Belzutifan plus lenvatinib versus cabozantinib in patients with previously treated advanced renal cell carcinoma (LITESPARK-011): an open-label, randomised, controlled, phase 3 trial

The phase 3 LITESPARK-011 trial showed that the combination of belzutifan plus lenvatinib is an efficacious treatment option for patients with advanced clear-cell renal cell carcinoma who progressed after anti-PD-1 or anti-PD-L1 therapy, compared with cabozantinib. Although overall survival did not reach statistical significance between the two arms, the combination demonstrated sufficient clinical benefit to potentially establish a new standard of care in this second-line setting. The safety profile of belzutifan–lenvatinib was consistent with the known toxicities of each individual agent.