Median Progression-Free Survival (PFS)

In DESTINY-Breast01,

ENHERTU monotherapy delivered 16.4 months mPFS in patients who progressed on 2L anti-HER2 therapy1

Probability of PFS for patients with HER2+ unresectable or mBC receiving ENHERTU 5.4 mg/kg (N=184)1,a

Kaplan-Meier curve depicting the probability of PFS in DESTINY-Breast01, showing 16.4 months median progression-free survival (N=184; 95% CI: 12.7, NR)  in patients receiving ENHERTU 5.4 mg/kg Kaplan-Meier curve depicting the probability of PFS in DESTINY-Breast01, showing 16.4 months median progression-free survival (N=184; 95% CI: 12.7, NR)  in patients receiving ENHERTU 5.4 mg/kg

aOf the 184 patients, 48 had progressive disease and 10 had died by 20 months; data for 126 patients were censored, as indicated by tick marks. Disease progression was assessed using modified RECIST v1.1. Dashed lines indicate the 95% CI. Based upon median duration of follow-up of 11.1 months at data cutoff date of August 1, 2019.1

18.1
months
median PFS
(95% CI: 6.7, 18.1)

in a prespecified exploratory subgroup analysis of 24 patients with stable brain metastases1

Median overall survival was not reached in DESTINY-Breast01 at median
follow-up of 11.1 months, data cutoff August 1, 20191

  • ENHERTU received accelerated approval from FDA based on tumor response rate and duration of response. FDA has not reviewed the PFS and OS data. Multiple confirmatory Phase 3 studies are underway2
DESTINY-Breast01
follow-up data

(June 2020 data cutoff)
Originally presented at SABCS 2020 with an encore at Miami Breast 2021

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2L, second line; CI, confidence interval; FDA, Food and Drug Administration; HER2, human epidermal growth factor receptor 2; mBC, metastatic breast cancer; mPFS, median progression-free survival; NR, not reached; OS, overall survival; RECIST, Response Evaluation Criteria in Solid Tumors.