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항목
ADCCurated CoreFDAApproved
ado-trastuzumab emtansine (Kadcyla, T-DM1, ado-trastuzumab emtansine / T-DM1)
Roche / Genentech·HER2
178 trials·t½ 4 h
Overview
Program
Kadcyla (ado-trastuzumab emtansine / T-DM1)
Overview
Company
Roche / Genentech
Overview
Modality
ADC
Overview
Target
HER2
Overview
Indication
HER2+ breast cancer
Overview
Phase
APPROVED
Overview
Status
APPROVED
Overview
Content status
Curated Core
Overview
Data Confidence
Data Confidence · High
Overview
Development Signal
Development Signal · Established
Overview
Approval status
FDA approved
Positioning
Key differentiator
Stable linker, DAR ~3.5
Positioning
Known limitation
HER2 downregulation, lysosomal trapping, and efflux; superseded in 2L HER2+ mBC by trastuzumab deruxtecan (DESTINY-Breast03).
Positioning
Development positioning
Established SOC before Enhertu head-to-head
Technology
Payload
MMAE (maytansinoid)
Technology
Linker
Non-cleavable SMCC
MoA
Mechanism
Ado-trastuzumab emtansine (T-DM1) binds HER2 on tumor cells, is internalized, and MMAE is released after lysosomal degradation of the antibody in the non-cleavable SMCC linker system. MMAE disrupts microtubules, causing G2/M arrest and apoptosis.
MoA
Biomarker
HER2 overexpression/amplification (IHC 3+ or ISH+ per label).
PK/PD
Half-life
4 h
PK/PD
Species
Mouse, Tumor response
PK/PD
Animal (cat.)
Mouse, In vitro
PK/PD
Experiment
Pharmacokinetic
Toxicology
Species
Cynomolgus monkey, Mouse, Rat
Toxicology
Animal (cat.)
NHP
Toxicology
Major finding
Thrombocytopenia, hepatotoxicity
Toxicology
CRS
Minimal
Clinical
Safety signal
Thrombocytopenia, hepatotoxicity
Clinical
Selected reported efficacy
ORR 43.6%
Clinical
Reported ORR
43.6% (EMILIA)
Clinical
Reported PFS
9.6 mo
Clinical
Reported OS
30.9 mo
Clinical
Result source
EMILIA
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
EMILIA
Preclinical
Animal (cat.)
In vitro