RCC: nivolumab shows long-term OS advantage vs everolimus

  • Motzer RJ & al.
  • Cancer
  • 16 Jul 2020

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Nivolumab in the long term significantly improved OS in previously treated patients with clear cell advanced renal cell carcinoma (RCC) vs everolimus.

Why this matters

  • Findings confirm long-term OS benefit of nivolumab in this setting.

Study design

  • Phase 3 CheckMate 025 trial of 803 previously treated patients with clear cell advanced RCC, randomly assigned to nivolumab or everolimus.
  • Funding: Bristol-Myers Squibb Company; ONO Pharmaceutical Company, Ltd.

Key results

  • Median follow-up was 72 months.
  • OS was significantly longer in the nivolumab group (HR, 0.73; P<.0001>
  • 5-year OS probability was 26% with nivolumab and 18% with everolimus.
  • PFS was significantly improved with nivolumab (HR, 0.84; P=.0331).
  • In nivolumab vs everolimus groups:
    • Objective response rate was 22.9% vs 4.1% (OR, 6.86; P<.0001>
    • Median time to response was 3.5 vs 3.7 months.
    • Median duration of response was 18.2 vs 14.0 months.
  • The treatment-related adverse event rate with nivolumab vs everolimus:
    • Any grade: 80.5% vs 88.9%.
    • Grade 3/4: 21.4% vs 36.8%.
    • Fatigue was the most common adverse event (34.7% vs 34.5%).

Limitations

  • Open label.