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: 14.5 months - unstable, less than 50% maturity

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 for non-germline BRCA1/2-mutated (non-gBRCAm) platinum-sensitive relapsed ovarian cancer (PSR OC) patients (pts): Phase IIIb OPINION interim analysis.
https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.6057

Poveda A et al. Poster
https://www.clearityfoundation.org/wp-content/uploads/2020/07/Olaparib-OPINION-ASCO-2020.pdf

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