Table 1.
Olaparib for the treatment of prostate cancer (PC)
| Trials | Study design | Eligibility | Study arms | Primary endpoint | Results |
|---|---|---|---|---|---|
| TOPARP9 | Phase II | Advanced castration-resistant PC | Oral olaparib* | RR | RR: 33% |
| PFS**: 9.8 mo vs 2.7 mo*** | |||||
| OS**: 13.8 mo vs 7.5 mo*** | |||||
| Kaufman et al24 | Phase II | BRCA1/2-mutated advanced solid tumor (PC cohort, n=8) | Oral olaparib* | RR | RR in PC: 50% |
| PFS in PC: 7.2 mo | |||||
| OS in PC: 18.4 mo | |||||
| NCT0197221725 | Randomized phase II | Metastatic castration-resistant PC | Olaparib + abiraterone | Safety | PFS, RR, OS (ongoing) |
| Placebo + abiraterone | |||||
| NCT0248440426 | Phase I/II | Advanced or recurrent solid tumor | PDL-1 + olaparib | Safety | Recommended dose (ongoing) |
| PDL-1 + cediranib | |||||
| PDL-1 + olaparib + cediranib | |||||
| Keynote-36527 | Phase I/II | Metastatic castration-resistant PC | Pembrolizumab + olaparib | Safety | Adverse events, RR, OS (ongoing) |
| Pembrolizumab + docetaxel | |||||
| Pembrolizumab + enzalutamide | |||||
| NCT0289391728 | Randomized phase II | Metastatic castration-resistant PC | Olaparib + cediranib | PFS | PFS, RR, OS (ongoing) |
| Olaparib + placebo | |||||
| NCT0232499829 | Phase I | Intermediate-/high-risk PC | Olaparib | Degree PARP inhibition | Adverse events (ongoing) |
Notes:
*
400 mg twice daily, continuously on a 28-day cycle;
**
biomarker positive versus biomarker negative;
***
P≤0.05.
Abbreviations: RR, response rate; PFS, progression-free survival; OS, overall survival; mo, months; PDL-1, programmed death ligand-1; PARP, poly(ADP-ribose) polymerase.