First-line cabozantinib plus nivolumab and ipilimumab for intermediate or poor risk advanced renal cell carcinoma

The multinational phase 3 COSMIC-313 trial randomized patients with previously untreated intermediate risk or high risk advanced renal cell carcinoma (aRCC) to cabozantinib plus nivolumab and ipilimumab (experimental group) or placebo plus nivolumab and ipilimumab (control group). The probability of progression-free survival at 12 months was 57% in the experimental group versus 49% in the control group (HR 0.73; p=0.01). Grade 3 or 4 adverse events occurred in 79% of the patients in the experimental group and 56% of patients in the control group. The authors conclude that among patients with intermediate risk or high risk aRCC, addition of cabozantinib to first-line nivolumab and ipilimumab resulted in significantly longer PFS and higher frequency of grade 3 or 4 AEs (quick take video summary).