CheckMate 025: Superiority of nivolumab over everolimus confirmed in advanced RCC
medwireNews: The final 5-year analysis of the CheckMate 025 trial comprising patients with advanced renal cell carcinoma (RCC) confirms the enhanced survival benefits of nivolumab versus everolimus.
In all, 821 patients with – predominantly clear cell – advanced RCC were randomly assigned to receive either nivolumab 3 mg/kg every 2 weeks (n=410) or everolimus 10 mg/day (n=411).
The overall survival (OS) benefit seen with nivolumab at 14 months, and previously reported at the European Cancer Congress in 2015, was maintained at the 5-year follow-up. Nivolumab-treated patients had a significantly longer median OS of 25.8 months compared with 19.7 months for everolimus-treated patients.
This translates to a significant 27% reduced risk for death among patients given nivolumab versus those given everolimus, Robert Motzer (Memorial Sloan Kettering Cancer Center, New York, USA) told delegates at the 2020 Genitourinary Cancers Symposium in San Francisco, California, USA.
Progression-free survival (PFS) also favored nivolumab over everolimus, with respective rates of 5% versus 1% at 5 years, but the difference in the median duration, at a corresponding 4.2 and 4.5 months, did not reach statistical significance.
The objective response rates (ORRs) were 23% for patients given nivolumab and 4% for those given everolimus, at a significant odds ratio of 6.86. The median durations of response were 18.2 and 14.0 months, respectively.
Complete responses were achieved by six patients overall; four in the nivolumab treatment arm and two in the everolimus treatment arm, with ongoing response rates of 28% and 18%, respectively.
Motzer explained that following a protocol amendment after the primary analysis, 65 patients crossed over from everolimus to receive nivolumab instead. From the date of crossover, the ORR was 8% among these patients and the PFS was 7.4 months.
Motzer reported that there were no new safety signals, saying: “The incidence of most [treatment-related adverse] events was low and peaked on the initial 7 months of therapy, after which the incidence declined.”
There were a lower percentage of treatment-related adverse events rates of grade 3–4 among patients receiving nivolumab, at 21% versus 37% among patients receiving everolimus.
Nivolumab was also associated with greater improvement in patient-reported health-related quality of life than everolimus, and Motzer noted that “this was sustained with long-term follow-up.”
Indeed, the improved survival outcomes correlated with these “rapid and sustained” improvements in health-related quality of life, he reported.
Motzer concluded: “Nivolumab continues to show significant overall survival benefit, higher objective response rate, and improved progression-free survival over everolimus with long-term follow-up.”
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This independent news story was supported by an educational grant from Pfizer and Merck KGaA