SAN FRANCISCO—Nivolumab monotherapy is superior to everolimus for treating advanced renal cell carcinoma (RCC), according to an updated, final analysis of the phase 3 CheckMate 025 trial presented at the 2020 Genitourinary Cancers Symposium.

The original 2015 trial provided safety and efficacy data with 14 months of minimum follow-up. Robert J. Motzer, MD, of the Memorial Sloan Kettering Cancer Center in New York, and colleagues presented new data with 64 months of minimum follow-up.

In the trial, patients with advanced RCC with mostly clear cell histology previously treated with antiangiogenic therapy were randomly assigned to nivolumab, a programmed death 1 (PD-1) checkpoint inhibitor (3 mg/kg given intravenously every 2 weeks) or everolimus, a mammalian target of rapamycin (mTOR) inhibitor (10 mg orally once daily) until progression or unacceptable toxicity. Median duration of therapy was 5.5 vs 3.7 months, respectively.

Nivolumab’s overall survival (OS) advantage was maintained at 60 months by 27%. A total of 26% of 406 nivolumab users vs 18% of 397 everolimus users were still alive at 60 months. Median OS was 25.8 vs 19.7 mos, respectively. Nivolumab likewise provided longer progression-free survival at 60 months (5% vs 1%, respectively).

The objective response rate per investigator favored nivolumab (23% vs 4% for everolimus) and median duration of response was longer with nivolumab (18.2 vs 14.0 months). While minimal, twice as many nivolumab users enjoyed complete response: 1% vs 0.5%. Among patients responding to treatment, ongoing response was observed in 28% vs 18%.

“This final analysis of Checkmate 025 informs efficacy and tolerability of nivolumab monotherapy with long term follow-up,” Dr Motzer told Renal & Urology News.

Most patients received subsequent systemic anticancer therapy, including 67% of nivolumab recipients (35% proceeded with everolimus and 33% axitinib) and 72% of everolimus recipients (41% axitinib and 26% nivolumab).

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The investigators observed no new safety signals or treatment-related deaths with either drug over 60 months. More everolimus than nivolumab recipients experienced a grade 3/4 treatment-related adverse event (37% vs 21%).

According to responses to the Functional Assessment of Cancer Therapy–Kidney Symptom Index (FKSI), nivolumab was associated with sustained improvement in health-related quality of life.  

Disclosure: This clinical trial was supported by Bristol-Myers Squibb. Please see the original reference for a full list of authors’ disclosures.

References

Motzer RJ, Tykodi SS, Escudier B, et al. F5 years of follow-up in patients with advanced renal cell carcinoma (aRCC) (opens in a new tab)”>inal 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). Presented at the 2020 Genitourinary Cancers Symposium held February 13 to 15 in San Francisco. Abstract 617.

Motzer RJ, Escudier B, McDermott DF, et al. Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med 2015; 373:1803-1813. doi: 10.1056/NEJMoa1510665

This article originally appeared on Renal and Urology News