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항목
AntibodyCurated CoreFDAApproved
pembrolizumab (Keytruda)
Merck·PD-1
1669 trials·t½ 22 h
Overview
Program
Keytruda (pembrolizumab)
Overview
Company
Merck
Overview
Modality
ANTIBODY
Overview
Target
PD-1
Overview
Indication
Multiple solid tumors
Overview
Phase
APPROVED
Overview
Status
APPROVED
Overview
Content status
Curated Core
Overview
Data Confidence
Data Confidence · High
Overview
Development Signal
Development Signal · Established
Overview
Approval status
FDA approved
Positioning
Key differentiator
Broad tumor-agnostic biomarker strategies (MSI-H, TMB)
Positioning
Known limitation
Loss of antigen presentation (β2M, JAK1/2), alternate checkpoints (TIM-3, LAG-3), and immunosuppressive TME.
Positioning
Development positioning
Global IO standard
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.
MoA
Biomarker
PD-L1 CPS/TPS (tumor-specific), MSI-H/dMMR, TMB-H (≥10 mut/Mb), and tumor-type-specific biomarkers per label.
PK/PD
Half-life
22 h
PK/PD
Species
Mouse, Radiographic response, ctDNA clearance in some tumors
PK/PD
Animal (cat.)
Mouse, In vitro
PK/PD
Experiment
PD
Toxicology
Species
Cynomolgus monkey, Macaque, Mouse, Rat
Toxicology
Major finding
Immune-related AEs
Toxicology
CRS
N/A
Clinical
Safety signal
Immune-related AEs
Clinical
Selected reported efficacy
ORR 38%
Clinical
Reported ORR
38%
Clinical
Result source
ClinicalTrials.gov NCT02444741
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
NCT02444741