Table 2

Antitumor activity according to IRC and investigator in the full analysis set

ResponsePer IRC (N=156)Per investigator (N=156)
Best overall response, n (%)
 CR2 (1.3)2 (1.3)
 PR42 (26.9)35 (22.4)
 SD41 (26.3)47 (30.1)
 PD67 (42.9)67 (42.9)
 NA4 (2.6)5 (3.2)
ORR, n (%) (95% CI)44 (28.2) (21.3 to 36.0)37 (23.7) (17.3 to 31.2)
DCR, n (%) (95% CI)85 (54.5) (46.3 to 62.5)84 (53.8) (45.7 to 61.9)
DOR, median (95% CI)NR (9.5 to NR)NR (13.0 to NR)
TTR (weeks), median (range)8.3 (7.3–40.7)8.3 (7.1–56.0)
  • CR, complete response; DCR, disease control rate; DOR, duration of response; IRC, independent review committee; NA, not assessable; NR, not reached; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease; TTR, time to response.