Table 2.
Survival outcomes according to tumor type and HER2 IHC status by the local or central test result used for study enrollment
| HER2 status by test for study enrollment | PFS | OS | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Investigator assessment | ICR | ||||||||||||
| Median, months (95% CI) | 6 months, % (95% CI) |
12 months, % (95% CI) | 18 months, % (95% CI) | Median, months (95% CI) | 6 months, % (95% CI) |
12 months, % (95% CI) | 18 months, % (95% CI) |
Median, months (95% CI) | 6 months, % (95% CI) |
12 months, % (95% CI) | 18 months, % (95% CI) | ||
| All patients |
IHC 3+ (n = 111) |
9.7 (7.0, 12.5) |
65.6 (55.8, 73.8) |
44.0 (34.4, 53.3) |
31.2 (22.4, 40.4) |
10.1 (7.0, 14.2) |
66.4 (56.6, 74.5) |
47.3 (37.2, 56.7) |
36.9 (26.9, 46.8) |
17.7 (12.8, 21.8) |
77.1 (68.1, 83.9) |
63.3 (53.5, 71.6) |
49.9 (40.1, 58.9) |
|
IHC 2+ (n = 151) |
5.1 (4.1, 6.0) |
43.2 (35.0, 51.2) |
19.2 (13.1, 26.3) |
13.0 (7.9, 19.6) |
5.6 (4.2, 7.0) |
47.4 (38.6, 55.7) |
23.7 (16.1, 32.1) |
18.4 (11.4, 26.7) |
12.0 (9.6, 13.5) |
71.9 (63.9, 78.4) |
50.6 (42.2, 58.3) |
31.0 (23.6, 38.7) |
|
| Endometrial cancer |
IHC 3+ (n = 16) |
NE (4.5, NE) |
74.5 (45.4, 89.6) |
60.9 (32.7, 80.3) |
54.2 (27.1, 75.0) |
NE (3.9, NE) |
74.5 (45.4, 89.6) |
67.0 (37.7, 84.9) |
59.6 (30.8, 79.6) |
26.0 (4.5, NE) |
75.0 (46.3, 89.8) |
75.0 (46.3, 89.8) |
68.8 (40.5, 85.6) |
|
IHC 2+ (n = 24) |
11.0 (6.0, 19.5) |
73.9 (50.7, 87.4) |
41.0 (20.7, 60.4) |
30.8 (13.0, 50.6) |
11.8 (6.0, 20.3) |
73.9 (50.7, 87.4) |
45.5 (22.5, 66.0) |
32.5 (12.6, 54.3) |
20.3 (8.1, NE) |
91.3 (69.5, 97.8) |
65.2 (42.3, 80.8) |
52.2 (30.5, 70.0) |
|
| Cervical cancer |
IHC 3+ (n = 10) |
NE (3.9, NE) |
90.0 (47.3, 98.5) |
68.6 (30.5, 88.7) |
51.4 (14.3, 79.6) |
NE (2.9, NE) |
90.0 (47.3, 98.5) |
77.1 (34.5, 93.9) |
57.9 (15.3, 85.2) |
NE (3.9, NE) |
90.0 (47.3, 98.5) |
90.0 (47.3, 98.5) |
90.0 (47.3, 98.5) |
|
IHC 2+ (n = 25) |
4.6 (1.4, 8.1) |
33.3 (15.9, 51.9) |
14.3 (2.9, 34.4) |
0.0 (NE, NE) |
4.6 (2.7, 8.3) |
36.1 (16.7, 56.0) |
9.6 (0.7, 33.1) |
NE (NE, NE) |
11.7 (8.0, NE) |
72.0 (50.1, 85.5) |
46.9 (26.6, 64.9) |
31.3 (13.4, 51.0) |
|
| Ovarian cancer |
IHC 3+ (n = 15) |
12.6 (4.1, NE) |
59.3 (30.7, 79.3) |
59.3 (30.7, 79.3) |
44.4 (18.9, 67.4) |
13.9 (4.4, NE) |
79.4 (48.8, 92.9) |
61.8 (30.4, 82.3) |
44.1 (16.7, 68.8) |
20.0 (7.2, NE) |
86.7 (56.4, 96.5) |
73.3 (43.6, 89.1) |
53.3 (26.3, 74.4) |
|
IHC 2+ (n = 25) |
4.4 (2.3, 7.1) |
42.1 (21.8, 61.2) |
14.0 (3.5, 31.6) |
4.7 (0.3, 19.4) |
5.6 (1.5, 8.2) |
48.9 (26.5, 68.0) |
18.3 (4.7, 39.0) |
12.2 (2.1, 31.9) |
10.7 (5.9, 14.8) |
71.6 (49.4, 85.3) |
46.3 (26.0, 64.4) |
21.1 (7.7, 38.8) |
|
| Bladder cancer |
IHC 3+ (n = 27) |
7.0 (3.9, 11.5) |
58.0 (37.0, 74.1) |
18.9 (6.2, 36.9) |
4.7 (0.3, 19.4) |
6.8 (2.6, 9.9) |
57.5 (36.4, 73.8) |
21.6 (7.4, 40.4) |
10.8 (1.9, 28.4) |
12.6 (6.7, 17.2) |
73.3 (52.0, 86.3) |
54.0 (33.4, 70.7) |
30.9 (14.7, 48.7) |
|
IHC 2+ (n = 14) |
7.0 (2.6, 13.0) |
57.1 (28.4, 78.0) |
28.6 (8.8, 52.4) |
14.3 (2.3, 36.6) |
7.0 (2.8, 11.1) |
57.9 (25.6, 80.2) |
19.3 (3.1, 46.0) |
19.3 (3.1, 46.0) |
13.5 (8.0, NE) |
85.7 (53.9, 96.2) |
78.6 (47.2, 92.5) |
35.7 (13.0, 59.4) |
|
| Other tumors |
IHC 3+ (n = 16) |
13.0 (6.3, NE) |
81.3 (52.5, 93.5) |
68.8 (40.5, 85.6) |
48.6 (22.9, 70.3) |
21.0 (5.6, 22.9) |
68.8 (40.5, 85.6) |
62.5 (34.9, 81.1) |
56.3 (29.5, 76.2) |
24.3 (11.1, NE) |
87.5 (58.6, 96.7) |
75.0 (46.3, 89.8) |
75.0 (46.3, 89.8) |
|
IHC 2+ (n = 24) |
6.6 (2.9, 8.8) |
51.2 (29.4, 69.4) |
18.6 (5.9, 37.0) |
18.6 (5.9, 37.0) |
8.4 (2.9, NE) |
75.1 (49.9, 88.9) |
35.0 (11.9, 59.6) |
23.4 (4.6, 50.3) |
15.5 (9.6, 22.4) |
95.8 (73.9, 99.4) |
68.5 (44.9, 83.6) |
41.1 (21.0, 60.2) |
|
| Biliary tract cancer |
IHC 3+ (n = 22) |
6.9 (3.0, 8.0) |
52.6 (29.9, 71.1) |
23.9 (8.7, 43.2) |
14.4 (3.6, 32.2) |
6.8 (2.8, 15.0) |
52.4 (29.7, 70.9) |
30.0 (11.4, 51.3) |
20.0 (4.4, 43.7) |
7.6 (4.6, NE) |
61.9 (38.1, 78.8) |
42.9 (21.9, 62.3) |
33.3 (14.9, 53.1) |
|
IHC 2+ (n = 19) |
3.7 (2.8, 5.1) |
15.8 (3.9, 34.9) |
5.3 (0.4, 21.4) |
5.3 (0.4, 21.4) |
3.0 (1.7, 4.2) |
10.5 (1.8, 28.4) |
5.3 (0.4, 21.4) |
5.3 (0.4, 21.4) |
5.3 (3.1, 10.2) |
42.1 (20.4, 62.5) |
15.8 (3.9, 34.9) |
15.8 (3.9, 34.9) |
|
| Pancreatic cancer |
IHC 3+ (n = 5) |
8.0 (1.2, NE) |
53.3 (6.8, 86.3) |
0.0 (NE, NE) |
0.0 (NE, NE) |
7.0 (1.4, NE) |
53.3 (6.8, 86.3) |
NE (NE, NE) |
NE (NE, NE) |
8.8 (2.4, NE) |
80.0 (20.4, 96.9) |
40.0 (5.2, 75.3) |
0.0 (NE, NE) |
|
IHC 2+ (n = 20) |
3.2 (1.4, 4.9) |
28.4 (10.4, 49.6) |
11.3 (1.9, 30.2) |
11.3 (1.9, 30.2) |
3.2 (1.2, 7.2) |
30.1 (11.4, 51.5) |
24.1 (7.7, 45.3) |
24.1 (7.7, 45.3) |
4.7 (3.2, 14.2) |
40.0 (19.3, 60.0) |
35.0 (15.7, 55.2) |
18.8 (5.2, 38.6) |
|
CI confidence interval, HER2 human epidermal growth factor receptor 2, ICR independent central review, IHC immunohistochemistry, NE not estimable, OS overall survival, PFS progression-free survival