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항목
ADCCurated CoreFDAstalePhase 3
Polatuzumab Vedotin (Polatuzumab Vedotin)
Roche / Genentech·FRα
91 trials
ADCCurated CoreFDAstaleApproved
mirvetuximab soravtansine-gynx (Elahere, IMGN853, mirvetuximab-soravtansine-gynx)
AbbVie / ImmunoGen·FRα (folate receptor alpha)
32 trials
ADCLimited DatastaleApproved
Sirolimus (Sirolimus)
Prevail Therapeutics·FRα
143 trials
Overview
Program
Polatuzumab VedotinElahere (mirvetuximab soravtansine-gynx)Sirolimus
Overview
Company
Roche / GenentechAbbVie / ImmunoGenPrevail Therapeutics
Overview
Modality
ADCADCADC
Overview
Target
FRαFRα (folate receptor alpha)FRα
Overview
Indication
Large B-Cell LymphomaFRα-positive platinum-resistant ovarian, fallopian tube, or primary peritoneal cancerParkinson Disease
Overview
Phase
PHASE_3APPROVEDAPPROVED
Overview
Status
RECRUITINGAPPROVEDRECRUITING
Overview
Content status
Curated CoreCurated CoreLimited Data
Overview
Data Confidence
Editorial scope · Curated CoreEditorial scope · Curated CoreEditorial scope · limited data
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · EstablishedDevelopment Signal · Established
Overview
Approval status
FDA approvedFDA approvedApproved (flag incomplete)
Positioning
Key differentiator
unique toxicities related to the antigen target, linker, or payload that have limited their developmentFRα is overexpressed in ovarian cancer but sparse in normal tissue, and the label requires IHC-confirmed expression.—
Positioning
Known limitation
resistance to POLA in vivoFRα downregulation and multidrug-resistance transporter upregulation.—
Positioning
Development positioning
—2L–4L platinum-resistant—
Technology
Payload
vedotin, rituximab, cyclophosphamide, doxorubicDM4 (maytansinoid, tubulin inhibitor)—
Technology
Linker
linker, or payload that have limited their developmentCleavable sulfo-SPDB disulfide, DAR ~3.5—
Technology
DAR
—DAR 3.5—
MoA
Mechanism
targeting specific cell surface antigens, many ADCs have also been associated with unique toxicities related to the antigenBinds 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.target synergy, effectively inhibits the PI3K pathway
MoA
Biomarker
CD20 expressionFRα IHC (VENTANA FOLR1 RxDx), PS2+ scoring with ≥75% of tumor cells staining.biomarkers or targeted therapies to guide management
Toxicology
Species
Cynomolgus monkey, Mouse, RatRat—
Toxicology
Animal (cat.)
Mouse, Rat, NHP——
Toxicology
Major finding
Hepatotoxicity: Monitor liver enzymes and bilirubinBoxed 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
Hepatotoxicity: Monitor liver enzymes and bilirubinBoxed 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
PHASE_3APPROVEDAPPROVED
Clinical
Trial activity
No active/completed countsNo active/completed countsNo active/completed counts
Clinical
Trial ref
—NCT04209855—
Preclinical
Animal (cat.)
Rat——