Table 2.
Objective and PSA response outcomes in cohort A1 and A2
| Cohort A1 (postchemotherapy) (N=88) |
Cohort A2 (chemotherapy-naïve) (N=71) |
|||||
| Overall | HRD-positive | HRD-negative/not evaluable | Overall | HRD-positive | HRD-negative/not evaluable | |
| Objective response* | ||||||
| Evaluable patients, n† | 58 | 29 | 29 | 39 | 20 | 19 |
| Confirmed ORR (95% CI), % | 10.3 (3.9 to 21.2) | 17.2 (5.8 to 35.8) | 3.4 (0.1 to 17.8) | 15.4 (5.9 to 30.5) | 25.0 (8.7 to 49.1) | 5.3 (0.1 to 26.0) |
| BOR, n (%) | ||||||
| Complete response Partial response Stable disease Progressive disease Unable to determine |
0 6 (10.3) 31 (53.4) 18 (31.0) 3 (5.2) |
0 5 (17.2) 16 (55.2) 5 (17.2) 3 (10.3) |
0 1 (3.4) 15 (51.7) 13 (44.8) 0 |
0 6 (15.4) 26 (66.7) 5 (12.8) 2 (5.1) |
0 5 (25.0) 11 (55.0) 3 (15.0) 1 (5.0) |
0 1 (5.3) 15 (78.9) 2 (10.5) 1 (5.3) |
| PSA response‡ | ||||||
| Evaluable patients, n§ | 84 | 44 | 40 | 66 | 31 | 35 |
| Confirmed PSA50-RR (95% CI), % | 11.9 (5.9 to 20.8) | 18.2 (8.2 to 32.7) | 5.0 (0.6 to 16.9) | 27.3 (17.0 to 39.6) | 41.9 (24.5 to 60.9) | 14.3 (4.8 to 30.3) |
| Confirmed or unconfirmed PSA50-RR (95% CI), % |
19.0 (11.3 to 29.1) | 29.5 (16.8 to 45.2) | 7.5 (1.6 to 20.4) | 31.8 (20.9 to 44.4) | 48.4 (30.2 to 66.9) | 17.1 (6.6 to 33.6) |
*Confirmed complete or partial response per PCWG3.
†Patients with measurable disease at baseline.
‡A decrease in PSA from baseline to the lowest postbaseline PSA result of ≥50%; a second consecutive value obtained at least 3 weeks later was required for confirmation of PSA responses.
§Patients with a baseline and at least one postbaseline PSA assessment.
BOR, best overall response; HRD, homologous recombination deficiency; ORR, objective response rate; PCWG3, Prostate Cancer Clinical Trials Working Group 3; PSA, prostate-specific antigen; PSA50-RR, PSA response rate.