Table 2.
Completed Phase II PARPi trials in prostate cancer.
| Study Name (NCT #) | Patient Population | Sample Size/Number of Pts | Study Design | PSA Response Rate | PFS (If Available) | Dosage | Reference |
|---|---|---|---|---|---|---|---|
| Monotherapy | |||||||
| TOPARP-B (NCT01682772) | mCRPC progression on abiraterone, enzalutamide, docetaxel, or cabazitaxel | 49 (16 with DDR mutations) | olaparib | 100% of BRCA2 and FANCA mutated mCRPC drop ≥50% baseline | median PFS, 9.8 vs. 2.7 months; p < 0.001 | 400 mg twice a day | Mateo J et al., [22] |
| TRITON2 (NCT02952534) | mCRPC and a DDR mutation previously been treated with abiraterone, enzalutamide, docetaxel, or cabazitaxel | 52 (23 BRCA-mutated) | rucaparib | 47.8% of BRCA-mutated; 95% CI, 26.8–69.4) | Not reported | 600 mg twice a day | Abida W et al., [23] |
| GALAHAD (NCT02854436) | mCRPC patients with DDR mutations and progression on a taxane or androgen-receptor signaling inhibitor | 39 | niraparib | 57% (95% CI, 34–77) | Not reported | 300 mg once a day | Smith MR et al., [24] |
| Combination Therapy | |||||||
| NCT01085422 | mCRPC | 26 | Veliparib and temozolomide | 8.0% (95% CI, 1.0–26.0) | 9 weeks (95% CI, 8–17) | 40 mg twice a day and 150–200 mg once a day | Hussain M et al., [25] |
| NCT01576172 | mCRPC | 148 (76 on abiraterone + veliparib | abiraterone versus abiraterone and veliparib | 72.4% | 10.1 versus 11 months (p = 0.95) | 1000 mg once a day and 40 mg twice a day | Hussain M et al., [26] |
| NCT01972217 | mCRPC previously treated with docetaxel or cabazitaxel | 142 (71 on the olaparib + abiraterone arm) | abiraterone versus abiraterone and olaparib | Not reported | 8.2 versus 13.8 months (p = 0.034) | 1000 mg once a day and 300 mg twice a day | Clarke N et al., [27] |
| cohort A of Keynote-365 (NCT02861573) | mCRPC previously treated with docetaxel or ≤2 androgen-receptor signaling inhibitors | 41 | Pembrolizumab and olaparib | 13% of patients had ≥50% PSA decline | 5 months (95% CI, 4–8) | 200 mg every 21 days and 400 mg twice a day | Yu EY et al., [28] |
| NCT03810105 | mCRPC previously treated with enzalutamide or abiraterone | 17 | durvalumab and olaparib | 53% of patients had a radiographic response and ≥50% PSA decline | 16.1 months (95% CI, 4.5–16.1) | 1500 mg every 28 days and 300 mg twice a day | Karzai F et al., [29] |