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API CSV36행 · 5개 프로그램

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항목
ADCCurated CoreFDAstaleApproved
trastuzumab deruxtecan (Enhertu, T-DXd, DS-8201, TDxd)
Daiichi Sankyo / AstraZeneca·HER2
243 trials
ADCCurated CoreFDAstaleApproved
datopotamab deruxtecan-dlnk (Datroway, DS-1062, Dato-DXd)
Daiichi Sankyo / AstraZeneca·TROP2
50 trials
ADCCurated CoreFDAstaleApproved
Tisotumab Vedotin (Tisotumab Vedotin)
Genmab / Pfizer·Solid Malignancies
14 trials
ADCCurated CoreFDAstaleApproved
telisotuzumab vedotin (Emrelis, ABBV-399, Teliso-V, telisotuzumab-vedotin-tllv)
AbbVie·c-Met
12 trials·t½ ADC in the range of days; free MMAE shorter
ADCLimited DatastalePhase 3
Platinum Based Chemotherapy (Platinum Based Chemotherapy)
Merck Sharp & Dohme LLC·Ovarian Cancer
128 trials
Overview
Program
Enhertu (fam-trastuzumab deruxtecan-nxki)Datroway (datopotamab deruxtecan-dlnk)Tisotumab VedotinEmrelis (telisotuzumab vedotin)Platinum Based Chemotherapy
Overview
Company
Daiichi Sankyo / AstraZenecaDaiichi Sankyo / AstraZenecaGenmab / PfizerAbbVieMerck Sharp & Dohme LLC
Overview
Modality
ADCADCADCADCADC
Overview
Target
HER2TROP2Solid Malignanciesc-MetOvarian Cancer
Overview
Indication
HER2-positive breast cancer (including regimen-specific first-line and early-stage indications); HER2-low/ultralow breast cancer, HER2-positive gastric cancer, HER2-mutant NSCLC and HER2-positive solid tumors: consult the current US labelHR-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.Colorectal Neoplasms; Carcinoma, Non-Small-Cell LungPreviously treated locally advanced or metastatic non-squamous NSCLC with high c-Met protein overexpressionNonsquamous Non-small Cell Lung Cancer; EGFR L858R
Overview
Phase
APPROVEDAPPROVEDAPPROVEDAPPROVEDPHASE_3
Overview
Status
APPROVEDAPPROVEDAPPROVEDAPPROVEDRECRUITING
Overview
Content status
Curated CoreCurated CoreCurated CoreCurated CoreLimited Data
Overview
Data Confidence
Editorial scope · Curated CoreEditorial scope · Curated CoreEditorial scope · Curated CoreEditorial scope · Curated CoreEditorial scope · limited data
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · Emerging
Overview
Approval status
FDA approvedFDA approvedFDA approvedFDA approvedInvestigational
Positioning
Key differentiator
High DAR (~8), bystander effect, HER2-low activitySame DXd chemistry that made Enhertu work, aimed at TROP2 — high plasma stability with a short-half-life payload to limit systemic exposure.—Selects high c-Met protein overexpression by IHC, not MET gene mutation. That split is the first row versus MET TKIs.—
Positioning
Known limitation
HER2 antigen loss/downregulation, payload efflux, and dose-limiting ILD/pneumonitis leading to discontinuation.TROP2 loss, SLFN11 status, and topoisomerase I pathway adaptation.—c-Met down-regulation, MMAE efflux, and histologic transformation.—
Positioning
Development positioning
Indication- and regimen-specific; includes 1L + pertuzumab in HER2-positive metastatic breast cancerIndication-specific; includes 1L TNBC unsuitable for PD-1/PD-L1 therapy—2L+—
Technology
Payload
DXd (topo-I inhibitor)DXd (exatecan derivative, topoisomerase I inhibitor)—MMAE (microtubule inhibitor)vedotin (ARON-2EV study)
Technology
Linker
Cleavable tetrapeptideTetrapeptide-based cleavable maleimide linker, DAR ~4—Cleavable vc linker, vedotin chemistry—
Technology
DAR
—DAR 4———
MoA
Mechanism
Fam-trastuzumab deruxtecan is a HER2-directed antibody-drug conjugate: humanized anti-HER2 IgG1 linked via a cleavable tetrapeptide linker to DXd, a membrane-permeable topoisomerase I inhibitor. After binding HER2 on tumor cells, the conjugate is internalized; lysosomal proteases cleave the linker and release DXd, causing DNA damage and apoptosis. Released DXd can exert a bystander effect in neighboring cells.Anti-TROP2 antibody delivers DXd intracellularly after lysosomal linker cleavage; topoisomerase I inhibition drives DNA damage, with membrane-permeable payload producing a bystander effect.—Anti-c-Met antibody binds and internalizes; the protease-cleavable linker releases MMAE, which disrupts microtubules and kills the cell plus neighbors via bystander diffusion.targeting oxidative stress, hypoxia, persistent DNA damage, immune signaling
MoA
Biomarker
HER2 expression (IHC/ISH per indication); higher systemic exposure associated with greater ILD incidence (FDA label §12.2).TROP2 expression is not a required companion diagnostic; quantitative continuous scoring (QCS) is investigational.—VENTANA MET (SP44) companion diagnostic. High overexpression is ≥50% of cells with 3+ staining, not MET exon 14 skipping.biomarker-embedded clinical trials, molecular subtype-stratified patient selection, and rigorous evaluation o
PK/PD
Half-life
———ADC in the range of days; free MMAE shorter—
PK/PD
Animal (cat.)
———Human—
Toxicology
Species
Cynomolgus monkey, NHP, Rat, HamsterRat, Hamster———
Toxicology
Animal (cat.)
NHP————
Toxicology
Major finding
ILD-like lung findings at high exposureStomatitis, dry eye and keratitis, nausea, and alopecia. Interstitial lung disease is a class warning for DXd conjugates and requires prompt steroid intervention.Pneumonitis: Severe, life-threatening, or fatal pneumonitis may occurPeripheral neuropathy, fatigue, decreased appetite, and peripheral edema are common. Grade 3–4 lab signals include lymphopenia and transaminase rises.—
Toxicology
CRS
MinimalN/A—N/A—
Toxicology
NOAEL
10 mg/kg————
Clinical
Safety signal
ILD-like lung findings at high exposureStomatitis, dry eye and keratitis, nausea, and alopecia. Interstitial lung disease is a class warning for DXd conjugates and requires prompt steroid intervention.Pneumonitis: Severe, life-threatening, or fatal pneumonitis may occurPeripheral neuropathy, fatigue, decreased appetite, and peripheral edema are common. Grade 3–4 lab signals include lymphopenia and transaminase rises.—
Clinical
Selected reported efficacy
ORR 87%ORR 64%———
Clinical
Reported ORR
87% vs 81% (THP)64% vs 30% (chemotherapy)———
Clinical
Reported PFS
40.7 months vs 26.9 months (THP)10.8 months vs 5.6 months (chemotherapy)———
Clinical
Reported OS
Immature at the reported PFS analysis23.7 months vs 18.7 months (chemotherapy)———
Clinical
Result source
FDA label 2026, Table 28 — DESTINY-Breast09 (NCT04784715)FDA approval report 2026-05-22 — TROPION-Breast02 (NCT05374512)———
Clinical
Program phase
APPROVEDAPPROVEDAPPROVEDAPPROVEDPHASE_3
Clinical
Trial activity
No active/completed countsNo active/completed countsNo active/completed counts—No active/completed counts
Clinical
Trial ref
NCT04784715NCT05374512———
Preclinical
Animal (cat.)
Human, Mouse, In vitroMouse, In vitro———