TABLE 2.
Secondary endpoint: efficacy
| Enzalutamide Cohort 1: chemotherapy naïve + abiraterone naïve (n = 1171) | Enzalutamide Cohort 2: postchemotherapy + abiraterone naïve (n = 418) | |
|---|---|---|
| PSA progression a | ||
| Time to PSA progression, months, median (95% CI) | 17.7 (16.3‐18.7) | 9.8 (8.5‐11.5) |
| Patients with PSA progression | 476 (40.6) | 241 (57.7) |
| PSA response rate b | ||
| 30% (95% CI) | 82.4 (80.1‐84.7) | 69.1 (64.5‐73.7) |
| 50% (95% CI) | 76.2 (73.6‐78.7) | 60.5 (55.6‐65.4) |
| 90% (95% CI) | 44.9 (41.9‐47.9) | 31.2 (26.5‐35.8) |
| Disease progression | ||
| Time to disease progression, months, median (95% CI) | 13.9 (12.8‐15.1) | 7.2 (6.2‐8.3) |
| Patients with disease progression c | 595 (50.8) | 302 (72.2) |
| PSA progression | 473 (40.4) | 241 (57.7) |
| Radiographic progression | 327 (27.9) | 190 (45.5) |
| Clinical progression | 163 (13.9) | 101 (24.2) |
Note: Data presented as n (%) unless otherwise stated. Data from FAS (n = 1727).
a
PSA progression was defined as a PSA rise of ≥25% and an absolute increase of ≥2 ng/mL above nadir.
b
Defined as best percentage change in PSA levels from baseline.
c
The percentage of patients with any type of disease progression calculated within the overall cohort; a patient can belong to more than one subcategory of disease progression.