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 Lynparza, AZD2281
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/

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