Veliparib concomitant with first-line chemotherapy and as maintenance therapy in ovarian cancer: Final overall survival and disease-related symptoms results

Eur J Cancer. 2025 Jul 25:225:115587. doi: 10.1016/j.ejca.2025.115587. Epub 2025 Jun 17.

Abstract

Introduction: In the VELIA trial, the addition of veliparib to standard first-line platinum-based chemotherapy and continued as maintenance resulted in significantly longer median progression-free survival (PFS) compared with carboplatin plus paclitaxel induction therapy alone (23.5 vs 17.3 months; p < 0.001) in patients with ovarian cancer. We now report final overall survival (OS) and updated safety and disease-related symptoms (DRS) from patient-reported outcomes of the trial.

Methods: This randomized, placebo-controlled, double-blind, multicenter, phase 3 study enrolled adult women with an initial diagnosis of stage III/IV high-grade serous ovarian cancer undergoing primary or interval cytoreductive surgery. Patients were randomized 1:1:1 to chemotherapy plus veliparib followed by veliparib maintenance (veliparib-throughout), chemotherapy plus veliparib followed by placebo maintenance (veliparib-combination-only), or chemotherapy plus placebo followed by placebo maintenance (placebo-throughout). PFS was the primary endpoint; OS and DRS were secondary endpoints.

Results: In the intention-to-treat population (N = 1140), median OS was 59.2 months (95 % confidence interval: 52.1, 68.2) for the veliparib-throughout group, 58.0 (50.6, 64.1) months for veliparib-combination-only, and 57.8 (52.3, 63.8) months for placebo-throughout. OS outcomes were not significantly different between arms overall or in the BRCA-deficient and homologous recombination-deficient cohorts. No new safety signals were identified during the longer follow-up period and DRS analyses indicated there was no significant additional symptom-related burden overall when veliparib was added to chemotherapy or used for maintenance.

Conclusion: No OS or DRS benefit of addition of veliparib to platinum-based chemotherapy and continued as maintenance therapy was detected in this study, despite an observed benefit over chemotherapy alone in PFS.

Keywords: Maintenance; Ovarian cancer; Overall survival; PARP inhibitor; Phase 3 trial; Veliparib.

Publication types

  • Randomized Controlled Trial
  • Clinical Trial, Phase III
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols* / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols* / therapeutic use
  • Benzimidazoles* / administration & dosage
  • Benzimidazoles* / adverse effects
  • Benzimidazoles* / therapeutic use
  • Carboplatin / administration & dosage
  • Double-Blind Method
  • Female
  • Humans
  • Maintenance Chemotherapy
  • Middle Aged
  • Ovarian Neoplasms* / drug therapy
  • Ovarian Neoplasms* / mortality
  • Ovarian Neoplasms* / pathology
  • Paclitaxel / administration & dosage
  • Progression-Free Survival

Substances

  • veliparib
  • Benzimidazoles
  • Carboplatin
  • Paclitaxel