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항목
ADCCurated CoreFDAApproved
belantamab mafodotin (Blenrep, GSK2857916)
GSK·BCMA
78 trials·t½ 16.8 h
Overview
Program
Blenrep (belantamab mafodotin)
Overview
Company
GSK
Overview
Modality
ADC
Overview
Target
BCMA
Overview
Indication
Multiple myeloma
Overview
Phase
APPROVED
Overview
Status
DISCONTINUED
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
BCMA-targeted ADC with ocular AEs
Positioning
Known limitation
bypass this immune effector cell dependence, we developed a novel strategy using antibody-drug conjugates (ADCs)
Technology
Payload
MMAF
Technology
Linker
Non-cleavable
MoA
Mechanism
Belantamab mafodotin binds BCMA on plasma cells; afucosylated Fc enhances immune engagement while MMAF (microtubule inhibitor) payload is internalized and causes cell death.
MoA
Biomarker
BCMA expression on myeloma cells.
PK/PD
Half-life
16.8 h
PK/PD
Species
Cynomolgus monkey, Human, M-protein, corneal microcysts on ophthalmic exam
PK/PD
Animal (cat.)
Human, NHP
PK/PD
Experiment
Pd
Toxicology
Species
Cynomolgus monkey, Mouse, Rat, Human
Toxicology
Animal (cat.)
Human
Toxicology
Major finding
Ocular toxicity (keratopathy, blurred vision) in majority of patients; thrombocytopenia and infusion reactions.
Clinical
Safety signal
Ocular toxicity (keratopathy, blurred vision) in majority of patients; thrombocytopenia and infusion reactions.
Clinical
Selected reported efficacy
ORR 6%
Clinical
Reported ORR
6%
Clinical
Reported PFS
8.4
Clinical
Reported OS
19
Clinical
Result source
ClinicalTrials.gov NCT05986682
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
NCT05986682