Progression-Free Survival

In DESTINY-Breast03, a head-to-head study vs T-DM1,

ENHERTU delivered groundbreaking progression-free survival in 2L to patients with HER2+ mBC1,a

Primary endpoint: Progression-free survival as assessed by BICR

Kaplan-Meier curve depicting mPFS based on BICR for ENHERTU vs T-DM1 Kaplan-Meier curve depicting mPFS based on BICR for ENHERTU vs T-DM1
72% reduction
  • in risk of disease progression or death vs T-DM1 (HR: 0.28; 95% Cl: 0.22, 0.37; P<0.0001)

aPFS (BICR) based on a median duration of follow-up of 15.5 months (range: 15.1-16.6) for ENHERTU and 13.9 months (range: 11.8-15.1) for T-DM1.2

Efficacy endpoint ENHERTU (n=261) T-DM1 (n=263)
Secondary: mPFS (investigator),
months (95% CI)2
25.1 (22.1, NE) 7.2 (6.8, 8.3)
HR: 0.26 (0.20, 0.35)
  • PFS (investigator) was not tested for statistical significance and not powered to show a difference between treatment arms

Similar mPFS results were observed in prespecified exploratory patient subgroups in the ENHERTU arm1,3

Forest plot depicting subgroup data for ENHERTU and T-DM1 mPFS (months)
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Forest plot depicting subgroup data for ENHERTU and T-DM1 mPFS (months)
 
  • Prespecified exploratory patient subgroups analyses were not powered to detect treatment effect differences between subgroups

Hazard ratios of 0.27-0.38 were observed in the patient subgroups assessed in DESTINY-Breast03

Downloadable Resource for You:

    Take a closer look at the DESTINY-Breast03
    efficacy and safety data

2L, second line; BICR, blind independent central review; CI, confidence interval; HER2, human epidermal growth factor receptor 2; HR, hazard ratio; HR-, hormone receptor negative; HR+, hormone receptor positive; mBC, metastatic breast cancer; mPFS, median progression-free survival; NE, not evaluable; NR, not reached; ORR, objective response rate; PFS, progression-free survival; T-DM1, ado-trastuzumab emtansine.