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항목
ADCCurated CoreFDAstaleApproved
datopotamab deruxtecan-dlnk (Datroway, DS-1062, Dato-DXd)
Daiichi Sankyo / AstraZeneca·TROP2
50 trials
Overview
Program
Datroway (datopotamab deruxtecan-dlnk)
Overview
Company
Daiichi Sankyo / AstraZeneca
Overview
Modality
ADC
Overview
Target
TROP2
Overview
Indication
HR-positive/HER2-negative breast cancer after specified prior therapies; EGFR-mutated NSCLC after specified prior therapies; first-line TNBC unsuitable for PD-1/PD-L1 therapy. Consult current US label.
Overview
Phase
APPROVED
Overview
Status
APPROVED
Overview
Content status
Curated Core
Overview
Data Confidence
Editorial scope · Curated Core
Overview
Development Signal
Development Signal · Established
Overview
Approval status
FDA approved
Positioning
Key differentiator
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 loss, SLFN11 status, and topoisomerase I pathway adaptation.
Positioning
Development positioning
Indication-specific; includes 1L TNBC unsuitable for PD-1/PD-L1 therapy
Technology
Payload
DXd (exatecan derivative, topoisomerase I inhibitor)
Technology
Linker
Tetrapeptide-based cleavable maleimide linker, DAR ~4
Technology
DAR
DAR 4
MoA
Mechanism
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 expression is not a required companion diagnostic; quantitative continuous scoring (QCS) is investigational.
Toxicology
Species
Rat, Hamster
Toxicology
Major finding
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/A
Clinical
Safety signal
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 64%
Clinical
Reported ORR
64% vs 30% (chemotherapy)
Clinical
Reported PFS
10.8 months vs 5.6 months (chemotherapy)
Clinical
Reported OS
23.7 months vs 18.7 months (chemotherapy)
Clinical
Result source
FDA approval report 2026-05-22 — TROPION-Breast02 (NCT05374512)
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
NCT05374512
Preclinical
Animal (cat.)
Mouse, In vitro