Table 4.
Major therapeutic benefits brought by enzalutamide based on PREVAIL.
| Enzalutamide PREVAIL Phase III Trial (NCT01212991) | |||
|---|---|---|---|
| End Points | Enzalutamide (n = 872) |
Placebo (n = 845) |
Hazard Ratio (95% CI) |
| Primary end point | |||
| Median OS (mo) | 18.4 | 13.6 | 0.63 |
| Median time to rPFS (mo) | 3.9 | 0.19 | |
| Secondary end points | |||
| Median time to first SRE (mo) | 16.7 | 13.3 | 0.69 |
| Median CC initiation time (mo) | 28 | 10.8 | 0.35 |
| Median time to PSA progression (mo) | 11.2 | 2.8 | 0.17 |
| * PSA response (%) of no. | |||
| decline ≥ 90% from baseline | 47 (854) | 1 (777) | |
| decline ≥ 50% from baseline | 78 (854) | 3 (777) | |
| * Serious AEs (%) of no. | 44.1 (871) | 3.5 (844) | |
OS: Overall Survival; rPFS: Radiographic Progression-free Survival; SRE: Skeletal-related Event; CC: Cytotoxic Chemotherapy; PSA: Prostate-specific Antigen; AEs: Adverse Events. * Does not include patients who discontinued or died during the trial.