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항목
AntibodyCurated CoreFDAApproved
nivolumab (Opdivo, BMS-936558)
Bristol Myers Squibb·PD-1
1280 trials·t½ 25 h
Overview
Program
Opdivo (nivolumab)
Overview
Company
Bristol Myers Squibb
Overview
Modality
ANTIBODY
Overview
Target
PD-1
Overview
Indication
Melanoma, NSCLC, RCC, HCC, MSI-H tumors, and others
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
novel approach to enhance antitumor therapy using aPD1 and aCTLA-4
Positioning
Known limitation
Loss of MHC-I/antigen presentation, β2M/JAK mutations, TIM-3/LAG-3 upregulation.
MoA
Mechanism
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-1 with slow dissociation and preferential binding in TME-mimicking low
PK/PD
Half-life
25 h
PK/PD
Species
Mouse, Objective response, duration of response, exploratory ctDNA clearance
PK/PD
Animal (cat.)
Mouse
PK/PD
Experiment
PD
Toxicology
Species
Cynomolgus monkey, Macaque, Mouse
Toxicology
Animal (cat.)
NHP
Toxicology
Major finding
Immune-related adverse reactions: pneumonitis, colitis, hepatitis, hypophysitis, thyroid disorders, nephritis, rash.
Toxicology
CRS
N/A (checkpoint inhibitor)
Clinical
Safety signal
Immune-related adverse reactions: pneumonitis, colitis, hepatitis, hypophysitis, thyroid disorders, nephritis, rash.
Clinical
Selected reported efficacy
ORR 100%
Clinical
Reported ORR
100%
Clinical
Result source
ClinicalTrials.gov NCT03267498
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
NCT03267498