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항목
ADCCurated CoreFDAApproved
sacituzumab govitecan (Trodelvy, IMMU-132, sacituzumab-govitecan-hziy)
Gilead / Immunomedics·TROP2
242 trials·t½ ADC ~16 h; free SN-38 ~18 h
ADCCurated CoreFDAApproved
datopotamab deruxtecan (Datroway, DS-1062, Dato-DXd, datopotamab-deruxtecan-dlnk)
Daiichi Sankyo / AstraZeneca·TROP2
50 trials·t½ ADC ~6 days; released DXd cleared rapidly
Overview
Program
Trodelvy (sacituzumab govitecan)Datroway (datopotamab deruxtecan)
Overview
Company
Gilead / ImmunomedicsDaiichi Sankyo / AstraZeneca
Overview
Modality
ADCADC
Overview
Target
TROP2TROP2
Overview
Indication
Metastatic triple-negative breast cancer, pretreated HR+/HER2− breast cancerHR+/HER2− breast cancer; EGFR-mutated non-small cell lung 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
Very high DAR plus a deliberately unstable linker — extracellular SN-38 release gives bystander killing in TROP2-heterogeneous tumors.Same DXd chemistry that made Enhertu work, aimed at TROP2 — high plasma stability with a short-half-life payload to limit systemic exposure.
Positioning
Known limitation
TROP2 downregulation, TOP1 mutation, and ABC-transporter payload efflux.TROP2 loss, SLFN11 status, and topoisomerase I pathway adaptation.
Positioning
Development positioning
TROP2 class leader by approval history; now facing Datroway and other TROP2 ADCs.Second TROP2 ADC to market; competes with Trodelvy on tolerability rather than novelty of target.
Technology
Payload
SN-38 (topoisomerase I inhibitor)DXd (exatecan derivative, topoisomerase I inhibitor)
Technology
Linker
Hydrolyzable CL2A, DAR ~7.6Tetrapeptide-based cleavable maleimide linker, DAR ~4
Technology
DAR
DAR 7.6DAR 4
MoA
Mechanism
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.Anti-TROP2 antibody delivers DXd intracellularly after lysosomal linker cleavage; topoisomerase I inhibition drives DNA damage, with membrane-permeable payload producing a bystander effect.
MoA
Biomarker
TROP2 is broadly expressed in epithelial tumors; no companion diagnostic is required in the label.TROP2 expression is not a required companion diagnostic; quantitative continuous scoring (QCS) is investigational.
PK/PD
Half-life
ADC ~16 h; free SN-38 ~18 hADC ~6 days; released DXd cleared rapidly
PK/PD
Species
Mouse, ORR and PFS, ctDNA dynamics exploratoryCynomolgus monkey, Mouse, PFS by BICR, ctDNA and TROP2 QCS exploratory
PK/PD
Animal (cat.)
Human, Mouse, In vitroHuman, Mouse, NHP, In vitro
PK/PD
Experiment
pdpd
Toxicology
Species
Cynomolgus monkey, Mouse, HamsterMouse, Rat, Hamster
Toxicology
Major finding
Boxed warning for severe neutropenia and severe diarrhea. Nausea, alopecia, fatigue, and rare hypersensitivity are common.Stomatitis, dry eye and keratitis, nausea, and alopecia. Interstitial lung disease is a class warning for DXd conjugates and requires prompt steroid intervention.
Toxicology
CRS
N/AN/A
Clinical
Safety signal
Boxed warning for severe neutropenia and severe diarrhea. Nausea, alopecia, fatigue, and rare hypersensitivity are common.Stomatitis, dry eye and keratitis, nausea, and alopecia. Interstitial lung disease is a class warning for DXd conjugates and requires prompt steroid intervention.
Clinical
Selected reported efficacy
ORR 44%ORR 79%
Clinical
Reported ORR
44.0%74%
Clinical
Reported PFS
4.4
Clinical
Reported OS
12.9
Clinical
Result source
ClinicalTrials.gov NCT04916002ClinicalTrials.gov NCT04656652
Clinical
Program phase
APPROVEDAPPROVED
Clinical
Trial activity
No active/completed countsNo active/completed counts
Clinical
Trial ref
NCT04916002NCT04656652
Preclinical
Animal (cat.)
MouseMouse, In vitro