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항목
AntibodyCurated CoreFDAApproved
epcoritamab (Epkinly, GEN3013, Tepkinly, epcoritamab-bysp)
Genmab / AbbVie·CD20 × CD3
57 trials·t½ ~3 weeks at steady state
Overview
Program
Epkinly (epcoritamab)
Overview
Company
Genmab / AbbVie
Overview
Modality
ANTIBODY
Overview
Target
CD20 × CD3
Overview
Indication
Relapsed or refractory diffuse large B-cell lymphoma and follicular lymphoma
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
Subcutaneous dosing gives slower Cmax and lower grade ≥3 CRS than IV engagers.
Positioning
Known limitation
CD20 antigen loss and exhausted effector T cells after multiple prior lines.
Positioning
Development positioning
Main SC alternative to Columvi, with continuous rather than fixed duration.
MoA
Mechanism
Bispecific binding of CD20 on B cells and CD3 on T cells creates a cytolytic synapse; the silenced Fc prevents Fcγ-receptor-driven off-target activation.
MoA
Biomarker
CD20 expression; ctDNA MRD investigational.
PK/PD
Half-life
~3 weeks at steady state
PK/PD
Species
Cynomolgus monkey, Peripheral B-cell depletion, cytokine kinetics, PET response
PK/PD
Animal (cat.)
Human, NHP, In vitro
PK/PD
Experiment
pharmacokinetic
Toxicology
Species
Cynomolgus monkey
Toxicology
Major finding
Boxed warning for CRS and ICANS. Injection-site reactions, neutropenia, and infection are common.
Toxicology
CRS
CRS ~50%, grade ≥3 ~2.5%
Clinical
Safety signal
Boxed warning for CRS and ICANS. Injection-site reactions, neutropenia, and infection are common.
Clinical
Selected reported efficacy
ORR 61%
Clinical
Reported ORR
61% (DLBCL)
Clinical
Result source
EPCORE NHL-1 (NCT03625037)
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
NCT03625037
Preclinical
Animal (cat.)
Human, NHP, Monkey, In vitro