FDA approves pembrolizumab-axitinib for renal cell carcinoma


  • Deepa Koli
  • Oncology drug update
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Takeaway

  • The FDA has approved pembrolizumab with axitinib for the frontline treatment of advanced renal cell carcinoma (RCC).
  • The recommended regimen is pembrolizumab 200 mg every 3 weeks with axitinib 5 mg orally twice daily.

Why this matters

  • This marks the first approval for pembrolizumab in renal cancer.

Key highlights

  • The approval was based on results of the multicenter, open-label, KEYNOTE‑426 study of 861 patients with advanced clear-cell RCC randomly assigned to frontline pembrolizumab+axitinib or sunitinib, regardless of PD-L1 tumor expression status.
  • Pembrolizumab+axitinib significantly improved 12-month OS (90% vs 78%; HR, 0.53; P<.0001 and median pfs vs months hr p=".0001)" sunitinib.>
  • 20% of patients experienced grade 3-4 hepatotoxicity.
  • 13% of patients discontinued pembrolizumab or axitinib resulting from hepatotoxicity.
  • Most common adverse reactions (≥20%) with pembrolizumab+axitinib were diarrhea, fatigue/asthenia, hypertension, hypothyroidism, decreased appetite, hepatotoxicity, palmar-plantar erythrodysesthesia, nausea, stomatitis/mucosal inflammation, dysphonia, rash, cough, and constipation.

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