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항목
AntibodyCurated CoreFDAstaleApproved
tarlatamab (Imdelltra, AMG 757, tarlatamab-dlle)
Amgen·DLL3 × CD3
39 trials
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
Editorial scope · Curated Core
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
2L+
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.
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
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts