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현재 선택: 2 · 임상 갱신 필요 1 · Data Tier에서 열림

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항목
ADCCurated CoreFDAApproved
mirvetuximab soravtansine (Elahere, IMGN853, mirvetuximab-soravtansine-gynx)
AbbVie / ImmunoGen·FRα (folate receptor alpha)
32 trials·t½ ADC ~4.8 days
ADCLimited DatastalePhase 2
Gemcitabine Hydrochloride (Gemcitabine Hydrochloride)
K-Group, Beta, Inc., a wholly owne…·FRα
165 trials
Overview
Program
Elahere (mirvetuximab soravtansine)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
Data Confidence · HighData Confidence · Low
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
Only FRα-directed ADC approved in ovarian cancer.
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
PK/PD
Half-life
ADC ~4.8 days
PK/PD
Species
Cynomolgus monkey, Human, ORR, PFS, OS in FRα-high populationMouse
PK/PD
Animal (cat.)
Human, NHP, In vitroMouse, In vitro
PK/PD
Experiment
PDpharmacokinetic
Toxicology
Species
Mouse, Rat, HumanMouse
Toxicology
Animal (cat.)
Mouse, In vitro
Toxicology
Major finding
Boxed warning for ocular toxicity — keratopathy, blurred vision, and dry eye. Peripheral neuropathy, nausea, and fatigue are also common.From Parenteral to Oral Delivery: Facile Formulation of Oral Gemcitabine Nanospanlastics for Enhanced Bioavailability and Anticancer Activity in Murine Breast Cancer Model.. Gemcitabine hydrochloride (GEM) is a commonly used antineoplastic that is delivered only by intravenous infusion due to its limited oral bioavailability of 10%. The study aims to design and optimize novel Spanlastics (GEM-SLs)…
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.From Parenteral to Oral Delivery: Facile Formulation of Oral Gemcitabine Nanospanlastics for Enhanced Bioavailability and Anticancer Activity in Murine Breast Cancer Model.. Gemcitabine hydrochloride (GEM) is a commonly used antineoplastic that is delivered only by intravenous infusion due to its limited oral bioavailability of 10%. The study aims to design and optimize novel Spanlastics (GEM-SLs)…
Clinical
Selected reported efficacy
ORR 52%41.6%
Clinical
Reported ORR
100%
Clinical
Reported PFS
13.49
Clinical
Result source
ClinicalTrials.gov NCT02606305ClinicalTrials.gov NCT04222972
Clinical
Program phase
APPROVEDPHASE_2
Clinical
Trial activity
No active/completed countsNo active/completed counts
Clinical
Trial ref
NCT02606305NCT04222972
Preclinical
Animal (cat.)
Human, Mouse, Rat, In vitro