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API CSV33행 · 5개 프로그램

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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
ADCCurated CoreFDAstaleApproved
telisotuzumab vedotin (Emrelis, ABBV-399, Teliso-V, telisotuzumab-vedotin-tllv)
AbbVie·c-Met
12 trials·t½ ADC in the range of days; free MMAE shorter
ADCLimited DatastalePhase 3
Platinum Based Chemotherapy (Platinum Based Chemotherapy)
Merck Sharp & Dohme LLC·Ovarian Cancer
128 trials
Overview
Program
Padcev (enfortumab vedotin-ejfv)Elahere (mirvetuximab soravtansine-gynx)Tisotumab VedotinEmrelis (telisotuzumab vedotin)Platinum Based Chemotherapy
Overview
Company
Astellas / Pfizer (Seagen)AbbVie / ImmunoGenGenmab / PfizerAbbVieMerck Sharp & Dohme LLC
Overview
Modality
ADCADCADCADCADC
Overview
Target
Nectin-4FRα (folate receptor alpha)Solid Malignanciesc-MetOvarian Cancer
Overview
Indication
Locally advanced or metastatic urothelial carcinomaFRα-positive platinum-resistant ovarian, fallopian tube, or primary peritoneal cancerColorectal Neoplasms; Carcinoma, Non-Small-Cell LungPreviously treated locally advanced or metastatic non-squamous NSCLC with high c-Met protein overexpressionNonsquamous Non-small Cell Lung Cancer; EGFR L858R
Overview
Phase
APPROVEDAPPROVEDAPPROVEDAPPROVEDPHASE_3
Overview
Status
APPROVEDAPPROVEDAPPROVEDAPPROVEDRECRUITING
Overview
Content status
Curated CoreCurated CoreCurated CoreCurated CoreLimited Data
Overview
Data Confidence
Editorial scope · Curated CoreEditorial scope · Curated CoreEditorial scope · Curated CoreEditorial scope · Curated CoreEditorial scope · limited data
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · Emerging
Overview
Approval status
FDA approvedFDA approvedFDA approvedFDA approvedInvestigational
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.—Selects high c-Met protein overexpression by IHC, not MET gene mutation. That split is the first row versus MET TKIs.—
Positioning
Known limitation
Nectin-4 loss, MMAE efflux, and tubulin alterations.FRα downregulation and multidrug-resistance transporter upregulation.—c-Met down-regulation, MMAE efflux, and histologic transformation.—
Positioning
Development positioning
1L with pembrolizumab; monotherapy in later lines2L–4L platinum-resistant—2L+—
Technology
Payload
MMAE (monomethyl auristatin E, tubulin inhibitor)DM4 (maytansinoid, tubulin inhibitor)—MMAE (microtubule inhibitor)vedotin (ARON-2EV study)
Technology
Linker
Protease-cleavable mc-vc-PAB, DAR ~3.8Cleavable sulfo-SPDB disulfide, DAR ~3.5—Cleavable vc linker, vedotin chemistry—
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.—Anti-c-Met antibody binds and internalizes; the protease-cleavable linker releases MMAE, which disrupts microtubules and kills the cell plus neighbors via bystander diffusion.targeting oxidative stress, hypoxia, persistent DNA damage, immune signaling
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.—VENTANA MET (SP44) companion diagnostic. High overexpression is ≥50% of cells with 3+ staining, not MET exon 14 skipping.biomarker-embedded clinical trials, molecular subtype-stratified patient selection, and rigorous evaluation o
PK/PD
Half-life
———ADC in the range of days; free MMAE shorter—
PK/PD
Animal (cat.)
———Human—
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 occurPeripheral neuropathy, fatigue, decreased appetite, and peripheral edema are common. Grade 3–4 lab signals include lymphopenia and transaminase rises.—
Toxicology
CRS
N/AN/A—N/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 occurPeripheral neuropathy, fatigue, decreased appetite, and peripheral edema are common. Grade 3–4 lab signals include lymphopenia and transaminase rises.—
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
APPROVEDAPPROVEDAPPROVEDAPPROVEDPHASE_3
Clinical
Trial activity
No active/completed countsNo active/completed countsNo active/completed counts—No active/completed counts
Clinical
Trial ref
NCT04223856NCT04209855———