Variable | Level | Arm A (n=9) | Arm B (n=9) | Combined, n (%) (N=18) |
Age | Mean | 70.5 | 66.86 | 67.76 |
Gender | Female | 3 | 4 | 7 (38.9) |
Male | 6 | 5 | 11 (61.1) | |
Race | Asian | 0 | 1 | 1 (5.6) |
Black or African American | 0 | 3 | 3 (16.7) | |
Unknown | 1 | 0 | 1 (5.6) | |
White | 8 | 5 | 13 (72.2) | |
Ethnicity | Non-Hispanic | 18 (100.0) | ||
Platinum-sensitive | 5 | 4 | 9 (50.0) | |
4 | 5 | 9 (50.0) | ||
Prior lines of treatment | 1 | 6 | 7 | 13 (72.2) |
2 | 3 | 2 | 5 (27.8) | |
Best response | PR | 0 (0%) | 2 (28.6%) | 2 (11.1) |
SD | 2 (25%) | 1 (14.3%) | 3 (16.7) | |
PD | 6 (75%) | 4 (57.1%) | 10 (55.6) | |
NE | 1 | 2 | 3 (16.7) | |
OS | Median (months) | 2.8 (0.8, 12.4) | 5.7 (1.6, 14.5) | 3.90 |
6 months (%) | 37.5 (8.7, 67.4) | 42.9 (9.8, 73.4) | ||
12 months (%) | 25.0 (3.7, 55.8) | 28.6 (4.1, 61.2) | ||
PFS | Median (months) | 2.1 (0.8, 3.2) | 3.3 (0.9, 4.9) | 2.76 |
6 months (%) | 0.0 (0.0, 0.0) | 0.0 (0.0, 0.0) |
NE: not evaluable
OS, overall survival; PD, progressive disease; PFS, progression-free survival; PR, partial response; SD, stable disease.