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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
mirvetuximab soravtansine-gynx (Elahere, IMGN853, mirvetuximab-soravtansine-gynx)
AbbVie / ImmunoGen·FRα (folate receptor alpha)
32 trials
ADCCurated CoreFDAstaleApproved
Tisotumab Vedotin (Tisotumab Vedotin)
Genmab / Pfizer·Solid Malignancies
14 trials
Overview
Program
Padcev (enfortumab vedotin-ejfv)Elahere (mirvetuximab soravtansine-gynx)Tisotumab Vedotin
Overview
Company
Astellas / Pfizer (Seagen)AbbVie / ImmunoGenGenmab / Pfizer
Overview
Modality
ADCADCADC
Overview
Target
Nectin-4FRα (folate receptor alpha)Solid Malignancies
Overview
Indication
Locally advanced or metastatic urothelial carcinomaFRα-positive platinum-resistant ovarian, fallopian tube, or primary peritoneal cancerColorectal Neoplasms; Carcinoma, Non-Small-Cell Lung
Overview
Phase
APPROVEDAPPROVEDAPPROVED
Overview
Status
APPROVEDAPPROVEDAPPROVED
Overview
Content status
Curated CoreCurated CoreCurated Core
Overview
Data Confidence
Editorial scope · Curated CoreEditorial scope · Curated CoreEditorial scope · Curated Core
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · Established
Overview
Approval status
FDA approvedFDA approvedFDA approved
Positioning
Key differentiator
Nectin-4 is near-uniformly expressed in urothelial carcinoma, giving an unusually clean tumor-selective target in that tissue.FRα is overexpressed in ovarian cancer but sparse in normal tissue, and the label requires IHC-confirmed expression.—
Positioning
Known limitation
Nectin-4 loss, MMAE efflux, and tubulin alterations.FRα downregulation and multidrug-resistance transporter upregulation.—
Positioning
Development positioning
1L with pembrolizumab; monotherapy in later lines2L–4L platinum-resistant—
Technology
Payload
MMAE (monomethyl auristatin E, tubulin inhibitor)DM4 (maytansinoid, tubulin inhibitor)—
Technology
Linker
Protease-cleavable mc-vc-PAB, DAR ~3.8Cleavable sulfo-SPDB disulfide, DAR ~3.5—
Technology
DAR
DAR 3.8DAR 3.5—
MoA
Mechanism
Binds Nectin-4 on urothelial tumor cells, internalizes, and releases MMAE after cathepsin B cleavage; microtubule disruption arrests mitosis and triggers apoptosis.Binds FRα, internalizes via receptor-mediated endocytosis, and releases DM4 after disulfide reduction; tubulin disruption causes mitotic arrest, with lipophilic S-methyl-DM4 giving bystander activity.—
MoA
Biomarker
Nectin-4 expression is high in urothelial carcinoma; no companion diagnostic required.FRα IHC (VENTANA FOLR1 RxDx), PS2+ scoring with ≥75% of tumor cells staining.—
Toxicology
Species
Cynomolgus monkey, Mouse, RatRat—
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 ocular toxicity — keratopathy, blurred vision, and dry eye. Peripheral neuropathy, nausea, and fatigue are also common.Pneumonitis: Severe, life-threatening, or fatal pneumonitis may occur
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 ocular toxicity — keratopathy, blurred vision, and dry eye. Peripheral neuropathy, nausea, and fatigue are also common.Pneumonitis: Severe, life-threatening, or fatal pneumonitis may occur
Clinical
Selected reported efficacy
95%ORR 42%—
Clinical
Reported ORR
—42% vs 16% (chemotherapy; rounded in NCI report)—
Clinical
Reported PFS
12.5 months vs 6.3 months (platinum chemotherapy)5.6 months vs 4.0 months (chemotherapy)—
Clinical
Reported OS
31.5 months vs 16.1 months (platinum chemotherapy)16.5 months vs 12.8 months (chemotherapy)—
Clinical
Result source
FDA approval report 2023-12-15 — EV-302 (NCT04223856)NCI approval analysis 2024 — MIRASOL (NCT04209855)—
Clinical
Program phase
APPROVEDAPPROVEDAPPROVED
Clinical
Trial activity
No active/completed countsNo active/completed countsNo active/completed counts
Clinical
Trial ref
NCT04223856NCT04209855—