Tumor response according to independent review per RECIST 1.1
| Response | Patients (N=116) |
| Best overall response, n (%) | |
| Complete response | 19 (16.4) |
| Partial response | 27 (23.3) |
| Stable disease | 12 (10.3) |
| Noncomplete response/nonprogressive disease | 1 (0.9) |
| Progressive disease | 48 (41.4) |
| Not evaluable | 9 (7.8)* |
| Objective response rate (95% CI), % | 39.7 (30.7–49.2) |
| Patients with response, n | 46 |
| Median duration of response (95% CI), months† | 18.2 (11.3-not estimable) |
| Range | 1.2–28.3 |
| Proportion with duration of response (95% CI), %† | |
| ≥6 months | 78 (63–87) |
| ≥12 months | 66 (50–78) |
| ≥18 months | 52 (34–67) |
| ≥24 months | 45 (25–63) |
| Patients with durable response, n | 35 |
| Durable response rate (95% CI), %‡ | 30.2 (22.0–39.4) |
*No post-baseline assessments due to early death (n=4) or other reasons (n=2), no adequate baseline assessment (n=2), or all post-baseline assessments had overall response of not evaluable (n=1).
†Based on Kaplan-Meier estimates.
‡Proportion of patients with a response lasting ≥6 months.
RECIST 1.1, Response Evaluation Criteria in Solid Tumors version 1.1.