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

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API CSV36행 · 2개 프로그램

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항목
ADCCurated CoreFDAstalePhase 3
Polatuzumab Vedotin (Polatuzumab Vedotin)
Roche / Genentech·FRα
91 trials·t½ 12.2 h
ADCCurated CoreFDAApproved
mirvetuximab soravtansine (Elahere, IMGN853, mirvetuximab-soravtansine-gynx)
AbbVie / ImmunoGen·FRα (folate receptor alpha)
32 trials·t½ ADC ~4.8 days
Overview
Program
Polatuzumab VedotinElahere (mirvetuximab soravtansine)
Overview
Company
Roche / GenentechAbbVie / ImmunoGen
Overview
Modality
ADCADC
Overview
Target
FRαFRα (folate receptor alpha)
Overview
Indication
Large B-Cell LymphomaFRα-positive platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer
Overview
Phase
PHASE_3APPROVED
Overview
Status
RECRUITINGAPPROVED
Overview
Content status
Curated CoreCurated Core
Overview
Data Confidence
Data Confidence · HighData Confidence · High
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · Established
Overview
Approval status
FDA approvedFDA approved
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
Only FRα-directed ADC approved in ovarian cancer.
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.
MoA
Biomarker
CD20 expressionFRα IHC (VENTANA FOLR1 RxDx), PS2+ scoring with ≥75% of tumor cells staining.
PK/PD
Half-life
12.2 hADC ~4.8 days
PK/PD
Species
RatCynomolgus monkey, Human, ORR, PFS, OS in FRα-high population
PK/PD
Animal (cat.)
Rat, In vitroHuman, NHP, In vitro
PK/PD
Experiment
pharmacokineticPD
Toxicology
Species
Cynomolgus monkey, Mouse, RatMouse, Rat, Human
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 100%ORR 52%
Clinical
Reported ORR
100.0%100%
Clinical
Reported PFS
13.49
Clinical
Result source
ClinicalTrials.gov NCT02611323ClinicalTrials.gov NCT02606305
Clinical
Program phase
PHASE_3APPROVED
Clinical
Trial activity
No active/completed countsNo active/completed counts
Clinical
Trial ref
NCT02611323NCT02606305
Preclinical
Animal (cat.)
Human, Mouse, Rat, In vitro