A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non-Germline BRCA Mutated Ovarian Cancer Patients Who Are in Complete or Partial Response Following Platinum Based Chemotherapy

Trial ID #	NCT03402841; OPINION
Phase	IIIb
Drug Class	DNA Damage Repair Pathway Inhibitors: PARP
Drug Name	Olaparib
Alternate Drug Names	AZD2281, Lynparza
Drugs in Trial	Olaparib
Eligible Participant	non-gBRCA MUT with Pt-sensitive recurrence and CR or PR in most recent Pt-based therapy, ≥ 2 Pt-based regimens
Patients Enrolled	279, median 2 prior therapies, 94.3% non-gBRCA MUT, 5.7% unknown
Therapy Setting	Maintenance
Study Design	Open-Label, Non-randomized
Endpoints	PFS, evaluated per RECIST
Biomarkers	non-gBRCA1/2 MUT, Exploratory: HRD status by Myriad myChoice
Efficacy	non-gBRCA MUT (n=279): PFS: 9.2 months HRD- (n=115): PFS: 7.3 months HRD+ (excl. sBRCA MUT, n=94): PFS: 9.7 months sBRCA MUT (n=34): PFS: 16.4 months
Clinically Significant Adverse Events	Serious AE: overall (18.6%), 1 MDS Grade 3-4 AE: overall (25.8%), anemia (12.9%)
Conclusion	Maintenance olaparib demonstrates activity in non-gBRCA MUT ovarian cancer patients with no new safety signals
Reference	Poveda A et al. Olaparib maintenance monotherapy in platinum-sensitive relapsed ovarian cancer patients without a germline BRCA1/BRCA2 mutation: OPINION primary analysis. Gynecol Oncol (2022) 164(3):498-504 https://pubmed.ncbi.nlm.nih.gov/35063276/