| Trial ID # | NCT03106987; OReO/ENGOT Ov-38 |
| Phase | III |
| Drug Class | DNA Damage Repair Pathway Inhibitors: PARP |
| Drug Name | Olaparib |
| Alternate Drug Names | Lynparza, AZD2281 |
| Drugs in Trial | Olaparib |
| Eligible Participant | Platinum sensitive ovarian cancer with CR or PR in most recent Pt-based therapy, with prior PARP inhibitor maintenance |
| Patients Enrolled | 220; median 4 prior therapies |
| Therapy Setting | Maintenance |
| Study Design | Double Blind, Randomized |
| Endpoints | PFS, evaluated per RECIST |
| Biomarkers | BRCA MUT |
| Efficacy | BRCA MUT: Ola (n=74) vs Placebo (n=38): non-BRCA MUT: Ola (n=72) vs Placebo (n=36): HRD-: Ola vs Placebo: HRD+: Ola vs Placebo: |
| Clinically Significant Adverse Events | Ola vs Placebo: |
| Conclusion | Rechallenge with maintenance olaparib following response to Pt-based therapy provides a significant improvement in PFS vs placebo, irrespective of BRCA status |
| Reference | Pujade-Lauraine E et al. Maintenance olaparib rechallenge in patients (pts) with ovarian carcinoma (OC) previously treated with a PARP inhibitor (PARPi): Phase IIIb OReO/ENGOT Ov-38 trial. Annals Oncol (2021) 32 (suppl_5): abstract LBA33 Olaparib Rechallenge Improves PFS in Relapsed Ovarian Cancer Previously Treated With PARP Inhibition, Onc Live, 9/17/21 |