In patients with previously treated advanced renal cell carcinoma (RCC), nivolumab significantly increases overall survival and response rates compared with everolimus, according to the final updated analysis of the phase 3 CheckMate 025 trial.
A randomized, open-label trial, CheckMate 025 enrolled 821 patients with advanced RCC previously treated with antiangiogenic therapies. Patients were randomized in a 1:1 ratio to receive 3 mg/kg of nivolumab intravenously every two weeks or 10 mg of everolimus orally once daily, until disease progression or unacceptable toxicity. The primary end point was overall survival, with secondary end points of objective response rate, progression-free survival, and safety. Objective response rate and progression-free survival were assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
The study's primary analysis, done at a minimum follow-up of 14 months, found that nivolumab demonstrated superiority compared with everolimus in terms of overall survival, safety, and tolerability. On February 15th at the 2020 Genitourinary Cancers Symposium, the trial's final updated analysis was presented by first author Robert J. Motzer, MD, Head of the Kidney Cancer Section at Memorial Sloan Kettering Cancer Center.
Performed at a minimum follow-up of 64 months, the final analysis reports that nivolumab improved overall survival compared with everolimus (26% vs 18%). Nivolumab also produced a higher objective response rate compared with everolimus (23% vs 4%), as well as a longer median duration of response (18.2 months vs 14 months). Only 21% of patients in the nivolumab group experienced a grade 3/4 treatment-related adverse event, compared with 37% of patients in the everolimus group. Responses are ongoing in 28% of patients receiving nivolumab, compared with 18% of patients receiving everolimus.
"At more than five years' minimum follow-up, response rates and survival remain superior with nivolumab versus everolimus," conclude Dr. Motzer and colleagues. "Long-term follow-up highlights the efficacy and safety of nivolumab monotherapy in patients with advanced RCC."
For More Information
Motzer RJ, Tykodi SS, Escudier B, et al (2020). Final analysis of the CheckMate 025 trial comparing nivolumab (NIVO) versus everolimus (EVE) with >5 years of follow-up in patients with advanced renal cell carcinoma (aRCC). J Clin Oncol (Genitourinary Cancers Symposium Abstracts), 38(suppl_6). Abstract 617.
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