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항목
AntibodyCurated CorestalePhase 3
Mosunetuzumab (Mosunetuzumab)
Epizyme, Inc.·FRα
49 trials
Overview
Program
Mosunetuzumab
Overview
Company
Epizyme, Inc.
Overview
Modality
ANTIBODY
Overview
Target
FRα
Overview
Indication
Relapsed Hematologic Malignancy; Refractory Hematologic Malignancy
Overview
Phase
PHASE_3
Overview
Status
RECRUITING
Overview
Content status
Curated Core
Overview
Data Confidence
Data Confidence · High
Overview
Development Signal
Development Signal · Emerging
Overview
Approval status
Investigational
Positioning
Key differentiator
novel aspects of time toxicity, demonstrate clinically meaningful differences in time burden associated with BsAbs and emphas
Positioning
Known limitation
bypassing MHC presentation
MoA
Mechanism
, pharmacokinetic properties, and key clinical efficacy and safety data from the ELM-1 and ELM-2 trials, which supported its approval by the European Medicines Agency (EMA)
MoA
Biomarker
CD20 RO% was high
PK/PD
Species
Mouse, Human
PK/PD
Animal (cat.)
Human, Mouse
PK/PD
Experiment
pharmacokinetic
Toxicology
Species
Cynomolgus monkey, Mouse, Human
Toxicology
Animal (cat.)
NHP
Toxicology
Major finding
thrombocytopenia [see Adverse Reactions (6
Toxicology
CRS
39%
Clinical
Safety signal
thrombocytopenia [see Adverse Reactions (6
Clinical
Selected reported efficacy
ORR 87.5%
Clinical
Reported ORR
95.0%
Clinical
Reported PFS
NA
Clinical
Result source
ClinicalTrials.gov NCT03677141
Clinical
Program phase
PHASE_3
Clinical
Trial ref
NCT03677141