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항목
ADCCurated CoreFDAApproved
enfortumab vedotin (Padcev, ASG-22ME, enfortumab-vedotin-ejfv)
Astellas / Pfizer (Seagen)·Nectin-4
201 trials·t½ ADC ~3.4 days; free MMAE ~2.4 days
ADCCurated CoreFDAApproved
sacituzumab govitecan (Trodelvy, IMMU-132, sacituzumab-govitecan-hziy)
Gilead / Immunomedics·TROP2
242 trials·t½ ADC ~16 h; free SN-38 ~18 h
Overview
Program
Padcev (enfortumab vedotin)Trodelvy (sacituzumab govitecan)
Overview
Company
Astellas / Pfizer (Seagen)Gilead / Immunomedics
Overview
Modality
ADCADC
Overview
Target
Nectin-4TROP2
Overview
Indication
Locally advanced or metastatic urothelial carcinomaMetastatic triple-negative breast cancer, pretreated HR+/HER2− breast cancer
Overview
Phase
APPROVEDAPPROVED
Overview
Status
APPROVEDAPPROVED
Overview
Content status
Curated CoreCurated Core
Overview
Data Confidence
Data Confidence · HighData Confidence · High
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 standard of care in urothelial carcinoma with pembrolizumab.TROP2 class leader by approval history; now facing Datroway and other TROP2 ADCs.
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.
PK/PD
Half-life
ADC ~3.4 days; free MMAE ~2.4 daysADC ~16 h; free SN-38 ~18 h
PK/PD
Species
Cynomolgus monkey, ORR, PFS, OSMouse, ORR and PFS, ctDNA dynamics exploratory
PK/PD
Animal (cat.)
Human, NHP, In vitroHuman, Mouse, In vitro
PK/PD
Experiment
Pharmacokineticpd
Toxicology
Species
Cynomolgus monkey, Mouse, RatCynomolgus monkey, Mouse, 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
ORR 67.7%ORR 44%
Clinical
Reported ORR
67.7% (EV + pembrolizumab)44.0%
Clinical
Reported PFS
12.5 mo vs 6.3 mo (chemo)
Clinical
Reported OS
31.5 mo vs 16.1 mo (chemo)
Clinical
Result source
EV-302 / KEYNOTE-A39 (NCT04223856)ClinicalTrials.gov NCT04916002
Clinical
Program phase
APPROVEDAPPROVED
Clinical
Trial activity
No active/completed countsNo active/completed counts
Clinical
Trial ref
NCT04223856NCT04916002
Preclinical
Animal (cat.)
Human, Mouse, In vitroMouse