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항목
ADCCurated CoreFDAstaleApproved
datopotamab deruxtecan-dlnk (Datroway, DS-1062, Dato-DXd)
Daiichi Sankyo / AstraZeneca·TROP2
50 trials
AntibodyCurated CoreFDAstaleApproved
cetuximab (Erbitux)
Eli Lilly / Merck KGaA·EGFR
942 trials
ADCLimited DatastalePhase 3
Platinum Based Chemotherapy (Platinum Based Chemotherapy)
Merck Sharp & Dohme LLC·Ovarian Cancer
128 trials
Overview
Program
Datroway (datopotamab deruxtecan-dlnk)Erbitux (cetuximab)Platinum Based Chemotherapy
Overview
Company
Daiichi Sankyo / AstraZenecaEli Lilly / Merck KGaAMerck Sharp & Dohme LLC
Overview
Modality
ADCANTIBODYADC
Overview
Target
TROP2EGFROvarian Cancer
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.US label: head and neck squamous cell cancer and biomarker-selected colorectal cancer; regimen-specific indicationsNonsquamous Non-small Cell Lung Cancer; EGFR L858R
Overview
Phase
APPROVEDAPPROVEDPHASE_3
Overview
Status
APPROVEDAPPROVEDRECRUITING
Overview
Content status
Curated CoreCurated CoreLimited Data
Overview
Data Confidence
Editorial scope · Curated CoreEditorial scope · Curated CoreEditorial scope · limited data
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · Emerging
Overview
Approval status
FDA approvedFDA approvedInvestigational
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.novel strategies of biotherapeutics—
Positioning
Known limitation
TROP2 loss, SLFN11 status, and topoisomerase I pathway adaptation.resistance to anti-EGFR therapy by transcriptional reprogramming in patient-derived colorectal cancer models—
Positioning
Development positioning
Indication-specific; includes 1L TNBC unsuitable for PD-1/PD-L1 therapy——
Technology
Payload
DXd (exatecan derivative, topoisomerase I inhibitor)—vedotin (ARON-2EV study)
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.targeting the epidermal growth factor receptortargeting oxidative stress, hypoxia, persistent DNA damage, immune signaling
MoA
Biomarker
TROP2 expression is not a required companion diagnostic; quantitative continuous scoring (QCS) is investigational.EGFR SR could be established with highbiomarker-embedded clinical trials, molecular subtype-stratified patient selection, and rigorous evaluation o
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
APPROVEDAPPROVEDPHASE_3
Clinical
Trial activity
No active/completed countsNo active/completed countsNo active/completed counts
Clinical
Trial ref
NCT05374512——
Preclinical
Animal (cat.)
Mouse, In vitro——