Table 3.
Efficacy outcomes
| By investigator (N=30) |
By IRC (N=30) |
|
| Best overall response | ||
| Complete response | 1 (3) | 2 (7) |
| Partial response | 6 (20) | 4 (13) |
| Stable disease | 4 (13) | 6 (20) |
| Progressive disease | 17 (57) | 16 (53) |
| Not evaluable | 2 (7) | 2 (7) |
| Objective response rate | 7 (23%, 95% CI 10 to 42) | 6 (20%, 95% CI 8 to 39) |
| Objective response by biliary tract cancer subtype | ||
| Ampullary cancer | 0/1 (0) | 0/1 (0) |
| Extrahepatic cholangiocarcinoma | 1/7 (14) | 0/7 (0) |
| Gallbladder cancer | 2/12 (17)* | 3/12 (25) |
| Intrahepatic cholangiocarcinoma | 4/10 (40%) | 3/10 (30%) |
| Disease control rate | 11 (37%, 95% CI 20 to 56) | 12 (40%, 95% CI 23 to 59) |
| Median duration of response (range), months | 9.7 (2.8–12.5) | NE (8.3–14.5) |
| Median progression-free survival (95% CI), months | 2.5 (1.3 to 4.0) | 2.5 (1.3 to 5.6) |
| Median overall survival (95% CI), months | 12.7 (6.7 to 15.7) | |
Data are n (%) unless otherwise specified.
Responses were assessed in accordance with Response Evaluation Criteria in Solid Tumors version 1.1.
Only confirmed responses are included.
*One patient with gallbladder cancer had a partial response per IRC and initial pseudoprogression on the first evaluation visit, followed by a partial response as assessed by the investigator (investigator-assessed best overall response, progressive disease).
NE, not evaluable.