- 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.
- 886 patients with aRCC were randomly assigned to receive avelumab+axitinib or sunitinib.
- Funding: Pfizer and Merck, Darmstadt, Germany.
- 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>
- Open-label design.