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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
disitamab vedotin (Disitamab Vedotin, RC48)
RemeGen·HER2
159 trials·t½ ~5 days (ADC, clinical PK)
Overview
Program
Padcev (enfortumab vedotin)Disitamab Vedotin (RC48)
Overview
Company
Astellas / Pfizer (Seagen)RemeGen
Overview
Modality
ADCADC
Overview
Target
Nectin-4HER2
Overview
Indication
Locally advanced or metastatic urothelial carcinomaHER2+ urothelial, gastric, breast
Overview
Phase
APPROVEDAPPROVED
Overview
Status
APPROVEDACTIVE
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.Novel anti-HER2 mAb with distinct epitope
Positioning
Known limitation
Nectin-4 loss, MMAE efflux, and tubulin alterations.resistance mechanisms, optimize payload delivery, and minimize off-target toxicity
Positioning
Development positioning
1L standard of care in urothelial carcinoma with pembrolizumab.Lower ILD signal vs DXd in some datasets
Technology
Payload
MMAE (monomethyl auristatin E, tubulin inhibitor)MMAE
Technology
Linker
Protease-cleavable mc-vc-PAB, DAR ~3.8Cleavable
Technology
DAR
DAR 3.8
MoA
Mechanism
Binds Nectin-4 on urothelial tumor cells, internalizes, and releases MMAE after cathepsin B cleavage; microtubule disruption arrests mitosis and triggers apoptosis.Disitamab vedotin binds a distinct HER2 epitope (different from trastuzumab), internalizes, and releases MMAE via cleavable linker, causing microtubule disruption and apoptosis.
MoA
Biomarker
Nectin-4 expression is high in urothelial carcinoma; no companion diagnostic required.HER2 expression (IHC); activity in HER2+ urothelial and gastric cancers.
PK/PD
Half-life
ADC ~3.4 days; free MMAE ~2.4 days~5 days (ADC, clinical PK)
PK/PD
Species
Cynomolgus monkey, ORR, PFS, OSMouse, ORR in HER2+ UC/gastric
PK/PD
Animal (cat.)
Human, NHP, In vitroHuman, Mouse, In vitro
PK/PD
Experiment
Pharmacokineticpd
Toxicology
Species
Cynomolgus monkey, Mouse, RatCynomolgus monkey, Mouse
Toxicology
Animal (cat.)
NHP
Toxicology
Major finding
Boxed warning for serious skin reactions including SJS/TEN. Hyperglycemia, peripheral neuropathy, ocular surface toxicity, and pneumonitis also require monitoring.Hematologic toxicity and peripheral neuropathy class effects of MMAE; ILD reported at lower frequency than DXd ADCs in published datasets.
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.Hematologic toxicity and peripheral neuropathy class effects of MMAE; ILD reported at lower frequency than DXd ADCs in published datasets.
Clinical
Selected reported efficacy
ORR 67.7%
Clinical
Reported ORR
67.7% (EV + pembrolizumab)
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)
Clinical
Program phase
APPROVEDAPPROVED
Clinical
Trial activity
No active/completed countsNo active/completed counts
Clinical
Trial ref
NCT04223856
Preclinical
Animal (cat.)
Human, Mouse, In vitro