Median Overall Survival (mOS)

Studied in DESTINY-Gastric01,

ENHERTU is the first and only HER2-directed treatment to surpass 1 year mOS in aGC following a trastuzumab-based regimen1-4

Significantly longer overall survival vs irinotecan or paclitaxel1,2,a

ENHERTU median overall survival ENHERTU median overall survival
  • 41% reduction in risk of death with ENHERTU vs irinotecan or paclitaxel
  • (HR=0.59; 95% CI: 0.39, 0.88; P=0.0097)1

aOS was evaluated following a statistically significant outcome of ORR. Interim OS analyses were conducted after all patients had tumor assessment at approximately 24 weeks or discontinued the study. At the time of analysis, 64 (51%) patients in the ENHERTU arm and 23 (37%) in the irinotecan or paclitaxel arm had their data censored, as noted by the tick marks. In the full analysis set of patients who received the study therapies (n=187), the two-sided P value of 0.01 crossed the O’Brien-Fleming boundary of significance (0.0202 on the basis of the number of deaths). Analysis was stratified by region. Data cutoff date November 8, 2019. Final OS analysis to be performed after approximately 133 deaths have occurred.2,5

  • DESTINY-Gastric01 studied 188 adult patients with HER2+ aGC who had received ≥2 prior lines of treatment, including a trastuzumab-based regimen
  • At the time of data cutoff, 49.6% of patients in the ENHERTU arm (n=62/126) had died vs 62.9% in the irinotecan or paclitaxel arm (n=39/62)5
  • The pre-specified analysis was based on the full analysis set (n=125, all randomized patients who received at least one dose of ENHERTU); data shown are based on the intent-to-treat analysis set (n=126, all randomized patients in the ENHERTU arm)5
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CI, confidence interval; HR, hazard ratio; HER2, human epidermal growth factor receptor 2.