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: 12 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 (pts) with ovarian carcinoma (OC) previously treated with a PARP inhibitor (PARPi): Phase IIIb OReO/ENGOT Ov-38 trial. Annals Oncol (2021) 32 (suppl_5): abstract LBA33
https://oncologypro.esmo.org/meeting-resources/esmo-congress-2021/maintenance-olaparib-rechallenge-in-patients-pts-with-ovarian-carcinoma-oc-previously-treated-with-a-parp-inhibitor-parpi-phase-iiib-oreo-en

Olaparib Rechallenge Improves PFS in Relapsed Ovarian Cancer Previously Treated With PARP Inhibition, Onc Live, 9/17/21
https://www.onclive.com/view/olaparib-rechallenge-improves-pfs-in-relapsed-ovarian-cancer-previously-treated-with-parp-inhibition

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