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항목
AntibodyCurated CoreFDAApproved
nivolumab (Opdivo, BMS-936558)
Bristol Myers Squibb·PD-1
1280 trials·t½ 25 h
CGTCurated CoreFDAApproved
lifileucel (Amtagvi, LN-144, tumor infiltrating lymphocyte)
Iovance Biotherapeutics·Polyclonal tumor neoantigens (TIL)
47 trials·t½ Cell persistence, not plasma pharmacokinetics
Overview
Program
Opdivo (nivolumab)Amtagvi (lifileucel)
Overview
Company
Bristol Myers SquibbIovance Biotherapeutics
Overview
Modality
ANTIBODYCGT
Overview
Target
PD-1Polyclonal tumor neoantigens (TIL)
Overview
Indication
Melanoma, NSCLC, RCC, HCC, MSI-H tumors, and othersUnresectable or metastatic melanoma after PD-1 blockade
Overview
Phase
APPROVEDAPPROVED
Overview
Status
APPROVEDAPPROVED
Overview
Content status
Curated CoreCurated Core
Overview
Data Confidence
Data Confidence · HighData Confidence · High
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · Established
Overview
Approval status
FDA approvedFDA approved
Positioning
Key differentiator
novel approach to enhance antitumor therapy using aPD1 and aCTLA-4Polyclonal recognition of private neoantigens instead of one engineered receptor, so it does not depend on a single shared target.
Positioning
Known limitation
Loss of MHC-I/antigen presentation, β2M/JAK mutations, TIM-3/LAG-3 upregulation.Antigen presentation loss (B2M/HLA), TIL exhaustion, and a hostile tumor microenvironment.
Positioning
Development positioning
Only approved TIL product; opens the solid-tumor cell-therapy category.
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.Autologous TILs already primed against the patient's tumor are expanded to therapeutic numbers, reinfused after lymphodepletion to clear regulatory cells and cytokine sinks, then supported with IL-2.
MoA
Biomarker
PD-1 with slow dissociation and preferential binding in TME-mimicking lowTumor mutational burden and baseline tumor burden correlate with response; no required companion diagnostic.
PK/PD
Half-life
25 hCell persistence, not plasma pharmacokinetics
PK/PD
Species
Mouse, Objective response, duration of response, exploratory ctDNA clearanceTIL persistence in blood and tumor, radiographic response duration
PK/PD
Animal (cat.)
MouseHuman
PK/PD
Experiment
PDPD
Toxicology
Species
Cynomolgus monkey, Macaque, MouseMouse
Toxicology
Animal (cat.)
NHP
Toxicology
Major finding
Immune-related adverse reactions: pneumonitis, colitis, hepatitis, hypophysitis, thyroid disorders, nephritis, rash.Boxed warning for treatment-related mortality, prolonged severe cytopenia, severe infection, cardiopulmonary and renal impairment, and internal hemorrhage. Most toxicity comes from lymphodepletion and IL-2, not the TILs themselves.
Toxicology
CRS
N/A (checkpoint inhibitor)Uncommon compared with CAR-T
Clinical
Safety signal
Immune-related adverse reactions: pneumonitis, colitis, hepatitis, hypophysitis, thyroid disorders, nephritis, rash.Boxed warning for treatment-related mortality, prolonged severe cytopenia, severe infection, cardiopulmonary and renal impairment, and internal hemorrhage. Most toxicity comes from lymphodepletion and IL-2, not the TILs themselves.
Clinical
Selected reported efficacy
ORR 100%ORR 83.33%
Clinical
Reported ORR
100%83.33%
Clinical
Reported OS
12
Clinical
Result source
ClinicalTrials.gov NCT03267498ClinicalTrials.gov NCT02111863
Clinical
Program phase
APPROVEDAPPROVED
Clinical
Trial activity
No active/completed countsNo active/completed counts
Clinical
Trial ref
NCT03267498NCT02111863
Preclinical
Animal (cat.)
Mouse
Opdivo (nivolumab) vs Amtagvi (lifileucel) 비교 | 바이오정보모아