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	Maintenance
Study Design	Double Blind, Randomized
Endpoints	PFS, evaluated per RECIST
Biomarkers	BRCA MUT
Efficacy	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%)
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 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 https://pubmed.ncbi.nlm.nih.gov/37797734/