Table 7.
Major therapeutic benefits brought by apalutamide based on SPARTAN.
| Apalutamide SPARTAN Phase III Trial (NCT01946204) | |||
|---|---|---|---|
| End Points | Apalutamide (n = 806) |
Placebo (n = 401) |
Hazard Ratio (95% CI) |
| Primary End Points | |||
| Median MFS (mo) | 40.5 | 16.2 | 0.28 |
| Secondary End Points | |||
| Median time to metastasis (mo) | 40.5 | 16.6 | 0.28 |
| Median time to PFS (mo) | 40.5 | 14.7 | 0.29 |
| Median OS (mo) | 39.0 | ||
| Median time to CC (mo) | |||
| * Serious AEs (%) of no. | 24.8 (803) | 23.1 (398) | |
MFS: Metastasis Free Survival; PFS: Progression Free Survival; OS: Overall Survival; CC: Cytotoxic Chemotherapy; AEs: Adverse Events; * Does not include patients who discontinued or died during the trial.