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API CSV26행 · 4개 프로그램

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항목
ADCCurated CoreFDAstalePhase 3
Polatuzumab Vedotin (Polatuzumab Vedotin)
Roche / Genentech·FRα
91 trials
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 CoreFDAstaleApproved
rituximab (Rituxan)
Roche / Genentech·CD20
1337 trials
Overview
Program
Polatuzumab VedotinColumvi (glofitamab)Epkinly (epcoritamab)Rituxan (rituximab)
Overview
Company
Roche / GenentechRoche / GenentechGenmab / AbbVieRoche / Genentech
Overview
Modality
ADCANTIBODYANTIBODYANTIBODY
Overview
Target
FRαCD20 × CD3CD20 × CD3CD20
Overview
Indication
Large B-Cell LymphomaRelapsed or refractory diffuse large B-cell lymphomaRelapsed or refractory diffuse large B-cell lymphoma and follicular lymphomaUS label: non-Hodgkin lymphoma, CLL, rheumatoid arthritis, GPA/MPA and pemphigus vulgaris; population-specific indications
Overview
Phase
PHASE_3APPROVEDAPPROVEDAPPROVED
Overview
Status
RECRUITINGAPPROVEDAPPROVEDAPPROVED
Overview
Content status
Curated CoreCurated CoreCurated CoreCurated Core
Overview
Data Confidence
Editorial scope · Curated CoreEditorial scope · Curated CoreEditorial scope · Curated CoreEditorial scope · Curated Core
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · Established
Overview
Approval status
FDA approvedFDA approvedFDA approvedFDA approved
Positioning
Key differentiator
unique toxicities related to the antigen target, linker, or payload that have limited their developmentBivalent 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 synthetic binding reagents to each of these mAbs
Positioning
Known limitation
resistance to POLA in vivoCD20 loss after prior anti-CD20 therapy and T-cell exhaustion.CD20 antigen loss and exhausted effector T cells after multiple prior lines.bypassing agents
Positioning
Development positioning
—3L+3L+—
Technology
Payload
vedotin, rituximab, cyclophosphamide, doxorubic———
Technology
Linker
linker, or payload that have limited their development———
MoA
Mechanism
targeting specific cell surface antigens, many ADCs have also been associated with unique toxicities related to the antigenCrosslinks 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.target cells via receptor
MoA
Biomarker
CD20 expressionCD20 expression; ctDNA clearance investigational.CD20 expression; ctDNA MRD investigational.CD20 mAbs: rituximab; ofatumumab; and obinutuzumab, were screened in high
Toxicology
Species
Cynomolgus monkey, Mouse, Rat———
Toxicology
Animal (cat.)
Mouse, Rat, NHP———
Toxicology
Major finding
Hepatotoxicity: Monitor liver enzymes and bilirubinBoxed 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.—
Toxicology
CRS
—CRS ~63%, grade ≥3 ~4%CRS ~50%, grade ≥3 ~2.5%—
Clinical
Safety signal
Hepatotoxicity: Monitor liver enzymes and bilirubinBoxed 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.—
Clinical
Program phase
PHASE_3APPROVEDAPPROVEDAPPROVED
Clinical
Trial activity
No active/completed countsNo active/completed countsNo active/completed countsNo active/completed counts
Preclinical
Animal (cat.)
Rat———