ENHERTU Clinical Study

ENHERTU efficacy evaluated in DESTINY-Breast01

A Phase 2, multicenter, single-arm trial1,2

Study Design

Selected exclusion criteria 1
  • History of treated interstitial lung disease (ILD) or ILD at screening
  • History of clinically significant cardiac disease
  • Active brain metastasesc
  • ECOG performance status >1
Multiple confirmatory Phase 3 studies are underway3

aORR defined as CR + PR per RECIST v1.1 in the ITT population as evaluated by independent central review. ORR 95% CI calculated using Clopper-Pearson method.1

b DCR=CR+PR+SD; CBR=CR+PR+SD>6 months.2

cPatients with brain metastases that were untreated, symptomatic, or required therapy within 2 months of randomization were excluded. A prespecified number of patients with inactive brain metastases were enrolled.2

ECOG, Eastern Cooperative Oncology Group; Q3W, every 3 weeks; SD, stable disease.

In DESTINY-Breast01,

All trial participants had previously received two or more HER2-targeted therapies1

emtansine (T-DM1)
Patients had received a median of 5 (range: 2-17) prior cancer regimens
in the locally advanced/metastatic setting1

Baseline patient demographics and disease characteristics1,4

Age Median
55 years (range: 28-96)
Female 100%
White 55%
Asian 38%
Black/African American 2%
ECOG performance status at baseline
Hormone receptor status positive: 53%
Presence of visceral disease 92%
Brone metastases 29%
Brian metastases 13%
some of diameters of target lesionsd <5 cm 42% ≥5 cm: 50%

dNot evaluable by central review in 8% of patients.

Review the ENHERTU efficacy and safety data
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