HR positive and HR negative

Efficacy in Overall Study Population (HR+/ and HR–/HER2-low mBC)

ENHERTU nearly doubled mPFS vs chemotherapy in the overall study population (HR+ and HR–; N=557; secondary endpoint)1

KM curve depicting PFS with ENHERTU compared with chemotherapy in both HR+/ and HR–/HER2-low mBC KM curve depicting PFS with ENHERTU compared with chemotherapy in both HR+/ and HR–/HER2-low mBC

ENHERTU reduced the risk of disease progression or death by 50% vs chemotherapy (HR=0.50; 95% CI: 0.40, 0.63; P<0.0001)1

ENHERTU increased mOS by >6 months vs chemotherapy in the overall study population (HR+ and HR–; N=557; secondary endpoint)1

KM curve depicting OS with ENHERTU compared with chemotherapy in both HR+/ and HR–/HER2-low mBC KM curve depicting OS with ENHERTU compared with chemotherapy in both HR+/ and HR–/HER2-low mBC
  • Median follow-up: 18.4 months (95% CI: 17.7, 18.9)

36% reduction in the risk of death vs chemotherapy (HR=0.64; 95% CI: 0.49, 0.84; P=0.001)1

More than tripled ORR vs chemotherapy1,2

Nearly half of patients receiving ENHERTU (HR+ and HR–) had a confirmed objective response (N=557; secondary endpoint)

ENHERTU
(n=373)
Chemotherapy
(n=184)
Confirmed ORR (BICR) 52.3% (n=195; 95% CI: 47.1, 57.4) 16.3% (n=30; 95% CI: 11.3, 22.5)
CR 3.5% (n=13) 1.1% (n=2)
mDOR (BICR) 10.7 months (95% CI: 8.5, 13.2) 6.8 months (95% CI: 6.0, 9.9)
ORR and DOR were not tested for statistical significance, and were not powered to show differences between treatment arms.

Survival benefit observed in the overall study population (HR+ and HR–)1,3

Summary of DESTINY-Breast04 efficacy results by patient population1-3,a,b

Table depicting summary of DESTINY-Breast04 efficacy results by patient population
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Table depicting summary of DESTINY-Breast04 efficacy results by patient population
 

aFor the primary and secondary endpoints, the hormone receptor status is based on data collected using the interactive web/voice response system at the time of randomization, which includes mis-stratified patients.1

b For other endpoints, hormone receptor status is based on data from the electronic data capture corrected for mis-stratification.1

  • The HR– cohort was an exploratory population. The data are descriptive and were not tested for statistical significance, nor powered to show a difference between treatment arms
  • ORR and mDOR were not tested for statistical significance, and were not powered to show differences between treatment arms
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CI, confidence interval; CR, complete response; HER2, human epidermal growth factor receptor 2; HR, hazard ratio; HR+, hormone receptor-positive; HR–, hormone receptor-negative; mBC, metastatic breast cancer; mDOR, median duration of response; mOS, median overall survival; mPFS, median progression-free survival; NE, not evaluable; ORR, objective response rate.