Outcome | Primary analysis (9 months after completion of accrual) | Long-term analysis (39 months after completion of accrual) | ||
---|---|---|---|---|
mBCC | laBCC | mBCC | laBCC | |
(n = 33) | (n = 63) | (n = 33) | (n = 63) | |
Objective response, n (%) [95% CI] | 15 (45.5) [28.1–62.2] | 38 (60.3) [47.2–71.7] | 16 (48.5) [30.8–66.2] | 38 (60.3) [47.2–71.7] |
Complete response | 0 | 20 | 0 | 20 |
Partial response | 15 | 18 | 16 | 18 |
Stable disease | 15 | 15 | 14 | 15 |
Progressive disease | 2 | 6 | 2 | 6 |
Median DOR, mo [95% CI] Number of responders | 12.9 [5.6–12.9] 15 | 7.6 [7.4–NE] 38 | 14.8 [5.6–17.0] 16 | 26.2 [9.0–37.6] 38 |
Median PFS, mo [95% CI] Number of events, n | 9.2 [7.4–NE] 17 | 11.3 [9.5–16.8] 26 | 9.3 [7.4–16.6] 24 | 12.9 [10.2–28.0] 34 |
Median OS, mo [95% CI] Number of events, n | NE [13.9–NE] 7 | NE [17.6–NE] 6 | 33.4 [18.1–NE] 17 | NE [NE] 13 |
1-year survival rate, % [95% CI] | 75.5 [57.3–93.6] | 91.6 [83.5–99.7] | 78.7 [64.7–92.7] | 93.2 [86.8–99.6] |
2-year survival rate, % [95% CI] | NE | NE | 62.3% [45.4–79.3] | 85.5% [76.1–94.8] |