ASCO-GU 2019—Avelumab+axitinib bests sunitinib in previously untreated clear-cell aRCC

  • Melissa Pandika
  • Univadis
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  • Avelumab plus axitinib led to longer PFS and a higher objective response rate (ORR) than sunitinib, regardless of prognostic risk group and programmed death-ligand 1 (PD-L1) status, in previously untreated patients with clear-cell advanced renal cell carcinoma (aRCC).

Why this matters

  • Supports avelumab+axitinib as first-line standard of care for aRCC.

Study design

  • Analysis of risk groups, other key subgroups in ongoing JAVELIN Renal 101 phase 3 trial.
  • 886 patients with treatment-naive clear-cell aRCC randomly assigned 1:1 to avelumab (10 mg/kg every 2 weeks) + axitinib (5 mg twice/day, 6-week cycle), or sunitinib (50 mg once/day for 4-week-on/2-week-off schedule).
  • Primary endpoint: PFS (RECIST v1.1 by independent review).
  • Funding: Pfizer. 

Key results

  • Median follow-up (months):
    • Avelumab+axitinib: 12.0;
    • Sunitinib: 11.5.
  • PFS by IMDC risk group (months):
    • Favorable 
      • Avelumab+axitinib: not reached;
      • Sunitinib: 13.8.
    • Intermediate
      • Avelumab+axitinib: 13.8;
      • Sunitinib: 8.4.
    •   Poor
      • Avelumab+axitinib: 6.0;
      • Sunitinib: 2.9.
  • PFS by PD-L1 subgroup (months):
    • PD-L1+
      • Avelumab+axitinib: 13.8;
      • Sunitinib: 7.2.
    • PD-L1-
      • Avelumab+axitinib: 16.1;
      • Sunitinib: 11.1.
    • Unknown
      • Avelumab+axitinib: 9.9;
      • Sunitinib: 8.4.
  • Avelumab+axitinib PFS benefit across MSKCC risk groups, as well.
  • Avelumab+axitinib ORR benefit across same risk groups, PD-L1 subgroups.


  • OS data pending.
  • Avelumab+axitinib would likely require more clinical visits than sunitinib.
  • This therapy is, and will remain, inaccessible to most patients worldwide.

Expert comment

  • “Really, the results speak for themselves….They are practice-changing studies,”  said Lori Wood, MD, medical oncologist, associate professor in the Division of Medical Oncology at Dalhousie University, who was not involved in the trial, regarding the above findings and those in abstract 543: “Pembrolizumab (pembro) plus axitinib (axi) versus sunitinib as first-line therapy for locally advanced or metastatic renal cell carcinoma (mRCC): phase III KEYNOTE-426 study.”


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