A Phase III Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib in Newly Diagnosed Advanced Ovarian Cancer Patients (DUO-O).

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


Therapy Setting


Study Design

Double Blind, Randomized


PFS, evaluated per RECIST


tBRCA status, Exploratory: HRD status


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:

PFS: 24.2 vs 20.6 vs 19.3 months; HR: 0.63 (0.52-0.76), p<0.0001; HR: 0.87 (0.73-1.04), p=0.13
HRD+ (excl. tBRCA MUT):
PFS: 37.3 vs 24.4 vs 23.0 months; HR: 0.49 (0.34-0.69), p<0.0001; HR: 0.82 (0.60-1.12)

Exploratory analysis; HRD-:
PFS: 20.9 vs 15.4 vs 17.4 months; HR: 0.68 (0.54-0.86); HR: 0.94 (0.75-1.18)

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:
Serious AE: overall (39 vs 43 vs 34%); MDS/AML: (2 vs 0 vs 1)
Grade 3-4 AE: overall (71 vs 66 vs 61%); neutropenia (31 vs 28 vs 26%); anemia (24 vs 8 vs 8%)


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


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

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