In COSMIC-313 trial presented by Dr. Toni Choueiri, #cabozantinib (C) in combination with #nivolumab (N) and #ipilimumab (I) improved PFS compared to nivolumab (N) and ipilimumab (I) in previously untreated advanced renal cell carcinoma (#RCC) of IMDC intermediate or poor risk. In this phase III, randomized trial, 855 pts were randomized 1:1 to either C+N+I or N+I.

The study met the primary PFS endpoint (HR 0.73, 95% CI, 0.57–0.94; p=0.013); median PFS was not reached (NR) for C+N+I vs 11.3 mo for N+I. ORR was 43% for C+N+I vs 36% for P+N+I. Grade 3/4 TRAEs occurred in 73% with C+N+I vs 41% with N+I; 3 pts (1%) in each arm had grade 5 TRAEs, and a TRAE led to discontinuation of all treatment components in 12% vs 5%.