Table 6.
Major therapeutic benefits brought by enzalutamide based on ARCHES.
| Enzalutamide ARCHES Phase III Trial (NCT02677896) | |||
|---|---|---|---|
| End Points | Enzalutamide + ADT (n = 574) |
Placebo + ADT (n = 576) |
Hazard Ratio (95% CI) |
| Primary End Point | |||
| ‡ Median time to rPFS based on ICR via PCWG2 (mo) | 19.4 | 0.39 | |
| † Median time to rPFS based on ICR via PAC (mo) | 19.0 | 0.39 | |
| Secondary End Points | |||
| Median OS (mo) | 0.19 | ||
| Time to NAT | 30.2 | 0.28 | |
| Median time to CR (mo) | 13.9 | 0.28 | |
| PSA undetctable rate (%) of no. | 68.1 (511) | 17.6 (506) | |
| * Serious AEs (%) of no. | 18.2 (572) | 19.5 (574) | |
rPFS: Radiographic Progression-free Survival; OS: Overall Survival; NAT: New Antineoplastic Therapy; CR: Castration resistance; PSA: Prostate-specific Antigen; AEs: Adverse Events; ‡ Radiographic Progression-Free Survival (rPFS) Based on Independent Central Review (ICR) of Bone Scan According to Prostate Cancer Clinical Trials Working Group 2 (PCWG2) Criteria; † rPFS Based on ICR of Bone Scan According to Protocol Assessment Criteria; * Does not include patients who discontinued or died during the trial.