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API CSV23행 · 3개 프로그램

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항목
AntibodyCurated CoreFDAstaleApproved
glofitamab (Columvi, RO7082859, glofitamab-gxbm)
Roche / Genentech·CD20 × CD3
90 trials
AntibodyCurated CoreFDAstaleApproved
epcoritamab (Epkinly, GEN3013, Tepkinly, epcoritamab-bysp)
Genmab / AbbVie·CD20 × CD3
57 trials
AntibodyCurated CorestalePhase 3
Mosunetuzumab (Mosunetuzumab)
Epizyme, Inc.·FRα
49 trials
Overview
Program
Columvi (glofitamab)Epkinly (epcoritamab)Mosunetuzumab
Overview
Company
Roche / GenentechGenmab / AbbVieEpizyme, Inc.
Overview
Modality
ANTIBODYANTIBODYANTIBODY
Overview
Target
CD20 × CD3CD20 × CD3FRα
Overview
Indication
Relapsed or refractory diffuse large B-cell lymphomaRelapsed or refractory diffuse large B-cell lymphoma and follicular lymphomaRelapsed Hematologic Malignancy; Refractory Hematologic Malignancy
Overview
Phase
APPROVEDAPPROVEDPHASE_3
Overview
Status
APPROVEDAPPROVEDRECRUITING
Overview
Content status
Curated CoreCurated CoreCurated Core
Overview
Data Confidence
Editorial scope · Curated CoreEditorial scope · Curated CoreEditorial scope · Curated Core
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · Emerging
Overview
Approval status
FDA approvedFDA approvedInvestigational
Positioning
Key differentiator
Bivalent CD20 binding increases avidity; obinutuzumab pretreatment debulks circulating B cells to blunt first-dose CRS.Subcutaneous dosing gives slower Cmax and lower grade ≥3 CRS than IV engagers.novel aspects of time toxicity, demonstrate clinically meaningful differences in time burden associated with BsAbs and emphas
Positioning
Known limitation
CD20 loss after prior anti-CD20 therapy and T-cell exhaustion.CD20 antigen loss and exhausted effector T cells after multiple prior lines.bypassing MHC presentation
Positioning
Development positioning
3L+3L+—
MoA
Mechanism
Crosslinks CD20 on malignant B cells with CD3 on T cells; the 2:1 geometry stabilizes the synapse and drives T-cell activation and B-cell lysis.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., 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 expression; ctDNA clearance investigational.CD20 expression; ctDNA MRD investigational.CD20 RO% was high
Toxicology
Species
——Cynomolgus monkey
Toxicology
Animal (cat.)
——NHP
Toxicology
Major finding
Boxed warning for CRS. Neurologic events, infection, neutropenia, and tumor flare require monitoring.Boxed warning for CRS and ICANS. Injection-site reactions, neutropenia, and infection are common.thrombocytopenia [see Adverse Reactions (6
Toxicology
CRS
CRS ~63%, grade ≥3 ~4%CRS ~50%, grade ≥3 ~2.5%39%
Clinical
Safety signal
Boxed warning for CRS. Neurologic events, infection, neutropenia, and tumor flare require monitoring.Boxed warning for CRS and ICANS. Injection-site reactions, neutropenia, and infection are common.thrombocytopenia [see Adverse Reactions (6
Clinical
Program phase
APPROVEDAPPROVEDPHASE_3
Clinical
Trial activity
No active/completed countsNo active/completed counts—