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항목
ADCCurated CoreFDAstaleApproved
enfortumab vedotin-ejfv (Padcev, ASG-22ME, enfortumab-vedotin-ejfv)
Astellas / Pfizer (Seagen)·Nectin-4
201 trials
ADCCurated CoreFDAstaleApproved
sacituzumab govitecan-hziy (Trodelvy, IMMU-132, sacituzumab-govitecan-hziy)
Gilead / Immunomedics·TROP2
242 trials
Overview
Program
Padcev (enfortumab vedotin-ejfv)Trodelvy (sacituzumab govitecan-hziy)
Overview
Company
Astellas / Pfizer (Seagen)Gilead / Immunomedics
Overview
Modality
ADCADC
Overview
Target
Nectin-4TROP2
Overview
Indication
Locally advanced or metastatic urothelial carcinomaTNBC: regimen-specific first-line and previously treated indications; HR-positive/HER2-negative breast cancer after specified prior therapies. Consult current US label.
Overview
Phase
APPROVEDAPPROVED
Overview
Status
APPROVEDAPPROVED
Overview
Content status
Curated CoreCurated Core
Overview
Data Confidence
Editorial scope · Curated CoreEditorial scope · Curated Core
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · Established
Overview
Approval status
FDA approvedFDA approved
Positioning
Key differentiator
Nectin-4 is near-uniformly expressed in urothelial carcinoma, giving an unusually clean tumor-selective target in that tissue.Very high DAR plus a deliberately unstable linker — extracellular SN-38 release gives bystander killing in TROP2-heterogeneous tumors.
Positioning
Known limitation
Nectin-4 loss, MMAE efflux, and tubulin alterations.TROP2 downregulation, TOP1 mutation, and ABC-transporter payload efflux.
Positioning
Development positioning
1L with pembrolizumab; monotherapy in later linesRegimen-specific; includes 1L TNBC indications from June 2026
Technology
Payload
MMAE (monomethyl auristatin E, tubulin inhibitor)SN-38 (topoisomerase I inhibitor)
Technology
Linker
Protease-cleavable mc-vc-PAB, DAR ~3.8Hydrolyzable CL2A, DAR ~7.6
Technology
DAR
DAR 3.8DAR 7.6
MoA
Mechanism
Binds Nectin-4 on urothelial tumor cells, internalizes, and releases MMAE after cathepsin B cleavage; microtubule disruption arrests mitosis and triggers apoptosis.Anti-TROP2 antibody binds and internalizes; the hydrolyzable linker releases SN-38 both intracellularly and in the tumor microenvironment, inhibiting topoisomerase I and causing lethal DNA double-strand breaks.
MoA
Biomarker
Nectin-4 expression is high in urothelial carcinoma; no companion diagnostic required.TROP2 is broadly expressed in epithelial tumors; no companion diagnostic is required in the label.
Toxicology
Species
Cynomolgus monkey, Mouse, RatCynomolgus monkey, Hamster
Toxicology
Major finding
Boxed warning for serious skin reactions including SJS/TEN. Hyperglycemia, peripheral neuropathy, ocular surface toxicity, and pneumonitis also require monitoring.Boxed warning for severe neutropenia and severe diarrhea. Nausea, alopecia, fatigue, and rare hypersensitivity are common.
Toxicology
CRS
N/AN/A
Clinical
Safety signal
Boxed warning for serious skin reactions including SJS/TEN. Hyperglycemia, peripheral neuropathy, ocular surface toxicity, and pneumonitis also require monitoring.Boxed warning for severe neutropenia and severe diarrhea. Nausea, alopecia, fatigue, and rare hypersensitivity are common.
Clinical
Selected reported efficacy
95%ORR 50%
Clinical
Reported ORR
—50% vs 47% (chemotherapy)
Clinical
Reported PFS
12.5 months vs 6.3 months (platinum chemotherapy)9.7 months vs 6.9 months (chemotherapy)
Clinical
Reported OS
31.5 months vs 16.1 months (platinum chemotherapy)Immature in FDA approval analysis
Clinical
Result source
FDA approval report 2023-12-15 — EV-302 (NCT04223856)FDA approval report 2026-06-24 — ASCENT-03 (NCT05382299)
Clinical
Program phase
APPROVEDAPPROVED
Clinical
Trial activity
No active/completed countsNo active/completed counts
Clinical
Trial ref
NCT04223856NCT05382299
Preclinical
Animal (cat.)
—Mouse