Efficacy

FASLODEX 500 mg significantly increased progression-free survival¹ (P=0.006): median progression-free survival was 6.5 months vs 5.4 months with FASLODEX 250 mg.

FASLODEX 500 mg Prolonged Progression-free Survival

Progression-Free Survival*: 20% Reduction in Risk of Progression^1,2

*Progression-free survival is defined as the time between randomization and the earliest of progression or death from any cause.

• There was no significant difference in overall survival (HR=0.84; 95% CI: 0.69-1.03) (P=0.091). The median overall survival was 25.1 months with FASLODEX 500 mg and 22.8 months with 250 mg²
  • Preplanned second survival analysis will occur when approximately 75% of patients have had an event²
• Objective response rates^† were not significantly different between FASLODEX 500 mg (13.8%) and 250 mg (14.6%) (HR=0.94; 95% CI: 0.57-1.55) (P=0.795)⁴
  • Only patients with measurable disease at baseline were analyzed; FASLODEX 500 mg (n=240), FASLODEX 250 mg (n=261)
  • Objective response rates in the full patient population were 9.1% and 10.2% for the FASLODEX 500 mg and 250 mg arms, respectively

^†Objective response rate was defined as the proportion of patients with complete response or partial response.

In this analysis, hazard ratio <1.00 indicates that FASLODEX 500 mg is associated with a longer time to progression than FASLODEX 250 mg.

• Predefined subgroups were studied for progression-free survival based on PgR status, visceral involvement, level of responsiveness to last endocrine therapy prior to FASLODEX, measurable disease, and age^2,4
• This representation was not designed to assess efficacy in individual subgroups but rather to visualize consistency with the "All patients" results

Progression-free Survival