Table 2.
Efficacy outcomes in the overall population and according to line of therapy
| Outcomea | Overall (n = 24) | By line of therapy |
||
|---|---|---|---|---|
| First line (n = 7) | Second line (n = 11) | Third line (n = 6) | ||
| Best overall response rate, n (%) | – | – | – | – |
| CR | 1 (4.2) | 1 (14.3) | 0 (0) | 0 (0) |
| PR |
9 (37.5) | 4 (57.1) | 3 (27.3) | 2 (33.3) |
| SD |
1 (4.2) | 0 (0) | 1 (9.1) | 0 (0) |
| PD |
5 (20.8) | 1 (14.3) | 3 (27.3) | 1 (16.7) |
| NE |
8 (33.3) | 1 (14.3) | 4 (36.4) | 3 (50.0) |
| ORR, n (%) [95% CI] | 10 (41.7) [22.1–63.4] | 5 (71.4) [29.0–96.3] | 3 (27.3) [6.0–61.0] | 2 (33.3) [4.3–77.7] |
| CBR, n (%) [95% CI] | 11 (45.8) [25.6–67.2] | 5 (71.4) [29.0–96.3] | 4 (36.4) [10.9–69.2] | 2 (33.3) [4.3–77.7] |
| DOR, median (95% CI), months | 14.3 (2.8–ne) | 14.3 (2.8–ne) | ne (ne–ne) | ne (3.2–ne) |
| OS, median (95% CI), months | 7.5 (4.0–15.6) | 14.3 (4.0–ne) | 7.5 (1.9–24.0) | 2.6 (0.6–ne) |
CBR, clinical benefit rate; CI, confidence interval; CR, complete response; DOR, duration of response; IRC, independent review committee; ne, not estimable; NE, not evaluable; ORR, objective response rate; OS, overall survival; PD, progressive disease; PR, partial response; SD, stable disease.
a
Best overall response, ORR, CBR, and DOR are per IRC assessment.