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The phase III CheckMate-025 trial examined whether nivolumab or everolimus was better in second-line treatment of clear cell metastatic renal cell carcinoma (RCC). The results, which were presented at the 2015 European Cancer Congress, showed an overall survival of 25.0 months with nivolumab versus 19.6 months with everolimus. Nivolumab was also well tolerated, notes Susanne Osanto, MD. However, the progression-free survival (PFS) was similar between the two agents. Responses with immunotherapy are somewhat delayed compared with chemotherapy but may continue after treatment is stopped, she notes.
The Check-Mate-025 trial demonstrated that PD-1 inhibition is active in RCC, states Bernard Escudier, MD. As a result of this study, nivolumab will become a standard of care, he believes. The data, so far, show that PD-L1 expression, notes Escudier, is not a reliable predictive marker in RCC. Studies are ongoing that are evaluating frontline nivolumab in combination with another agent, such as a tyrosine kinase inhibitor or another checkpoint inhibitor.