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Olaparib maintenance monotherapy in platinum-sensitive relapsed ovarian cancer patients without a germline

A Poveda1, S Lheureux2, N Colombo3

  • 1Initia Oncology, Valencia, Spain.

Gynecologic Oncology
|January 22, 2022
PubMed
Abstract

Insights

Olaparib maintenance monotherapy showed clinical benefit in patients with platinum-sensitive relapsed ovarian cancer without germline BRCA mutations. The drug demonstrated efficacy across biomarker subgroups with manageable side effects.

Area of Science:

  • Oncology
  • Clinical Trials
  • Pharmacology

Background:

  • Platinum-sensitive relapsed ovarian cancer (PSROC) presents a treatment challenge, particularly in patients without germline BRCA mutations (gBRCAm).
  • Maintenance therapy aims to prolong remission after response to platinum-based chemotherapy.
  • Olaparib, a PARP inhibitor, has shown efficacy in BRCA-mutated ovarian cancer, prompting investigation in broader populations.

Purpose of the Study:

  • To evaluate the efficacy and safety of olaparib maintenance monotherapy in patients with PSROC who lack a deleterious or suspected deleterious gBRCAm.
  • To assess progression-free survival (PFS) as the primary endpoint.
  • To explore PFS in relation to homologous recombination deficiency (HRD) and somatic BRCAm (sBRCAm) status.

Main Methods:

  • Phase IIIb, single-arm, open-label, international OPINION trial (NCT03402841).
  • 279 patients with PSROC and no gBRCAm received olaparib maintenance (300 mg twice daily) post-platinum chemotherapy response.
  • Primary endpoint: investigator-assessed PFS. Secondary endpoints included PFS by HRD and sBRCAm status.

Main Results:

  • Median PFS was 9.2 months in the overall population (n=279).
  • PFS varied by biomarker status: 16.4 months (sBRCAm), 11.1 months (HRD-positive including sBRCAm), 9.7 months (HRD-positive excluding sBRCAm), and 7.3 months (HRD-negative).
  • Most common adverse events included nausea (48.4%) and fatigue (44.1%); 7.5% discontinued treatment due to toxicity.

Conclusions:

  • Maintenance olaparib demonstrated clinical benefit in patients with PSROC without gBRCAm, including various biomarker subgroups.
  • The safety profile was consistent with previous olaparib studies, with no new safety signals identified.
  • Olaparib represents a potential maintenance strategy for a broader population of ovarian cancer patients beyond those with gBRCAm.
Keywords:
BRCAMaintenanceOlaparibOvarian cancer

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