Veliparib delays progression in advanced ovarian cancer

  • Coleman RL & al.
  • N Engl J Med
  • 28 Sep 2019

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Veliparib added to frontline induction chemotherapy and continued as single-agent maintenance therapy significantly improves PFS vs chemotherapy alone in advanced high-grade serous ovarian cancer.

Why this matters

  • Together with data for niraparib, findings support PARP inhibitors as the new frontline standard of care.

Study design

  • Multinational, phase 3 placebo-controlled double-blind trial of 1140 patients with advanced-stage high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
  • Patients were randomly assigned 1:1:1 to chemotherapy-only (carboplatin+paclitaxel), veliparib+chemotherapy, or veliparib+chemotherapy with veliparib maintenance (veliparib-throughout).  
  • Funding: AbbVie.

Key results

  • Median duration of follow-up was 28 months.
  • Veliparib-throughout significantly improved median PFS vs chemotherapy-only in the:
    • BRCA-mutation cohort (34.7 vs 22.0 months; HR, 0.44; P<.001>
    • Homologous recombination deficiency cohort (31.9 vs 20.5 months; HR, 0.57; P<.001>
    • Intent-to-treat population (23.5 vs 17.3 months; HR, 0.68; P<.001>
  • Veliparib+chemotherapy only did not significantly boost PFS vs chemotherapy-only.
  • The most common grade 3/4 adverse events in:
    • Veliparib-throughout vs chemotherapy-only: neutropenia (58% vs 49%), anemia (38% vs 26%), thrombocytopenia (28% vs 8%), and leukopenia (18% vs 9%).
    • Veliparib monotherapy: neutropenia (62%), anemia (41%), thrombocytopenia (31%), and leukopenia (12%).

Limitations

  • OS data were immature.

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