|
Endpoint
|
Full analysis set
|
All patients enrolled
|
|---|
|
Investigator assessed (n = 89)
|
IRRC assessed (n = 89)
|
Investigator assessed (n = 102)
|
IRRC assessed (n = 102)
|
|---|
|
ORR
|
|
No. of patients
|
34
|
36
|
37
|
39
|
|
% of patients (95% CI)
|
38.2 (28.1 to 49.1)
|
40.4 (30.2 to 51.4)
|
36.3 (27.0 to 46.4)
|
38.2 (28.8 to 48.4)
|
|
DCR
|
|
No. of patients
|
49
|
53
|
54
|
57
|
|
% of patients (95% CI)
|
55.1 (44.1 to 65.6)
|
59.6 (48.6 to 69.8)
|
52.9 (42.8 to 62.9)
|
55.9 (45.7 to 65.7)
|
|
Objective response, n (%)
|
|
CR
|
8 (9.0)
|
13 (14.6)
|
8 (7.8)
|
14 (13.7)
|
|
PR
|
26 (29.2)
|
23 (25.8)
|
29 (28.4)
|
25 (24.5)
|
|
SD
|
15 (16.9)
|
17 (19.1)
|
17 (16.7)
|
18 (17.6)
|
|
PD
|
32 (36.0) #
|
28 (31.5)
|
37 (36.3)&
|
34 (33.3)
|
|
Not reported§
|
8 (9.0)
|
8 (9.0)
|
11 (10.8)
|
11 (10.8)
|
|
Median DOR, months
|
|
Median (95% CI)
|
4.0 (1.5 to NR)
|
11.4 (4.8 to NR)
|
4.2 (1.5 to NR)
|
7.4 (5.1 to NR)
|
|
% of patients ≥ 6 months (95% CI)
|
46.9 (29.1 to 62.8)
|
60.5 (41.8 to 74.8)
|
48.6 (31.4 to 63.7)
|
60.9 (43.0 to 74.7)
|
|
% of patients ≥ 12 months (95% CI)
|
46.9 (29.1 to 62.8)
|
48.5 (29.6 to 65.0)
|
40.8 (23.9 to 57.0)
|
43.8 (26.3 to 60.0)
|
- ORR, objective response rate; DCR, disease control rate; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; IRRC, independent radiological review committee; DOR, duration of response; CI, confidence interval; NR, not reached
- #21 patients had confirmed progressive disease; 11 patients with a first progressive disease and still under treatment
- &23 patients had confirmed progressive disease; 14 patients with a first progressive disease and still under treatment
- §Patients did not have post-baseline efficacy evaluation due to early termination or protocol violation
