Document Classification

Section Type: RESULTS

Text: The observed 6-month PFS rate was 43. 5 % (95 % confidence interval (CI), [28. 6-58. 4 %]) in arm A reaching the Fleming decision rules criteria to reject H0 and 26. 1 % (95 % CI [12. 9-39. 3 %]) in arm B. Objective response rates were 37 % (23-51 %) in arm A and 10 % (1-19 %) in arm B. Median PFS (5. 0 versus 3. 4 months, hazard ratio (HR) = 0. 59 [0. 38-0. 90]) and overall survival (11. 0 versus 8. 2 months, HR = 0. 71 [0. 46-1. 10]) were higher in arm A compared to arm B.