- 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.
- 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.
- 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 .