Recurrent ovarian cancer: nivolumab plus ipilimumab shows response in phase 2

  • Zamarin D & al.
  • J Clin Oncol
  • 10 Apr 2020

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • In patients with recurrent/persistent ovarian cancer, induction treatment with nivolumab+ipilimumab followed by nivolumab maintenance showed superior response and PFS benefit with manageable toxicities vs nivolumab alone.
  • The response was not durable in most patients.

Why this matters

  • Further exploration of the ipilimumab+nivolumab regimen, possibly in combination with other agents, is warranted.

Study design

  • Phase 2 study: 100 patients with recurrent/persistent ovarian cancer and a platinum-free interval (PFI) of
  • Funding: National Cancer Institute.

Key results

  • The PFI was
  • In the nivolumab-alone group vs the nivolumab+ipilimumab group:
    • At 6 months, the objective response rate was 12.2% vs 31.4% (OR, 3.28; P=.034).
    • Stable disease rate was 29% vs 39%.
    • Response duration of ≥6 months without evidence of new disease was 8.2% vs 15.7%.
    • Median PFS was 2.0 vs 3.9 months (HR, 0.528; P=.004).
    • Median OS was not significantly different (HR, 0.789; P=.43).
    • Grade ≥3 adverse event rate was 55.1% vs 66.7% (P=.31).
  • 1 death was reported in the combination group.
  • No significant association was observed between PFS and programmed death-ligand 1 expression.

Limitations

  • Open-label design.
  • Limited power for biomarker analysis.