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API CSV22행 · 2개 프로그램

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항목
AntibodyCurated CoreFDAstaleApproved
pembrolizumab (Keytruda)
Merck·PD-1
1669 trials
AntibodyCurated CoreFDAstaleApproved
nivolumab (Opdivo, BMS-936558)
Bristol Myers Squibb·PD-1
1280 trials
Overview
Program
Keytruda (pembrolizumab)Opdivo (nivolumab)
Overview
Company
MerckBristol Myers Squibb
Overview
Modality
ANTIBODYANTIBODY
Overview
Target
PD-1PD-1
Overview
Indication
Multiple solid tumorsMelanoma, NSCLC, RCC, HCC, MSI-H tumors, and others
Overview
Phase
APPROVEDAPPROVED
Overview
Status
APPROVEDAPPROVED
Overview
Content status
Curated CoreCurated Core
Overview
Data Confidence
Editorial scope · Curated CoreEditorial scope · Curated Core
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · Established
Overview
Approval status
FDA approvedFDA approved
Positioning
Key differentiator
Broad tumor-agnostic biomarker strategies (MSI-H, TMB)novel approach to enhance antitumor therapy using aPD1 and aCTLA-4
Positioning
Known limitation
Loss of antigen presentation (β2M, JAK1/2), alternate checkpoints (TIM-3, LAG-3), and immunosuppressive TME.Loss of MHC-I/antigen presentation, β2M/JAK mutations, TIM-3/LAG-3 upregulation.
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.Nivolumab is a human IgG4 monoclonal antibody that binds the PD-1 receptor on T cells, blocking interaction with PD-L1 and PD-L2 and releasing PD-1 pathway-mediated inhibition of antitumor immune responses.
MoA
Biomarker
PD-L1 CPS/TPS (tumor-specific), MSI-H/dMMR, TMB-H (≥10 mut/Mb), and tumor-type-specific biomarkers per label.PD-1 with slow dissociation and preferential binding in TME-mimicking low
Toxicology
Species
Cynomolgus monkey, Macaque, Mouse, RatCynomolgus monkey, Macaque, Mouse
Toxicology
Animal (cat.)
—NHP
Toxicology
Major finding
Immune-related AEsImmune-related adverse reactions: pneumonitis, colitis, hepatitis, hypophysitis, thyroid disorders, nephritis, rash.
Toxicology
CRS
N/AN/A (checkpoint inhibitor)
Clinical
Safety signal
Immune-related AEsImmune-related adverse reactions: pneumonitis, colitis, hepatitis, hypophysitis, thyroid disorders, nephritis, rash.
Clinical
Program phase
APPROVEDAPPROVED
Clinical
Trial activity
No active/completed countsNo active/completed counts