aRCC: front-line avelumab-axitinib tops sunitinib in JAVELIN Renal 101

  • Motzer RJ & al.
  • N Engl J Med
  • 16 Feb 2019

  • curated by Deepa Koli
  • Univadis Clinical Summaries
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

Takeaway

  • Front-line (1L) avelumab+axitinib improved PFS and objective response rate (ORR) vs sunitinib in advanced renal cell carcinoma (aRCC) in the pivotal phase 3 JAVELIN Renal 101 trial.
  • PFS benefit was observed regardless of risk group or positive programmed death-ligand 1 (PD-L1+) status.

Why this matters

  • Both avelumab and pembrolizumab in combination with axitinib have shown superiority over sunitinib and will likely become new 1L standards of care; clinicians will have options to choose from.

Study design

  • 886 patients with aRCC were randomly assigned to receive avelumab+axitinib or sunitinib.
  • Funding: Pfizer and Merck, Darmstadt, Germany.

Key results

  • Median follow-up with avelumab+axitinib and sunitinib:
    • Overall population: 9.9 and 8.4 months, respectively.
    • Patients with PD-L1-positive tumors (n= 560): 11.6 and 10.7 months, respectively.
  • Avelumab+axitinib significantly prolonged median PFS vs sunitinib in:
    • Overall population: 13.8 vs 8.4 months (HR, 0.69; P<.001>
    • Patients with PD-L1+ tumors: 13.8 vs 7.2 months (HR, 0.61; P<.001>
  • PFS benefit was seen across International Metastatic Renal Cell Carcinoma Database Consortium prognostic risk groups.
  • No difference was observed in OS.
  • ORR was 55.2% with avelumab+axitinib and 25.5% with sunitinib in patients with PD-L1-positive tumors.
  • Any grade and grade ≥3 adverse event rates were similar between groups.

Limitations

  • Open-label design.

Please confirm your acceptance

To gain full access to GPnotebook please confirm:

By submitting here you confirm that you have accepted Terms of Use and Privacy Policy of GPnotebook.

Submit