RCC: pembrolizumab-axitinib combo extends survival vs sunitinib

  • Powles T & et al.
  • Lancet Oncol
  • 23 oct. 2020

  • Par Deepa Koli
  • Résumés d'articles
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Takeaway

  • In patients with advanced renal cell carcinoma (RCC), first-line pembrolizumab plus axitinib significantly improved survival vs sunitinib alone in an extended follow-up of the phase 3 KEYNOTE-426 trial.

Why this matters

  • Findings support the use of pembrolizumab plus axitinib as standard of care in this setting.

Study design

  • Phase 3 KEYNOTE-426.
  • 861 treatment-naive patients with advanced RCC were randomly assigned to receive pembrolizumab plus axitinib or sunitinib monotherapy.
  • Funding: MSD.

Key results

  • Median follow-up was 30.6 months.
  • Pembrolizumab plus axitinib significantly prolonged survival vs sunitinib:
    • Median OS: not reached vs 35.7 months.
      • HR, 0.68 (P=.0003).
    • Median PFS: 15.4 vs 11.1 months.
      • HR, 0.71 (P<.0001>
  • Confirmed objective response rate was 60% with pembrolizumab+axitinib vs 40% with sunitinib alone.
  • The most frequent (≥10%) treatment-related grade ≥3 adverse events in the pembrolizumab plus axitinib vs sunitinib groups:
    • Hypertension: 22.14% vs 19.76%.
    • Increased alanine aminotransferase: 12.58% vs 2.58%.
    • Diarrhea: 10.72% vs 5.41%.
  • No new safety signals since interim results were reported.

Limitations

  • Open label.