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현재 선택: 5 · Data Tier에서 열림

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API CSV33행 · 5개 프로그램

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항목
AntibodyCurated CoreFDAApproved
pembrolizumab (Keytruda)
Merck·PD-1
1669 trials·t½ 22 h
AntibodyCurated CoreFDAApproved
trastuzumab (Herceptin, Ogivri, Herzuma)
Roche / Genentech·HER2
1100 trials·t½ 4 h
AntibodyCurated CoreFDAApproved
atezolizumab (Tecentriq, MPDL3280A)
Roche / Genentech·PD-L1
693 trials·t½ 27 h
AntibodyCurated CoreFDAApproved
zanidatamab (Ziihera, ZW25, zanidatamab-hrii)
Jazz Pharmaceuticals / Zymeworks·HER2 (biparatopic)
35 trials·t½ ~7 days
AntibodyCurated CoreFDAApproved
tislelizumab (Tevimbra, BGB-A317, tislelizumab-jsgr)
BeOne Medicines·PD-1
213 trials·t½ ~20 days class range
Overview
Program
Keytruda (pembrolizumab)Herceptin (trastuzumab)Tecentriq (atezolizumab)Ziihera (zanidatamab)Tevimbra (tislelizumab)
Overview
Company
MerckRoche / GenentechRoche / GenentechJazz Pharmaceuticals / ZymeworksBeOne Medicines
Overview
Modality
ANTIBODYANTIBODYANTIBODYANTIBODYANTIBODY
Overview
Target
PD-1HER2PD-L1HER2 (biparatopic)PD-1
Overview
Indication
Multiple solid tumorsHER2+ breast cancer, HER2+ gastric/GEJ adenocarcinomaNSCLC, SCLC, HCC, TNBC, urothelial carcinoma, and othersFirst-line HER2-positive gastric, GEJ, or esophageal adenocarcinoma; previously treated HER2-positive biliary tract cancerEsophageal squamous cell carcinoma, gastric/GEJ adenocarcinoma, and first-line HER2-positive GEA with zanidatamab and chemotherapy
Overview
Phase
APPROVEDAPPROVEDAPPROVEDAPPROVEDAPPROVED
Overview
Status
APPROVEDAPPROVEDAPPROVEDAPPROVEDAPPROVED
Overview
Content status
Curated CoreCurated CoreCurated CoreCurated CoreCurated Core
Overview
Data Confidence
Data Confidence · HighData Confidence · HighData Confidence · HighData Confidence · HighData Confidence · High
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
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),Dual-epitope binding drives receptor clustering, faster internalization, and stronger signaling blockade than either monoclonal alone. In GEA the label splits IHC 3+ (chemo doublet) from IHC 3+ or 2+/ISH+ (chemo + Tevimbra).Not a Keytruda substitute. The 2026 GEA label is a HER2-selected triplet with zanidatamab, not a PD-L1-unselected 1L PD-1 row.
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 heterogeneity, PI3K pathway activation, and bypass RTK signaling.Antigen-presentation loss, alternate checkpoints, immunosuppressive TME.
Positioning
Development positioning
Global IO standardChallenges the ToGA trastuzumab-chemo backbone in 1L HER2+ GEA; still the only HER2 agent with a dedicated BTC indication.BeOne PD-1 with a China-heavy development history; the US HER2+ GEA triplet is the catalog reason to keep it next to Ziihera, not next to Keytruda's pan-tumor row.
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.Simultaneous binding of two non-overlapping HER2 epitopes crosslinks adjacent receptors, causing receptor clustering, internalization, and degradation alongside ADCC and complement activity.Binds PD-1 on T cells, blocking PD-L1/PD-L2 engagement and restoring antitumor T-cell activity. Fc silencing is intended to avoid macrophage-mediated T-cell clearance.
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.GEA: PATHWAY 4B5 IHC and VENTANA Dual ISH. IHC 3+ for chemo doublet; IHC 3+ or IHC 2+/ISH+ when Tevimbra is added. BTC: HER2 IHC 3+.PD-L1 and tumor type on older labels; HER2 IHC/ISH when given with Ziihera.
PK/PD
Half-life
22 h4 h27 h~7 days~20 days class range
PK/PD
Species
Mouse, Radiographic response, ctDNA clearance in some tumorsMouse, OS in metastatic BCMouse, HumanCynomolgus monkey, Human, OS and PFS in GEA, ORR and DOR in BTCOS/PFS, radiographic response
PK/PD
Animal (cat.)
Mouse, In vitroMouse, In vitroHuman, MouseHuman, NHP, In vitroHuman
PK/PD
Experiment
PDPharmacokineticPDpd
Toxicology
Species
Cynomolgus monkey, Macaque, Mouse, RatMouse, RatCynomolgus monkey, Mouse, HumanHuman
Toxicology
Major finding
Immune-related AEsCardiotoxicity (LVEF decline, CHF risk especially with anthracyclines); infusion reactions; myelosuppression in combos.Immune-mediated pneumonitis, hepatitis, colitis, endocrinopathies.Embryo-fetal toxicity warning. Diarrhea, infusion-related reactions, and left ventricular dysfunction require monitoring, as with the HER2 antibody class.Immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, and infusion-related reactions. Allogeneic transplant complications are labeled.
Toxicology
CRS
N/AN/AN/AN/AN/A
Clinical
Safety signal
Immune-related AEsCardiotoxicity (LVEF decline, CHF risk especially with anthracyclines); infusion reactions; myelosuppression in combos.Immune-mediated pneumonitis, hepatitis, colitis, endocrinopathies.Embryo-fetal toxicity warning. Diarrhea, infusion-related reactions, and left ventricular dysfunction require monitoring, as with the HER2 antibody class.Immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, and infusion-related reactions. Allogeneic transplant complications are labeled.
Clinical
Selected reported efficacy
ORR 38%ORR 91.2%ORR 52%ORR 87.1%
Clinical
Reported ORR
38%91.2%52%87.1%
Clinical
Reported PFS
1.7~5.5 mo31.5
Clinical
Reported OS
7.615.54
Clinical
Result source
ClinicalTrials.gov NCT02444741ClinicalTrials.gov NCT02149524ClinicalTrials.gov NCT04457778HERIZON-BTC-01 (NCT04466891)ClinicalTrials.gov NCT03209973
Clinical
Program phase
APPROVEDAPPROVEDAPPROVEDAPPROVEDAPPROVED
Clinical
Trial activity
No active/completed countsNo active/completed countsNo active/completed countsNo active/completed counts
Clinical
Trial ref
NCT02444741NCT02149524NCT04457778NCT04466891NCT03209973
Preclinical
Animal (cat.)
MouseUnknown