| Trial ID # | NCT02476968; ORZORA |
| Phase | IV |
| Drug Class | DNA Damage Repair Pathway Inhibitors: PARP |
| Drug Name | Olaparib |
| Alternate Drug Names | AZD2281, Lynparza |
| Drugs in Trial | Olaparib |
| Eligible Participant | Platinum sensitive ovarian cancer with mutations in ATM, BARD1, BRCA1/2, BRIP1,CDK12, CHEK1/2, FANCL, PALB2, PPP2R2A, or RAD51B/C/D/L and with CR or PR to last platinum regimen |
| Patients Enrolled | 181 |
| Therapy Setting | Maintenance |
| Study Design | Open-Label, Non-randomized |
| Endpoints | PFS, evaluated per RECIST |
| Biomarkers | gBRCA status, sBRCA status, HRRm (13 gene panel) |
| Efficacy | gBRCA MUT (n=87) vs sBRCA MUT (n=55) vs HRRm (n=33): PFS: 18.0 vs 16.6 vs 16.4 months |
| Clinically Significant Adverse Events | gBRCA MUT vs sBRCA MUT vs HRRm: |
| Conclusion | PFS in patients with platinum sensitive ovarian cancer who received maintenance olaparib is similar irrespective of somatic or germline BRCA status and activity of maintenance olaparib is also seen in patients with a non-BRCA HRR gene mutation |
| Reference | Pignata S et al. ORZORA: Maintenance olaparib in patients with platinum-sensitive relapsed ovarian cancer: Outcomes by somatic and germline BRCA and other homologous recombination repair gene mutation status. SGO (2021) abstract 10503 |