During a median follow-up of 12.8 months, 89.9% of patient in the pembrolizumab–axitinib group and 78.3% in the sunitinib group were alive at 12 months. Median progression-free survival was 15.1 months and 11.1 months respectively (HR for disease progression or death, 0.69; P<0.001).
A related editorial discusses the outcomes from both this study and the JAVELIN Renal 101 study, highlighting the superiority in primary outcomes when compared to sunitinib, and suggesting that these strategies are expected to become new standards of care and to be incorporated into future guidelines.
The U.S. FDA has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for pembrolizumab in combination with axitinib for the first-line treatment of patients with advanced renal cell carcinoma on the basis of results from this study.