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항목
AntibodyCurated CoreFDAApproved
tarlatamab (Imdelltra, AMG 757, tarlatamab-dlle)
Amgen·DLL3 × CD3
39 trials·t½ ~11 days (Fc-extended)
Overview
Program
Imdelltra (tarlatamab)
Overview
Company
Amgen
Overview
Modality
ANTIBODY
Overview
Target
DLL3 × CD3
Overview
Indication
Extensive-stage small cell lung cancer after platinum-based chemotherapy
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
DLL3 is expressed on ~85–95% of SCLC tumors but almost absent from normal tissue, which is rare for a solid-tumor engager target.
Positioning
Known limitation
Neuroendocrine-to-non-neuroendocrine plasticity with DLL3 loss; T-cell exhaustion.
Positioning
Development positioning
Only approved DLL3-directed therapy after the failure of rovalpituzumab tesirine.
MoA
Mechanism
Binds DLL3 on SCLC cells and CD3 on T cells, forcing a cytolytic synapse that kills tumor cells regardless of native TCR specificity.
MoA
Biomarker
DLL3 expression by IHC is not required in the label but tracks with the biology.
PK/PD
Half-life
~11 days (Fc-extended)
PK/PD
Species
Cynomolgus monkey, Cytokine kinetics, T-cell margination, radiographic response
PK/PD
Animal (cat.)
Human, NHP, In vitro
PK/PD
Experiment
pharmacokinetic
Toxicology
Species
Mouse
Toxicology
Major finding
Boxed warning for CRS and neurologic toxicity including ICANS. Cytopenia and fatigue are common; step-up dosing with monitoring is mandatory.
Toxicology
CRS
CRS ~51–55%, mostly grade 1–2
Clinical
Safety signal
Boxed warning for CRS and neurologic toxicity including ICANS. Cytopenia and fatigue are common; step-up dosing with monitoring is mandatory.
Clinical
Selected reported efficacy
ORR 57.1%
Clinical
Reported ORR
57.1%
Clinical
Reported PFS
6.5
Clinical
Reported OS
NA
Clinical
Result source
ClinicalTrials.gov NCT04885998
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
NCT04885998
Preclinical
Animal (cat.)
Mouse, In vitro