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항목
AntibodyCurated CoreFDAApproved
linvoseltamab (Lynozyfic, REGN5458, linvoseltamab-gcpt)
Regeneron·BCMA × CD3
24 trials·t½ IgG-like, supporting weekly then less frequent dosing
Overview
Program
Lynozyfic (linvoseltamab)
Overview
Company
Regeneron
Overview
Modality
ANTIBODY
Overview
Target
BCMA × CD3
Overview
Indication
Relapsed or refractory multiple myeloma after ≥4 prior lines including a PI, an IMiD, and an anti-CD38 antibody
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
Response-adapted schedule can stretch to q4w after a deep response, so the compare with Tecvayli is visit burden and CRS step-up, not the antigen.
Positioning
Known limitation
BCMA loss or mutation, T-cell exhaustion, and prior BCMA-directed therapy.
Positioning
Development positioning
Second approved BCMA engager after Tecvayli; dosing frequency is the operational split.
MoA
Mechanism
Binds BCMA on myeloma cells and CD3 on T cells, forming a cytolytic synapse that kills the plasma cell independent of native TCR specificity.
MoA
Biomarker
BCMA expression is not a companion diagnostic; soluble BCMA is exploratory.
PK/PD
Half-life
IgG-like, supporting weekly then less frequent dosing
PK/PD
Species
ORR, MRD, soluble BCMA
PK/PD
Animal (cat.)
Human
Toxicology
Major finding
Boxed warning for CRS and neurologic toxicity including ICANS. Neutropenia, infection, and hypogammaglobulinemia dominate later cycles.
Toxicology
CRS
CRS common, mostly grade 1–2 with step-up
Clinical
Safety signal
Boxed warning for CRS and neurologic toxicity including ICANS. Neutropenia, infection, and hypogammaglobulinemia dominate later cycles.
Clinical
Selected reported efficacy
ORR 70%
Clinical
Reported ORR
70%
Clinical
Result source
LINKER-MM1 (NCT03761108)
Clinical
Program phase
APPROVED
Clinical
Trial ref
NCT03761108