Table 3

Clinical activity

Part IIPart III
N=12
Pooled Part II and III
N=10
(Efficacy population)
N=22
(Efficacy population)
Response rateN (%)N (%)N (%)
Complete response1 (10)01 (4.5)
Partial response4 (40)6 (50)10 (46)
Stable disease (SD)5 (50)6 (42)10 (46)
Overall response rate (ORR)5 (50)6 (50)11 (50)
Long duration SD*5 (50)3 (25)8 (36.4)*
ORR at 3.3×10123 (50)1 (17)4 (33.3)
ORR at 1.0×10132 (50)5 (83)7 (70)
Survival analysesMedian in months (95% CI)Median in months (95% CI)Median in months (95% CI)
Progression-free survival (PFS)9.94 (2.83 to 19.85)6.69 (1.6 to 14.4)7.22 (1.6 to 19.85)
Overall survival11.0 (5.03 to 48.43)13.47 (2.6 to 29.6+)13.35 (2.6 to 48.43)
  • *(>1 year).