First-line avelumab plus axitinib versus sunitinib for advanced renal cell carcinoma: final analysis of JAVELIN Renal 101

The multinational phase 3 JAVELIN Renal 101 trial randomized patients with previously untreated advanced renal cell carcinoma (aRCC) to avelumab plus axitinib (n=442) or sunitinib (n=444). Final analysis of the trial has now been published. At minimum follow-up of 68 months in all patients, the median overall survival was 43.2 months with avelumab-axitinib versus 36.2 months with sunitinib (HR 0.86; p=0.0755) in the PD-L1 positive population and 44.8 months versus 38.9 months in the overall population (HR 0.88; p=0.0669).Progression-free survival remained prolonged with avelumab-axitinib versus sunitinib (12.0% versus 4.4% after 5 years). The objective response rate was 59.7% versus 32.0%, and duration or response 5 years or longer was seen in 16.4% versus 9.2%. Rates of grade 3 or higher treatment-related adverse events were 66.8% with avelumab-axitinib versus 61.5% with sunitinib. The authors conclude that OS analysis favored avelumab-axitinib versus sunitinib but did not reach statistical significance; subsequent treatments may have impacted results.