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항목
ADCCurated CoreFDAstaleApproved
mirvetuximab soravtansine-gynx (Elahere, IMGN853, mirvetuximab-soravtansine-gynx)
AbbVie / ImmunoGen·FRα (folate receptor alpha)
32 trials
ADCLimited DatastalePhase 2
Gemcitabine Hydrochloride (Gemcitabine Hydrochloride)
K-Group, Beta, Inc., a wholly owne…·FRα
165 trials
Overview
Program
Elahere (mirvetuximab soravtansine-gynx)Gemcitabine Hydrochloride
Overview
Company
AbbVie / ImmunoGenK-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Overview
Modality
ADCADC
Overview
Target
FRα (folate receptor alpha)FRα
Overview
Indication
FRα-positive platinum-resistant ovarian, fallopian tube, or primary peritoneal cancerFallopian Tube Carcinosarcoma; Fallopian Tube Clear Cell Adenocarcinoma
Overview
Phase
APPROVEDPHASE_2
Overview
Status
APPROVEDACTIVE
Overview
Content status
Curated CoreLimited Data
Overview
Data Confidence
Editorial scope · Curated CoreEditorial scope · limited data
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · Emerging
Overview
Approval status
FDA approvedInvestigational
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 ~3.5linker-payload technologies
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.of ProAgio, which includes reducing hypoxia and modulating TME
MoA
Biomarker
FRα IHC (VENTANA FOLR1 RxDx), PS2+ scoring with ≥75% of tumor cells staining.HER2 expression
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
APPROVEDPHASE_2
Clinical
Trial activity
No active/completed countsNo active/completed counts
Clinical
Trial ref
NCT04209855—