[0.91, 1.15] Mutation-Positive 14.2 16.6 0.83 (n=22) (n=22) [0.41, 1.67] Mutation-Negative 6.4 6.0 1.02 (n=119) (n=134) [0.78, 1.33] PFS median mths All Subjects 2.2 2.7 1.04 (n=659) (n=657) [0.93, 1.18] 7.0 4.1 0.16 Mutation-Positive (n=19) (n=19) [0.05, 0.49] Mutation-Negative 1.7 2.6 1.24 (n=106) (n=123) [0.94, 1.64] ORR2 % All Subjects 9.1 7.6 1.5 (n=659) (n=657) [-1.5, 4.5] Mutation-Positive 42.1 21.1 21.0 (n=19) (n=19) [-8.2, 46.0] Mutation-Negative 6.6 9.8 -3.2 (n=106) (n=123) [-10.5, 4.4] 1 Cox proportional hazards model estimate of Iressa/docetaxel for PFS and OS and difference Iressa – docetaxel for ORR. 2 RECIST criteria. PFS: Progression-Free Survival, OS: Overall Survival, ORR: Overall Response Rate. Table 13: ISEL Efficacy Results Intent-to-Treat for OS, TTF and for ORR – – “Evaluable” Iressa po Placebo Hazard Ratio1 or Difference [95% CI] 250 mg daily OS median mths All Subjects 5.6 5.1 0.89 (n=1129) (n=563) [0.77, 1.02] Mutation-Positive NR 4.3 ND (n=21) (n=5) Mutation-Negative 3.7 5.9 1.16
[0.91, 1.15] Mutation-Positive 14.2 (n=22) 16.6 (n=22) 0.83 [0.41, 1.67] Mutation-Negative 6.4 (n=119) 6.0 (n=134) 1.02 [0.78, 1.33] PFS median mths All Subjects 2.2 (n=659) 2.7 (n=657) 1.04 [0.93, 1.18] Mutation-Positive 7.0 (n=19) 4.1 (n=19) 0.16 [0.05, 0.49] Mutation-Negative 1.7 (n=106) 2.6 (n=123) 1.24 [0.94, 1.64] ORR2 % All Subjects 9.1 (n=659) 7.6 (n=657) 1.5 [-1.5, 4.5] Mutation-Positive 42.1 (n=19) 21.1 (n=19) 21.0 [-8.2, 46.0] Mutation-Negative 6.6 (n=106) 9.8 (n=123) -3.2 [-10.5, 4.4] 1 Cox proportional hazards model estimate of Iressa/docetaxel for PFS and OS and difference Iressa – docetaxel for ORR. 2 RECIST criteria. PFS: Progression-Free Survival, OS: Overall Survival, ORR: Overall Response Rate. Table 13: ISEL – Efficacy Results – Intent-to-Treat for OS, TTF and “Evaluable” for ORR Iressa po 250 mg daily Placebo Hazard Ratio1 or Difference [95% CI] OS median mths All Subjects 5.6 (n=1129) 5.1 (n=563) 0.89 [0.77, 1.02] Mutation-Positive NR (n=21) 4.3 (n=5) ND Mutation-Negative 3.7 5.9 1.16
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