Table 1.
Demographic and disease characteristics.
| Phase Ib | Samotolisib + enzalutamide | Placebo + enzalutamide | Total, phase II | |
|---|---|---|---|---|
| Parameters | n = 13 | n = 65 | n = 64 | N = 129 |
| Age in years, median (range) | 77 (61–88) | 69 (49–86) | 71 (45–91) | 70 (45–91) |
| Race, white | 11 (84.6) | 53 (81.5) | 55 (85.9) | 108 (83.7) |
| Time since initial diagnosis, median (range), months | 57.5 (13–256) | 67.1 (4–287) | 59.0 (4–287) | |
| ECOG PS, 0 / 1, n | 7/6 | 34/30 | 39/25 | 69/58 |
| Prior docetaxel for mHSPC | 17 (26.2) | 17 (26.6) | 34 (26.4) | |
| Visceral disease | 12 (18.5) | 14 (21.9) | 26 (20.2) | |
| Disease sites | ||||
| Bone | 59 (90.8) | 61 (95.3) | 120 (93.0) | |
| Distant lymph nodes | 19 (29.2) | 14 (21.9) | 33 (25.6) | |
| Local/regional lymph nodes | 18 (27.7) | 17 (26.6) | 35 (27.1) | |
| Liver | 5 (7.7) | 4 (6.3) | 9 (7.0) | |
| Lung | 7 (10.8) | 8 (12.5) | 15 (11.6) | |
Note: All values are represented in n (%), unless otherwise stated.
Abbreviations: mHSPC, metastatic hormone-sensitive prostate cancer; N, number of patients; n, number of patients per category.