Phase 3b OPINION Primary Analysis of Olaparib Maintenance Monotherapy for Nongermline BRCA1/2-Mutated Platinum-Sensitive Relapsed Ovarian Cancer

2021 Year in Review - Ovarian Cancer - Ovarian Cancer

Results of the primary analysis of the phase 3b OPINION study supported the use of olaparib maintenance therapy in patients with nongermline BRCA1/2-mutated platinum-sensitive relapsed ovarian cancer.

The phase 3b, single-arm, OPINION study (NCT03402841) investigated olaparib maintenance monotherapy in patients with nongermline BRCA1/2-mutated (non-gBRCAm) platinum-sensitive relapsed ovarian cancer. The results of this study were presented at the 2021 American Society of Clinical Oncology Annual Meeting.

Key eligibility criteria were relapsed high-grade serous or endometrioid ovarian cancer harboring non-gBRCAm, ≥2 previous lines of platinum-based chemotherapy, and complete response or partial response to last platinum-based chemotherapy. Eligible patients received maintenance olaparib (300 mg orally, twice a day) until disease progression or unacceptable toxicity. The primary end point was investigator-assessed progression-free survival (PFS). Secondary end points included PFS by homologous recombination deficiency (HRD) and somatic BRCA mutation (sBRCAm) status, as assessed by central Myriad tumor and germline testing; time to first subsequent treatment; time to treatment discontinuation or death; overall survival; safety; and tolerability. Primary analysis was planned 18 months after the last patient was enrolled; the data cutoff date was October 2, 2020.

A total of 279 patients were enrolled in the study. The mean age of the study population was 64 years; the majority (90.7%) had confirmed non-gBRCAm. In the overall study population, the median PFS was 9.2 months; the 12-month PFS rate was 38.5%, and the 18-month PFS rate was 24.3%. The PFS benefit extended to key subgroups evaluated, including those tested by Myriad HRD/BRCAm status (HRD-positive including sBRCAm: 11.1 months; HRD-positive excluding sBRCAm: 9.7 months; sBRCAm: 16.4 months). Median time to first subsequent treatment was 13.9 months.

Treatment-emergent adverse events (TEAEs) were consistent with the known safety profile of olaparib. Grade ≥3 TEAEs occurred in 29.0% of patients, and serious TEAEs occurred in 19.7% of patients. TEAEs led to dose interruption in 47.0% of patients, dose reduction in 22.6% of patients, and treatment discontinuation in 7.5% of patients.

Primary analysis results of the OPINION study support the use of olaparib maintenance therapy in patients with non-gBRCAm platinum-sensitive relapsed ovarian cancer.

Source: Poveda A, Lheureux S, Colombo N, 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 primary analysis. J Clin Oncol. 2021;39(suppl_15). Abstract 5545.

Related Items
How to Sequence Treatment in Relapsed Ovarian Cancer
2021 Year in Review - Ovarian Cancer published on January 18, 2022 in Ovarian Cancer
Maintenance Gemogenovatucel-T Immunotherapy in Newly Diagnosed Advanced Ovarian Cancer
2021 Year in Review - Ovarian Cancer published on January 18, 2022 in Ovarian Cancer
Patient Self-Reporting of Tolerability in Phase 2 Trial Comparing Gemcitabine plus Adavosertib or Placebo in Women with Platinum-Resistant Epithelial Ovarian Cancer
2021 Year in Review - Ovarian Cancer published on January 18, 2022 in Ovarian Cancer
Mirvetuximab Soravtansine plus Bevacizumab in Patients with Recurrent Ovarian Cancer
2021 Year in Review - Ovarian Cancer published on January 18, 2022 in Ovarian Cancer
NeoPembrOV Study of Neoadjuvant Chemotherapy with or without Pembrolizumab Followed by Interval Debulking Surgery and Standard Systemic Therapy with or without Pembrolizumab for Advanced High-Grade Serous Carcinoma
2021 Year in Review - Ovarian Cancer published on January 18, 2022 in Ovarian Cancer
Optimal Treatment Duration of Bevacizumab plus Carboplatin/Paclitaxel in Advanced Ovarian Cancer
2021 Year in Review - Ovarian Cancer published on January 18, 2022 in Ovarian Cancer
Phase 1 Study of GAS6/AXL Inhibitor (AVB-500) in Recurrent, Platinum-Resistant Ovarian Carcinoma
2021 Year in Review - Ovarian Cancer published on January 18, 2022 in Ovarian Cancer
Anlotinib in Combination with TQB2450 in Patients with Recurrent Ovarian Cancer (ACTION)
2021 Year in Review - Ovarian Cancer published on January 18, 2022 in Ovarian Cancer
Niraparib Efficacy and Safety in Patients with BRCA-Mutated Ovarian Cancer from 3 Phase 3 Trials
2021 Year in Review - Ovarian Cancer published on January 18, 2022 in Ovarian Cancer
Real-World Treatment Patterns of Maintenance Therapy in Platinum-Sensitive Recurrent Ovarian Cancer
2021 Year in Review - Ovarian Cancer published on January 18, 2022 in Ovarian Cancer
© Amplity Health. All rights reserved.

Subscribe Today!

To sign up for our newsletter or print publications, please enter your contact information below.

I'd like to receive: