Table 3.

Secondary efficacy variable results

Variable, P600 arm/P900 arm (censoring rate, %)P600 (n = 47) median, months (95% CI)P900 (n = 45) median, months (95% CI)HR (95% CI)Log-rank P
TtTP (27.7/26.7)4.2 (2.7-5.6)4.6 (3.0-7.2)0.80 (0.49-1.30)0.364
PFS (27.7/24.4)4.2 (2.7-5.6)4.1 (3.0-6.2)0.82 (0.50-1.34)0.434
DR* (50.0/14.3)5.4 (2.9-?)7.4 (2.8-14.0)1.64 (0.45-5.89)0.447
TtTF (6.4/0.0)4.1 (2.7-4.5)3.3 (2.7-3.9)1.04 (0.68-1.59)0.849
OS* (61.7/66.7)(15.1-?)21.4 (17.5-22.2)0.87 (0.44-1.72)0.687
  • Abbreviations: PFS, progression-free survival; DR, duration of response; TtTF, time to treatment failure; OS, overall survival.

  • * The high censoring rate and partial confidence intervals precluded meaningful interpretation of the results.