Trial ID # | NCT03737643; DUO-O |
Phase | III |
Drug Class | Immunotherapy: Checkpoint Inhibitors/PD-L1 |
Drug Name | Durvalumab |
Alternate Drug Names | Anti-B7H1 Monoclonal Antibody MEDI4736, MEDI4736, Imfinzi |
Drugs in Trial | Bevacizumab, Carboplatin, Durvalumab, Olaparib, Paclitaxel |
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, OS, evaluated per RECIST |
Biomarkers | tBRCA status, Exploratory: HRD status |
Efficacy | CarboPt+Pac+Bev+Dur w/Bev+Dur+Ola maint vs CarboPt+Pac+Bev+Dur w/ Bev+Dur+Ola Placebo maint (n= 374) vs CarboPt+Pac+Bev+Dur Placebo w/ Bev+Dur placebo (n=378) +Ola Placebo maint: ITT (excl. BRCA MUT): Exploratory analysis; HRD-: |
Clinically Significant Adverse Events | CarboPt+Pac+Bev+Dur w/Bev+Dur+Ola maint vs CarboPt+Pac+Bev+Dur w/ Bev+Dur+Ola Placebo maint (n= 374) vs CarboPt+Pac+Bev+Dur Placebo w/ Bev+Dur placebo (n=378) +Ola Placebo 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 Harter P et al. Durvalumab plus paclitaxel/carboplatin plus bevacizumab followed by durvalumab, bevacizumab plus olaparib maintenance among patients with newly-diagnosed advanced ovarian cancer without a tumor BRCA1/BRCA2 mutation: Updated results from DUO-O/ENGOT-OV46/GOG-3025 Trial. SGO (2024) |