Ovarian cancer: maintenance niraparib delays progression

  • Wu XH & al.
  • Ann Oncol
  • 13 Jan 2021

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Niraparib maintenance treatment is linked to a 68% reduced risk for disease progression or death and to prolonged PFS vs placebo in patients with platinum-sensitive recurrent ovarian cancer.
  • Individualized niraparib dosing is effective and safe.

Why this matters

  • Findings warrant validation of individualized starting dose (ISD) in patients with other ethnicities.

Study design

  • Phase 3 double-blind NORA study, China.
  • 265 patients with platinum-sensitive recurrent ovarian cancer were randomly assigned 2:1 to oral niraparib or matched placebo.
  • 249 patients received ISD after protocol amendment.
  • Funding: Zai Lab.

Key results

  • Median follow-up was 15.8 months.
  • Median PFS was significantly longer with niraparib vs placebo:
    • 18.3 vs 5.4 months.
    • HR: 0.32 (P<.0001>
  • Niraparib was associated with significantly prolonged median PFS in:
    • Patients with germline BRCA mutations:
      • Not reached vs 5.5 months.
      • HR: 0.22 (95% CI, 0.12-0.39).
    • Patients without germline BRCA mutations:
      • 11.1 vs 3.9 months.
      • HR: 0.40 (95% CI, 0.26-0.61).
  • Patients who received an ISD experienced improved PFS with niraparib vs placebo:
    • 18.3 vs 5.4 months.
    • HR: 0.30 (95% CI, 0.21-0.43). 
  • Grade ≥3 treatment-emergent adverse events were higher with niraparib (50.8% vs 19.3%). 
    • The most common were decreased neutrophil count (20.3% vs 8.0%) and anemia (14.7% vs 2.3%).

Limitations

  • Homologous recombination deficiency status not known.