Table 2.
ARMOR169 | ARMOR2, part 169 | ARMOR2, parts 1 and 2 (combined study)70 | |
---|---|---|---|
Number of patients | 49 | 28 | 107 |
Metastatic disease (M) | 51% | 86% | 77% |
Abi-R or Enz-R patients | No | Abi-R: three patients | Abi-R: 37 patients Enz-R: nine patients |
Drug formulation | Capsules | SDD tablets | SDD tablets |
Food effect | Yes | No | No |
Dose range | 650 mg | 1,700 mg | 2,550 mg |
975 mg | 2,550 mg | ||
1,300 mg | 3,400 mg | ||
1,950 mg | |||
2,600 mg | |||
PSA decline ≥30% | 49% | 64% | 83%a |
PSA50 | 22.4% | 48% | 70%a |
Note:
PSA decline results in the M0 and M1 treatment-naïve cohorts.
Abbreviations: Abi-R, abiraterone refractory; Enz-R, enzalutamide refractory; SDD, spray dry dispersion; PSA50, PSA decline ≥50%.