A Phase IIIb, Randomised, Double-blind, Placebo-controlled, Multicentre Study of Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer Previously Treated With a PARPi and Responding to Repeat Platinum Chemotherapy

Trial ID # NCT03106987; OReO/ENGOT Ov-38
Phase III
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 CR or PR in most recent Pt-based therapy, with prior PARP inhibitor maintenance

Patients Enrolled

220; median 4 prior therapies

Therapy Setting


Study Design

Double Blind, Randomized


PFS, evaluated per RECIST




BRCA MUT: Ola (n=74) vs Placebo (n=38):
PFS: 4.3 vs 2.8 months; HR: 0.57 (0.37-0.87, p=0.022)
PFS at 12 months: 19 vs 0%

non-BRCA MUT: Ola (n=72) vs Placebo (n=36):
PFS: 5.3 vs 2.8 months; HR: 0.43 (0.26-0.71, p=0.0023)
PFS at 12 months: 14 vs 0%

HRD-: Ola vs Placebo:
PFS: 5.4 vs 2.8 months

HRD+Ola vs Placebo:
PFS: 5.3 vs 2.8 months

Clinically Significant Adverse Events

Ola vs Placebo:
Serious AE:
Grade 3-4 AE: BRCA MUT overall: (15 vs 5%); non-BRCA MUT overall (21 vs 8%)


Rechallenge with maintenance olaparib following response to Pt-based therapy provides a significant improvement in PFS vs placebo, irrespective of BRCA status


Pujade-Lauraine E et al. Maintenance olaparib rechallenge in patients with platinum-sensitive relapsed ovarian cancer previously treated with a PARP inhibitor (OReO/ENGOT-ov38): a phase IIIb trial. Ann Oncol (2023) 34(12):1152-1164

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