Table 2: ORR per RECIST v1.1 by BICR.
|
LA Cohort n = 54 |
R/M Cohort n = 105 |
Total Population N = 159 |
|
|
ORR, % (95% CI) |
51.9 (37.8-65.7) |
35.2 (26.2-45.2) |
40.9 (33.2-48.9) |
|
DCR, % (95% CI) |
64.8 (50.6-77.3) |
52.4 (42.4-62.2) |
56.6 (48.5-64.4) |
|
Best overall response, n (%) |
|||
|
CR |
12 (22.2) |
13 (12.4) |
25 (15.7) |
|
PR |
16 (29.6) |
24 (22.9) |
40 (25.2) |
|
SD |
12 (22.2) |
30 (28.6) |
42 (26.4) |
|
SD ≥ 12 weeks |
7 (13.0) |
18 (17.1) |
25 (15.7) |
|
PD |
9 (16.7) |
28 (26.7) |
37 (23.3) |
|
NE/NAa |
5 (9.3) |
10 (9.5) |
15 (9.4) |
CR: Complete Response; NA: Not Available; NE; Not Evaluable; PD: Progressive Disease; PR: Partial Response; SD: Stable Disease
aPostbaseline assessment not evaluable or no postbaseline assessment available.