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항목
ADCCurated CoreFDAstaleApproved
mirvetuximab soravtansine-gynx (Elahere, IMGN853, mirvetuximab-soravtansine-gynx)
AbbVie / ImmunoGen·FRα (folate receptor alpha)
32 trials
Overview
Program
Elahere (mirvetuximab soravtansine-gynx)
Overview
Company
AbbVie / ImmunoGen
Overview
Modality
ADC
Overview
Target
FRα (folate receptor alpha)
Overview
Indication
FRα-positive platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer
Overview
Phase
APPROVED
Overview
Status
APPROVED
Overview
Content status
Curated Core
Overview
Data Confidence
Editorial scope · Curated Core
Overview
Development Signal
Development Signal · Established
Overview
Approval status
FDA approved
Positioning
Key differentiator
FRα is overexpressed in ovarian cancer but sparse in normal tissue, and the label requires IHC-confirmed expression.
Positioning
Known limitation
FRα downregulation and multidrug-resistance transporter upregulation.
Positioning
Development positioning
2L–4L platinum-resistant
Technology
Payload
DM4 (maytansinoid, tubulin inhibitor)
Technology
Linker
Cleavable sulfo-SPDB disulfide, DAR ~3.5
Technology
DAR
DAR 3.5
MoA
Mechanism
Binds FRα, internalizes via receptor-mediated endocytosis, and releases DM4 after disulfide reduction; tubulin disruption causes mitotic arrest, with lipophilic S-methyl-DM4 giving bystander activity.
MoA
Biomarker
FRα IHC (VENTANA FOLR1 RxDx), PS2+ scoring with ≥75% of tumor cells staining.
Toxicology
Species
Rat
Toxicology
Major finding
Boxed warning for ocular toxicity — keratopathy, blurred vision, and dry eye. Peripheral neuropathy, nausea, and fatigue are also common.
Toxicology
CRS
N/A
Clinical
Safety signal
Boxed warning for ocular toxicity — keratopathy, blurred vision, and dry eye. Peripheral neuropathy, nausea, and fatigue are also common.
Clinical
Selected reported efficacy
ORR 42%
Clinical
Reported ORR
42% vs 16% (chemotherapy; rounded in NCI report)
Clinical
Reported PFS
5.6 months vs 4.0 months (chemotherapy)
Clinical
Reported OS
16.5 months vs 12.8 months (chemotherapy)
Clinical
Result source
NCI approval analysis 2024 — MIRASOL (NCT04209855)
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
NCT04209855