Table 2.
Confirmed objective responses
| Response | 1 L (n = 62) | 2 L (n = 20) |
|---|---|---|
| Best overall response, n (%) | ||
| Complete response | 1 (1.6) | 0 |
| Partial response | 9 (14.5) | 2 (10.0) |
| Stable disease | 38 (61.3) | 13 (65.0) |
| Progressive disease | 11 (17.7) | 4 (20.0) |
| Not evaluable | 3 (4.8)a | 1 (5.0)b |
| Objective response rate (95% CI), % | 16.1 (8.0–27.7) | 10.0 (1.2–31.7) |
| Disease control rate, % | 77.4 | 75.0 |
| Response duration | 1 L (n = 10) | 2 L (n = 2) |
| Median duration of response (95% CI), months | 9.9 (2.8–NE) | NE (6.9–NE) |
| Proportion of patients with specified duration of response (95% CI), %c | ||
| 6 months | 60.0 (25.3–82.7) | 100.0 (NE) |
| 12 months | 30.0 (7.1–57.8) | 50.0 (0.6–91.0) |
a Due to no postbaseline assessment (n = 2) or stable disease of insufficient duration (< 6 weeks after start date without further tumor assessment; n = 1)
b All postbaseline assessments not evaluable (n = 1)
c Based on Kaplan-Meier estimates
1 L first-line subgroup, 2 L second-line subgroup, CI confidence interval, NE not evaluable