|
Response per investigator assessment in the intent-to-treat population (Stage IIIB–IVM1c disease)
|
|
DRR, n (%)
|
57 (19.3)
|
2 (1.4)
|
< 0.0001
|
17.9
|
12.0–23.1
|
|
CR, n (%)
|
50 (16.9)
|
1 (0.7)
|
–
|
–
|
–
|
|
PR, n (%)
|
43 (14.6)
|
8 (5.7)
|
–
|
–
|
–
|
|
ORR, % (95% CI)b
|
31.5 (26.3–37.2)
|
6.4 (3.0–11.8)
|
< 0.0001
|
25.1
|
17.4–31.7
|
|
SD, n (%)
|
132 (44.7)
|
71 (50.4)
|
–
|
–
|
–
|
|
DCR, n (%)
|
225 (76.3)
|
80 (56.7)
|
–
|
19.5
|
9.7–29.3
|
|
Progressive disease, n (%)
|
62 (21.0)
|
42 (29.8)
|
–
|
–
|
–
|
|
Not assessed, n (%)
|
8 (2.7)
|
19 (13.5)
|
–
|
–
|
–
|
|
Estimated OS probability in the intent-to-treat population (Stage IIIB–IVM1c disease), % (95% CI)
|
|
At 12 months
|
73.7 (68.3–78.4)
|
69.1 (60.6–76.2)
|
–
|
4.6
|
−4.7–13.8
|
|
At 24 months
|
49.8 (44.0–55.4)
|
40.3 (32.0–48.4)
|
–
|
9.5
|
−0.5–19.6
|
|
At 36 months
|
38.9 (33.3–44.4)
|
30.4 (22.9–38.3)
|
–
|
8.4
|
−1.2–18.0
|
|
At 48 months
|
34.5 (28.9–40.1)
|
23.9 (16.8–31.7)
|
–
|
10.6
|
1.2–20.0
|
|
At 60 months
|
33.4 (27.7–39.2)
|
NE
|
–
|
NE
|
NE
|
|
DRR, ORR, CR and DCR per investigator assessment according to disease stage
|
|
DRR, n/N (%)
|
|
IIIB/C
|
29/88 (33.0)
|
0/43 (0)
|
< 0.0001
|
33.0
|
19.1–43.9
|
|
IVM1a
|
18/75 (24.0)
|
0/43 (0)
|
0.0003
|
24.0
|
10.5–35.5
|
|
IIIB–IVM1a
|
47/163 (28.8)
|
0/86 (0)
|
< 0.0001
|
28.8
|
20.3–36.5
|
|
IVM1b
|
4/64 (6.3)
|
1/26 (3.8)
|
1.0000
|
2.4
|
−15.8–12.8
|
|
IVM1c
|
6/67 (9.0)
|
1/29 (3.4)
|
0.6710
|
5.5
|
−11.5–16.2
|
|
ORR, n/N (%)
|
|
IIIB/C
|
46/88 (52.3)
|
2/43 (4.7)
|
< 0.0001
|
47.6
|
31.1–59.0
|
|
IVM1a
|
29/75 (38.7)
|
2/43 (4.7)
|
< 0.0001
|
34.0
|
17.6–46.6
|
|
IIIB–IVM1a
|
75/163 (46.0)
|
4/86 (4.7)
|
< 0.0001
|
41.4
|
30.6–49.9
|
|
IVM1b
|
9/64 (14.1)
|
2/26 (7.7)
|
0.5002
|
6.4
|
−13.8–19.5
|
|
IVM1c
|
9/67 (13.4)
|
3/29 (10.3)
|
1.0000
|
3.1
|
−16.3–16.5
|
|
CR, n/N (%)
|
|
IIIB/C
|
31/88 (35.2)
|
0/43 (0)
|
–
|
–
|
–
|
|
IVM1a
|
15/75 (20.0)
|
1/43 (2.3)
|
–
|
–
|
–
|
|
IIIB–IVM1a
|
46/163 (28.2)
|
1/86 (1.2)
|
–
|
–
|
–
|
|
IVM1b
|
2/64 (3.1)
|
0/26 (0)
|
–
|
–
|
–
|
|
IVM1c
|
2/67 (3.0)
|
0/29 (0)
|
–
|
–
|
–
|
|
PR, n/N (%)
|
|
IIIB/C
|
15/88 (17.0)
|
2/43 (4.7)
|
–
|
–
|
–
|
|
IVM1a
|
14/75 (18.9)
|
1/43 (2.3)
|
–
|
–
|
–
|
|
IIIB–IVM1a
|
29/163 (17.8)
|
3/86 (3.5)
|
–
|
–
|
–
|
|
IVM1b
|
7/64 (10.9)
|
2/26 (7.7)
|
–
|
–
|
–
|
|
IVM1c
|
7/67 (10.4)
|
3/29 (10.3)
|
–
|
–
|
–
|
|
DCR, n/N (%)
|
|
IIIB/C
|
75/88 (85.2)
|
23/43 (53.5)
|
–
|
31.7
|
13.9–48.6
|
|
IVM1a
|
54/75 (72.0)
|
24/43 (55.8)
|
–
|
16.2
|
−2.7–34.6
|
|
IIIB–IVM1a
|
129/163 (79.1)
|
47/86 (54.7)
|
–
|
24.5
|
11.5–37.0
|
|
IVM1b
|
50/64 (78.1)
|
16/26 (61.5)
|
–
|
16.6
|
−4.9–39.3
|
|
IVM1c
|
46/67 (68.7)
|
17/29 (58.6)
|
–
|
10.0
|
−11.4–32.2
|
