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Table 2 Results of Efficacy Endpoints

From: XM02 is superior to placebo and equivalent to Neupogen™ in reducing the duration of severe neutropenia and the incidence of febrile neutropenia in cycle 1 in breast cancer patients receiving docetaxel/doxorubicin chemotherapy

Treatment group XM02 Neupogen™ Placebo/XM02*
Full analysis set [n] (n = 140) (n = 136) 72
Mean DSN [days]    
   Cycle 1 1.1 1.1 3.8
   ANCOVA [CI]# 0.028 [-0.261, 0.316]   
   Cycle 4 0.7 0.7 0.6
Mean ANC nadir [10 9 /L]    
   Cycle 1 0.7 0.7 0.2
   ANCOVA [CI]# -0.001 [-0.190, 0.189]   
   Cycle 4 1.0 1.0 1.1
Mean time to ANC recovery [days]    
   Cycle 1 8.0 7.8 14.0
   ANCOVA [CI]# 0.207 [-0.425, 0.838]   
   Cycle 4 7.6 7.1 7.2
Incidence of FN [%]+    
   Cycle 1 12.1 12.5 36.1
   Across all cycles 20.7 22.1 41.7
  1. Abbreviations: DSN: duration of severe neutropenia; ANC: absolute neutrophil count; FN: febrile neutropenia; ANCOVA: analysis of covariance, CI: confidence interval.
  2. * Patients in this group received placebo in cycle 1 and XM02 afterwards (including in cycle 4).
  3. # ANCOVA estimate and 2-sided 95% confidence interval for difference XM02 – Filgrastim in cycle 1.
  4. + Observed or protocol defined FN.