Table 8.
Major therapeutic benefits brought by apalutamide based on TITAN.
| Apalutamide TITAN Phase III Trial (NCT02489318) | |||
|---|---|---|---|
| End Points | Apalutamide + ADT (n = 525) |
Placebo + ADT (n = 527) |
Hazard Ratio (95% CI) |
| Primary End Points | |||
| OS (% alive) | 82..4 | 73.5 | 0.67 |
| rPFS (%) | 68.2 | 47.5 | 0.48 |
| Secondary End Points | |||
| Median time to PSA progression (mo) | 12.9 | 0.26 | |
| * Serious AEs (%) of no. | 19.2 (574) | 20.3 (527) | |
OS: Overall Survival; rPFS: Radiographic Progression-free Survival; PSA: Prostate-specific Antigen; AEs: Adverse Events; * Does not include patients who discontinued or died during the trial.