checkpoint inhibition, and targeted cytotoxic delivery, mainly for metastatic or locally advanced urothelial carcinoma in clinical studies.
- Brand names
- Padcev (enfortumab vedotin)Keytruda (pembrolizumab)
- Other names
- enfortumab vedotin-ejfvAGS-22M6E (enfortumab vedotin)
02
Targets
FGFR3 (Fibroblast growth factor receptor 3)PVRL4 (Nectin cell adhesion molecule 4)PDCD1 (Programmed cell death protein 1 receptor)
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