FDA approves avelumab-axitinib for frontline RCC


  • Deepa Koli
  • Oncology drug update
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Takeaway

  • The FDA has approved avelumab with axitinib for the frontline treatment of advanced renal cell carcinoma (RCC).
  • The recommended regimen is avelumab 800 mg intravenously every 2 weeks with axitinib 5 mg orally twice daily.

Why this matters

  • Patients with advanced RCC now have a frontline option that combines PD-L1 immunotherapy with a well-known vascular endothelial growth factor receptor tyrosine kinase inhibitor.

Study design

  • The approval was based on results of the phase 3, open-label, JAVELIN Renal 101 study of 886 patients with untreated advanced clear-cell RCC randomly assigned to avelumab+axitinib or sunitinib, regardless of PD-L1 tumor expression status.

Key results

  • Avelumab+axitinib significantly improved PFS in patients with PD-L1-positive tumors (HR, 0.61; P=.0001) and total population (HR, 0.69; P=.0002) vs sunitinib.
  • OS data were not mature. 
  • 9% of patients experienced grade 3-4 hepatotoxicity.
  • 7% of patients discontinued avelumab or axitinib resulting from hepatotoxicity.
  • Most common adverse reactions (≥20%) with avelumab+axitinib were diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain, and headache.

Prescribing Information, click  here .

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