Table 2 Confirmed overall response by dose levels and by prior lines of therapy

All patients

Number of evaluable patients

n = 2

n = 21

n = 50

n = 73

 Complete response, n (%)

0

0

0

0

 Partial response, n (%)

0

0

10 (20.0)

10 (13.7)

 Stable disease^a, n (%)

0

12 (57.1)

22 (44.0)

34 (46.6)

 Progressive disease, n (%)

2 (100)

7 (33.3)

16 (32.0)

25 (34.2)

 Not evaluable, n (%)

0

2 (9.5)

2 (4.0)

4 (5.5)

 ORR, %(95% CI)

0 (0–84.2)

0 (0–16.1)

20.0 (10.0, 33.7)

13.7 (6.8, 23.8)

 DCR, %(95% CI)

0 (0–84.2)

57.1 (34.0–78.2)

64.0 (49.2–77.1)

60.3 (48.1–71.6)

Patients with 2 or more prior lines of systemic therapy

Number of evaluable patients

n = 0

n = 9

n = 35

n = 44

 Complete response, n (%)

NA

0

0

0

 Partial response, n (%)

NA

0

5 (14.3)

5 (11.4)

 Stable disease^a, n (%)

NA

4 (44.4)

15 (42.9)

19 (43.2)

 Progressive disease, n (%)

NA

4 (44.4)

13 (37.1)

17 (38.6)

 Not evaluable, n (%)

NA

1 (11.1)

2(5.7)

3 (6.8)

 ORR, % (95% CI)

NA

0 (0.0–33.6)

14.3 (4.8–30.3)

11.4 (3.8–24.6)

 DCR, % (95% CI)

NA

44.4 (13.7–78.8)

57.1 (39.4–73.7)

54.5 (38.9–69.6)