Belzutifan plus lenvatinib extends progression-free survival in previously treated advanced renal cell carcinoma (LITESPARK-011, phase 3)

Belzutifan plus lenvatinib extended progression-free survival but NOT overall survival. In the phase 3 LITESPARK-011 trial (n=747), median PFS was 14.8 versus 10.7 months with cabozantinib (HR 0.70; 95% CI 0.59-0.84), whereas median overall survival of 34.9 versus 27.6 months did not reach significance (HR 0.85; 95% CI 0.68-1.05; one-sided p=0.061). The population was advanced clear-cell renal cell carcinoma progressing after anti-PD-1 or anti-PD-L1 therapy. Grade 3 or worse treatment-emergent adverse events were similarly frequent in both arms (84% vs 83%), most commonly hypertension.