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API CSV33행 · 4개 프로그램

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항목
AntibodyCurated CoreFDAstaleApproved
pembrolizumab (Keytruda)
Merck·PD-1
1669 trials
AntibodyCurated CoreFDAstaleApproved
trastuzumab (Herceptin, Ogivri, Herzuma)
Roche / Genentech·HER2
1100 trials
AntibodyCurated CoreFDAstaleApproved
atezolizumab (Tecentriq, MPDL3280A)
Roche / Genentech·PD-L1
693 trials
ADCCurated CoreFDAstaleApproved
trastuzumab deruxtecan (Enhertu, T-DXd, DS-8201, TDxd)
Daiichi Sankyo / AstraZeneca·HER2
243 trials
Overview
Program
Keytruda (pembrolizumab)Herceptin (trastuzumab)Tecentriq (atezolizumab)Enhertu (fam-trastuzumab deruxtecan-nxki)
Overview
Company
MerckRoche / GenentechRoche / GenentechDaiichi Sankyo / AstraZeneca
Overview
Modality
ANTIBODYANTIBODYANTIBODYADC
Overview
Target
PD-1HER2PD-L1HER2
Overview
Indication
Multiple solid tumorsHER2+ breast cancer, HER2+ gastric/GEJ adenocarcinomaNSCLC, SCLC, HCC, TNBC, urothelial carcinoma, and othersHER2-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 label
Overview
Phase
APPROVEDAPPROVEDAPPROVEDAPPROVED
Overview
Status
APPROVEDAPPROVEDAPPROVEDAPPROVED
Overview
Content status
Curated CoreCurated CoreCurated CoreCurated Core
Overview
Data Confidence
Editorial scope · Curated CoreEditorial scope · Curated CoreEditorial scope · Curated CoreEditorial scope · Curated Core
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · Established
Overview
Approval status
FDA approvedFDA approvedFDA approvedFDA approved
Positioning
Key differentiator
Broad tumor-agnostic biomarker strategies (MSI-H, TMB)novel bifunctional chelator (2E-C-NETA) for applications in 177 Lu-based TRTnovel agents have been approved in recent years (including systemic pembrolizumab, nogapendekin alfa inbakicept-pmln, N-803),High DAR (~8), bystander effect, HER2-low activity
Positioning
Known limitation
Loss of antigen presentation (β2M, JAK1/2), alternate checkpoints (TIM-3, LAG-3), and immunosuppressive TME.resistance to trastuzumab-based targeted therapy and limited intratumoral antibody penetration continue to restrict clinical outcomesresistance to existing therapiesHER2 antigen loss/downregulation, payload efflux, and dose-limiting ILD/pneumonitis leading to discontinuation.
Positioning
Development positioning
———Indication- and regimen-specific; includes 1L + pertuzumab in HER2-positive metastatic breast cancer
Technology
Payload
———DXd (topo-I inhibitor)
Technology
Linker
———Cleavable tetrapeptide
MoA
Mechanism
Pembrolizumab is an IgG4 humanized monoclonal antibody that binds PD-1 on T cells and blocks interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including antitumor response.Trastuzumab binds domain IV of HER2, inhibiting ligand-independent HER2 signaling, mediating ADCC via Fcγ receptors, and inducing internalization/degradation of HER2.Atezolizumab binds PD-L1 and blocks its interaction with PD-1 and B7.1 (CD80), enabling restoration of antitumor T-cell responses without direct PD-1 engagement on T cells.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.
MoA
Biomarker
PD-L1 CPS/TPS (tumor-specific), MSI-H/dMMR, TMB-H (≥10 mut/Mb), and tumor-type-specific biomarkers per label.HER2 IHC 3+ or ISH amplified (ASCO/CAP guidelines).PD-L1 IC/TC scoring in NSCLC and UC; tumor-type-specific thresholds.HER2 expression (IHC/ISH per indication); higher systemic exposure associated with greater ILD incidence (FDA label §12.2).
Toxicology
Species
Cynomolgus monkey, Macaque, Mouse, RatRatCynomolgus monkey, MouseCynomolgus monkey, NHP, Rat, Hamster
Toxicology
Animal (cat.)
———NHP
Toxicology
Major finding
Immune-related AEsCardiotoxicity (LVEF decline, CHF risk especially with anthracyclines); infusion reactions; myelosuppression in combos.Immune-mediated pneumonitis, hepatitis, colitis, endocrinopathies.ILD-like lung findings at high exposure
Toxicology
CRS
N/AN/AN/AMinimal
Toxicology
NOAEL
———10 mg/kg
Clinical
Safety signal
Immune-related AEsCardiotoxicity (LVEF decline, CHF risk especially with anthracyclines); infusion reactions; myelosuppression in combos.Immune-mediated pneumonitis, hepatitis, colitis, endocrinopathies.ILD-like lung findings at high exposure
Clinical
Selected reported efficacy
———ORR 87%
Clinical
Reported ORR
———87% vs 81% (THP)
Clinical
Reported PFS
———40.7 months vs 26.9 months (THP)
Clinical
Reported OS
———Immature at the reported PFS analysis
Clinical
Result source
———FDA label 2026, Table 28 — DESTINY-Breast09 (NCT04784715)
Clinical
Program phase
APPROVEDAPPROVEDAPPROVEDAPPROVED
Clinical
Trial activity
No active/completed countsNo active/completed countsNo active/completed countsNo active/completed counts
Clinical
Trial ref
———NCT04784715
Preclinical
Animal (cat.)
—Mouse, In vitro—Human, Mouse, In vitro