Table 4.
Antitumor activitya assessed by central review per RECIST v1.1 and duration of response
| Category | Cohort 2 N = 25 |
Cohort 3 N = 31 |
||
|---|---|---|---|---|
| n | % (95% CIb) | n | % (95% CIb) | |
| Objective response ratec | 15 | 60.0 (38.7–78.9) | 8 | 25.8 (11.9–44.6) |
| Disease control rated | 20 | 80.0 (59.3–93.2) | 11 | 35.5 (19.2–54.6) |
| Best overall response | ||||
| Complete response | 1 | 4.0 (0.1–20.4) | 2 | 6.5 (0.8–21.4) |
| Partial response | 14 | 56.0 (34.9–75.6) | 6 | 19.4 (7.5–37.5) |
| Stable disease | 8 | 32.0 (14.9–53.5) | 9 | 29.0 (14.2–48.0) |
| Progressive disease | 1 | 4.0 (0.1–20.4) | 12 | 38.7 (21.8–57.8) |
| Nonevaluable/no assessment | 1 | 4.0 (0.1–20.4) | 2 | 6.5 (0.8–21.4) |
| Median (range) time to response (months) | 2.1 (1.9–3.7) | 2.1 (1.5–6.2) | ||
| Median (range) duration of response (months) | 4.6 (2.6–20.3+) | 9.6 (2.1–17.8+) | ||
The + indicates that there was no progressive disease at last disease assessment
CI confidence interval, RECIST Response Evaluation Criteria in Solid Tumors
aConfirmed by repeat radiographic assessment ≥ 4 weeks after first documentation of response
bBased on binomial exact CI method
cComplete response + partial response
dComplete response + partial response + stable disease maintained for ≥ 6 months