email article Support for approval came from CheckMate-9ER, a phase III trial that randomized 651 previously untreated patients with advanced RCC to either sunitinib (Sutent) alone or the combination of nivolumab, a PD-1-directed checkpoint inhibitor, plus the tyrosine kinase inhibitor cabozantinib, until disease progression or unacceptable toxicity. "This combination of cabozantinib and nivolumab significantly improved key efficacy measures compared to sunitinib -- progression-free survival, overall survival, and objective response rate -- while showing a low rate of treatment discontinuations due to side effects," investigator Toni Choueiri, MD, of Dana-Farber Cancer Institute in Boston, said in a statement. Overall survival was significantly improved with nivolumab (240 mg every 2 weeks delivered intravenously) plus oral cabozantinib (40 mg daily) compared with oral sunitinib at standard dosing, with a median not reached in either study arm (HR 0.60, 95% CI 0.40-0.89).