DESTINY-Breast01 Trial

ENHERTU efficacy evaluated in DESTINY-Breast01

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

Study Design

Female patients with HER2+ unresectable and/or metastatic breast cancer who had received two or more prior anti-HER2 therapies. Part 1, established the recommended phase 2 dose (RP2D). Part 2, Evaluated safety and efficacy at RP2D. 184 patients received ENHERTU 5.5 mg/kg. Administered by IV infusion. Q3W until unacceptable toxicity or disease progression. Female patients with HER2+ unresectable and/or metastatic breast cancer who had received two or more prior anti-HER2 therapies. Part 1, established the recommended phase 2 dose (RP2D). Part 2, Evaluated safety and efficacy at RP2D. 184 patients received ENHERTU 5.5 mg/kg. Administered by IV infusion. Q3W until unacceptable toxicity or disease progression.
Primary endpoint1
  • Confirmed objective response rate (ORR), based on RECIST v1.1a
Key secondary endpoints1,2
  • Overall survival (OS), duration of response (DOR), progression-free survival (PFS), disease control rate (DCR), clinical benefit rate (CBR), and best percent change in the sum of diameters of measurable tumorsb
Selected exclusion criteria1
  • 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.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.4

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

100%Trastuzumab
66%Pertuzumab
100%Ado-trastuzumab emtansine (T-DM1)

Baseline patient demographics and disease characteristics1,4

DESTINY-Breast01
(N=184)
Median age
55 years (range: 28-96)
Female 100%
White 55%
Asian 38%
Black/African American 2%
ECOG performance status at baseline
0
1
55%
44%
Hormone receptor status Positive: 53%
Presence of visceral disease 92%
Bone metastases 29%
Brain metastases 13%
Sum of diameters of target lesionsd <5 cm: 42%, ≥5 cm: 50%
Prior cancer regimens in locally advanced/metastatic setting, median 5 (range: 2-17)

dNot evaluable by central review in 8% of patients.1

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