Overall Survival (Final analysis of OS)** 0.68 0.0002 221 (54.4%) 168 (41.8%) [0.56;0.84] No. of patients with an 40.8 56.5 Median months Progression-Free Survival (investigator assessment) 0.65 <0.0001 [0.54;0.78] No. of patients with an event 250 (61.6%) 201 (50.0%) Median months 12.4 18.5 Objective Response Rate (ORR) No. of patients with an event 336 343 Responders*** 233 (69.3 %) 275 (80.2 %) Difference in 95% CI for ORR [64.1; 74.2] [75.6; 84.3] ORR: Complete response (CR) 14 (4.2 %) 19 (5.5 %) 10.8% 0.0011 Partial Response (PR) 219 (65.2 %) 256 (74.6 %) [4.2,17.5]% Stable disease (SD) 70 (20.8 %) 50 (14.6 %) Progressive disease (PD) 28 (8.3 %) 13 (3.8 %) Duration of Response ^# n= 233 275 Median 54.1 87.6 95% CI for Median [46;64] [71;106] * Primary progression-free survival analysis, cutoff date 13 May 2011 ** Final analysis of overall survival, cutoff date 11 February 2014 *** Patients with best overall response of confirmed CR or PR by RECIST. ^ Evaluated in patients with best Overall Response of CR or PR # Objective response rate and duration of response are based on IRF-assessed tumour assessments
Overall Survival (Final analysis of OS)** No. of patients with an Median months 221 (54.4%) 40.8 168 (41.8%) 56.5 0.68 [0.56;0.84] 0.0002 Progression-Free Survival (investigator assessment) No. of patients with an event Median months 250 (61.6%) 12.4 201 (50.0%) 18.5 0.65 [0.54;0.78] <0.0001 Objective Response Rate (ORR) No. of patients with an event Responders*** 95% CI for ORR Complete response (CR) Partial Response (PR) Stable disease (SD) Progressive disease (PD) 336 233 (69.3 %) [64.1; 74.2] 14 (4.2 %) 219 (65.2 %) 70 (20.8 %) 28 (8.3 %) 343 275 (80.2 %) [75.6; 84.3] 19 (5.5 %) 256 (74.6 %) 50 (14.6 %) 13 (3.8 %) Difference in ORR: 10.8% [4.2,17.5]% 0.0011 Duration of Response ^# n= Median 95% CI for Median 233 54.1 [46;64] 275 87.6 [71;106] * Primary progression-free survival analysis, cutoff date 13 May 2011 ** Final analysis of overall survival, cutoff date 11 February 2014 *** Patients with best overall response of confirmed CR or PR by RECIST. ^ Evaluated in patients with best Overall Response of CR or PR # Objective response rate and duration of response are based on IRF-assessed tumour assessments