| Trial ID # | NCT03737643; DUO-O |
| Phase | III |
| Drug Class | DNA Damage Repair Pathway Inhibitors: PARP |
| Drug Name | Olaparib |
| Alternate Drug Names | AZD2281, Lynparza |
| Drugs in Trial | Bevacizumab, Carboplatin, Durvalumab, Paclitaxel, Olaparib |
| Eligible Participant | Newly diagnosed stage III/IV high grade non-gBRCA MUT ovarian cancer (neo-adjuvant or adjuvant and maintenance) |
| Patients Enrolled | 1130 |
| Therapy Setting | First-line |
| Study Design | Double Blind, Randomized |
| Endpoints | PFS, evaluated per RECIST |
| Biomarkers | tBRCA status, Exploratory: HRD status |
| Efficacy | CarboPt+Pac+Bev+Dur Placebo w/ Bev+Dur placebo+Ola Placebo maint vs CarboPt+Pac+Bev+Dur w/ Bev+Dur+Ola Placebo maint vs CarboPt+Pac+Bev+Dur w/Bev+Dur+Ola maint: ITT: Exploratory analysis; HRD-: |
| Clinically Significant Adverse Events | CarboPt+Pac+Bev+Dur Placebo w/ Bev+Dur placebo+Ola Placebo maint vs CarboPt+Pac+Bev+Dur w/ Bev+Dur+Ola Placebo maint vs CarboPt+Pac+Bev+Dur w/Bev+Dur+Ola maint: |
| Conclusion | CarboPt+Pac+Bev+Dur followed by maintenance Bev+Dur+Ola in patients with newly diagnosed non-tBRCAm advanced OC resulted in a statistically significant and clinically meaningful improvement in PFS vs CarboPt+Pac+Bev followed by maintenance Bev. Safety was generally consistent with the known profiles of each agent |
| Reference | Harter P et al. Durvalumab with paclitaxel/carboplatin (PC) and bevacizumab (bev), followed by maintenance durvalumab, bev, and olaparib in patients (pts) with newly diagnosed advanced ovarian cancer (AOC) without a tumor BRCA1/2 mutation (non-tBRCAm): Results from the randomized, placebo (pbo)-controlled phase III DUO-O trial. J Clin Oncol 41, 2023 (suppl 17; abstr LBA5506) Harter P et al. Slide from presentation |