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API CSV34행 · 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
enfortumab vedotin-ejfv (Padcev, ASG-22ME, enfortumab-vedotin-ejfv)
Astellas / Pfizer (Seagen)·Nectin-4
201 trials
ADCCurated CoreFDAstaleApproved
ado-trastuzumab emtansine (Kadcyla, T-DM1, Trastuzumab Emtansine)
Roche / Genentech·HER2
186 trials
ADCCurated CoreFDAstaleApproved
sacituzumab govitecan-hziy (Trodelvy, IMMU-132, sacituzumab-govitecan-hziy)
Gilead / Immunomedics·TROP2
242 trials
ADCCurated CoreFDAstalePhase 3
Polatuzumab Vedotin (Polatuzumab Vedotin)
Roche / Genentech·FRα
91 trials
Overview
Program
Enhertu (fam-trastuzumab deruxtecan-nxki)Padcev (enfortumab vedotin-ejfv)Kadcyla (ado-trastuzumab emtansine)Trodelvy (sacituzumab govitecan-hziy)Polatuzumab Vedotin
Overview
Company
Daiichi Sankyo / AstraZenecaAstellas / Pfizer (Seagen)Roche / GenentechGilead / ImmunomedicsRoche / Genentech
Overview
Modality
ADCADCADCADCADC
Overview
Target
HER2Nectin-4HER2TROP2FRα
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 labelLocally advanced or metastatic urothelial carcinomaHER2+ breast cancerTNBC: regimen-specific first-line and previously treated indications; HR-positive/HER2-negative breast cancer after specified prior therapies. Consult current US label.Large B-Cell Lymphoma
Overview
Phase
APPROVEDAPPROVEDAPPROVEDAPPROVEDPHASE_3
Overview
Status
APPROVEDAPPROVEDAPPROVEDAPPROVEDRECRUITING
Overview
Content status
Curated CoreCurated CoreCurated CoreCurated CoreCurated Core
Overview
Data Confidence
Editorial scope · Curated CoreEditorial scope · Curated CoreEditorial scope · Curated CoreEditorial scope · Curated CoreEditorial scope · Curated Core
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · Established
Overview
Approval status
FDA approvedFDA approvedFDA approvedFDA approvedFDA approved
Positioning
Key differentiator
High DAR (~8), bystander effect, HER2-low activityNectin-4 is near-uniformly expressed in urothelial carcinoma, giving an unusually clean tumor-selective target in that tissue.Stable linker, DAR ~3.5Very high DAR plus a deliberately unstable linker — extracellular SN-38 release gives bystander killing in TROP2-heterogeneous tumors.unique toxicities related to the antigen target, linker, or payload that have limited their development
Positioning
Known limitation
HER2 antigen loss/downregulation, payload efflux, and dose-limiting ILD/pneumonitis leading to discontinuation.Nectin-4 loss, MMAE efflux, and tubulin alterations.HER2 downregulation, lysosomal trapping, and efflux; superseded in 2L HER2+ mBC by trastuzumab deruxtecan (DESTINY-Breast03).TROP2 downregulation, TOP1 mutation, and ABC-transporter payload efflux.resistance to POLA in vivo
Positioning
Development positioning
Indication- and regimen-specific; includes 1L + pertuzumab in HER2-positive metastatic breast cancer1L with pembrolizumab; monotherapy in later lines2LRegimen-specific; includes 1L TNBC indications from June 2026—
Technology
Payload
DXd (topo-I inhibitor)MMAE (monomethyl auristatin E, tubulin inhibitor)DM1 (maytansine derivative)SN-38 (topoisomerase I inhibitor)vedotin, rituximab, cyclophosphamide, doxorubic
Technology
Linker
Cleavable tetrapeptideProtease-cleavable mc-vc-PAB, DAR ~3.8Non-cleavable stable thioether MCCHydrolyzable CL2A, DAR ~7.6linker, or payload that have limited their development
Technology
DAR
—DAR 3.8—DAR 7.6—
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.Binds Nectin-4 on urothelial tumor cells, internalizes, and releases MMAE after cathepsin B cleavage; microtubule disruption arrests mitosis and triggers apoptosis.Ado-trastuzumab emtansine (T-DM1) binds HER2 on tumor cells, is internalized, and MMAE is released after lysosomal degradation of the antibody in the non-cleavable SMCC linker system. MMAE disrupts microtubules, causing G2/M arrest and apoptosis.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.targeting specific cell surface antigens, many ADCs have also been associated with unique toxicities related to the antigen
MoA
Biomarker
HER2 expression (IHC/ISH per indication); higher systemic exposure associated with greater ILD incidence (FDA label §12.2).Nectin-4 expression is high in urothelial carcinoma; no companion diagnostic required.HER2 overexpression/amplification (IHC 3+ or ISH+ per label).TROP2 is broadly expressed in epithelial tumors; no companion diagnostic is required in the label.CD20 expression
Toxicology
Species
Cynomolgus monkey, NHP, Rat, HamsterCynomolgus monkey, Mouse, RatCynomolgus monkey, RatCynomolgus monkey, HamsterCynomolgus monkey, Mouse, Rat
Toxicology
Animal (cat.)
NHP—NHP—Mouse, Rat, NHP
Toxicology
Major finding
ILD-like lung findings at high exposureBoxed warning for serious skin reactions including SJS/TEN. Hyperglycemia, peripheral neuropathy, ocular surface toxicity, and pneumonitis also require monitoring.Thrombocytopenia, hepatotoxicityBoxed warning for severe neutropenia and severe diarrhea. Nausea, alopecia, fatigue, and rare hypersensitivity are common.Hepatotoxicity: Monitor liver enzymes and bilirubin
Toxicology
CRS
MinimalN/AMinimalN/A—
Toxicology
NOAEL
10 mg/kg————
Clinical
Safety signal
ILD-like lung findings at high exposureBoxed warning for serious skin reactions including SJS/TEN. Hyperglycemia, peripheral neuropathy, ocular surface toxicity, and pneumonitis also require monitoring.Thrombocytopenia, hepatotoxicityBoxed warning for severe neutropenia and severe diarrhea. Nausea, alopecia, fatigue, and rare hypersensitivity are common.Hepatotoxicity: Monitor liver enzymes and bilirubin
Clinical
Selected reported efficacy
ORR 87%95%—ORR 50%—
Clinical
Reported ORR
87% vs 81% (THP)——50% vs 47% (chemotherapy)—
Clinical
Reported PFS
40.7 months vs 26.9 months (THP)12.5 months vs 6.3 months (platinum chemotherapy)—9.7 months vs 6.9 months (chemotherapy)—
Clinical
Reported OS
Immature at the reported PFS analysis31.5 months vs 16.1 months (platinum chemotherapy)—Immature in FDA approval analysis—
Clinical
Result source
FDA label 2026, Table 28 — DESTINY-Breast09 (NCT04784715)FDA approval report 2023-12-15 — EV-302 (NCT04223856)—FDA approval report 2026-06-24 — ASCENT-03 (NCT05382299)—
Clinical
Program phase
APPROVEDAPPROVEDAPPROVEDAPPROVEDPHASE_3
Clinical
Trial activity
No active/completed countsNo active/completed countsNo active/completed countsNo active/completed countsNo active/completed counts
Clinical
Trial ref
NCT04784715NCT04223856—NCT05382299—
Preclinical
Animal (cat.)
Human, Mouse, In vitro—In vitroMouseRat