Table 2.
Efficacy outcomes
| AAP-naïve mCRPC (n = 25) | Post-AAP mCRPC (n = 18) | |
|---|---|---|
| PSA response ratea, n (%) | ||
| 12 weeks | 22 (88) | 4 (22) |
| 24 weeks | 20 (80) | 1 (6) |
| 36 weeks | 17 (68) | 0 |
| Maximal PSA responseb, n (%) | 23 (92) | 5 (28) |
| Median time to PSA progression, months (95% CI) | 18.2 (8.3–NR) | 3.7 (2.8–5.6) |
| Median PFSc, months (95% CI) | NR (16.7–NR) | NR (NR–NR) |
| ORRd, n/N (%) | 4/8 (50) | 0/10 (0) |
Abbreviations: ORR, objective response rate; PFS, progression-free survival.
a
≥50% decline in PSA from baseline from PCWG2 criteria.
b
Maximal PSA response is the maximal percent reduction post baseline for the individual patient at any time point.
c
Per protocol, patients who had progressive disease that was not confirmed prior to subsequent therapy were censored back to their last assessment prior to subsequent therapy.
d
Eight patients in the AA-naïve cohort and 10 patients in the post-AAP mCRPC cohort had measurable disease at baseline.