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.
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