Table 1.
Summary of patient demographics and baseline characteristics.
| Category | ADXS31-142 monotherapy (n = 13) |
ADXS31-142 + pembrolizumab (n = 37) |
|---|---|---|
| Age, median (range), years | 69.0 (57-80) | 68.0 (45-92) |
| Weight, mean ± SD (range), kg | 87.7 ± 16.98 (56-117) | 93.7 ± 21.91 (55-157) |
| BMI, mean ± SD (range), kg/m2 | 28.5 ± 5.24 (19-37) | 29.8 ± 6.03 (21-50) |
| ECOG PS 0/1, % | 53.8/46.2 | 48.6/51.4 |
| PSA level, median (range), ng/mL | 19.0 (4.2-2456.0) | 41.5 (0.1-426.3) |
| Time from initial diagnosis to first dose of ADXS31-142, mean ± SD (range), months | 90.2 ± 70.30 (17-247) | 72.3 ± 55.57 (11-215) |
| Prior therapy, n (%) | ||
| Chemotherapy | 4 (30.8) | 21 (56.8) |
| Docetaxel | 4 (30.8) | 20 (54.1) |
| Immunotherapy | 6 (46.2) | 7 (18.9) |
| Hormonal | 11 (84.6) | 34 (91.9) |
| Next-generation hormonal agents, n (%) | ||
| Abiraterone only | 3 (23.1) | 6 (16.2) |
| Enzalutamide only | 2 (15.4) | 12 (32.4) |
| Abiraterone and enzalutamide | 1 (7.7) | 12 (32.4) |
| Presence of visceral metastases, n (%) | ||
| Yes | 2 (15.4) | 11 (29.7) |
| No | 11 (84.6) | 26 (70.3) |
Abbreviations: BMI, body mass index; ECOG, Eastern Cooperative Oncology Group; PS, performance status; PSA, prostate-specific antigen; SD, standard deviation.