Nivolumab versus everolimus in advanced renal cell carcinoma: Japanese subgroup analysis from the CheckMate 025 study Journal Article


Authors: Tomita, Y.; Fukasawa, S.; Shinohara, N.; Kitamura, H.; Oya, M.; Eto, M.; Tanabe, K.; Kimura, G.; Yonese, J.; Yao, M.; Motzer, R. J.; Uemura, H.; Brent McHenry, M.; Berghorn, E.; Ozono, S.
Article Title: Nivolumab versus everolimus in advanced renal cell carcinoma: Japanese subgroup analysis from the CheckMate 025 study
Abstract: Background: Nivolumab improved overall survival (OS) and objective response rate (ORR) versus everolimus in previously treated patients with advanced renal cell carcinoma in the phase III CheckMate 025 study (minimum follow-up: 14 months). We report efficacy and safety in the global and Japanese populations (minimum follow-up: 26 months).Methods: Patients were randomized 1:1 to receive nivolumab 3 mg/kg intravenously every 2 weeks or everolimus 10-mg tablet orally once daily. Primary endpoint: OS, key secondary endpoints: ORR, progression-free survival and safety. Results: Of 410 (nivolumab) and 411 (everolimus) patients, 37 (9%) and 26 (6%), respectively, were Japanese. Median OS for the global population was 26.0 months (nivolumab) and 19.7 months (everolimus; hazard ratio 0.73 [95% confidence interval [CI]: 0.61-0.88]; P = 0.0006), with medians not reached for Japanese patients. ORR for the global population was 26% (nivolumab) versus 5% (everolimus; odds ratio 6.13; 95% CI: 3.77-9.95); ORR for Japanese patients: 43% versus 8% (odds ratio 9.14; 95% CI: 1.76-88.33). In Japanese patients, any-grade treatment-related adverse events (AEs) occurred in 78% (Grade 3-4, 19%; most common, anemia [5%]) treated with nivolumab and 100% (Grade 3-4, 58%; most common, hypertriglyceridemia [12%]) treated with everolimus; the most common with nivolumab was diarrhea (19%) and with everolimus was stomatitis (77%). Quality of life was stable in the nivolumab arm. Conclusions: With >2 years of follow-up, Japanese patients had a higher response rate with nivolumab versus everolimus that was more pronounced yet consistent with the global population, with median OS not reached, and a favorable safety profile. © The Author 2017.
Keywords: renal cell carcinoma; japanese; everolimus; immune checkpoint inhibitor; nivolumab
Journal Title: Japanese Journal of Clinical Oncology
Volume: 47
Issue: 7
ISSN: 0368-2811
Publisher: Oxford University Press  
Date Published: 2017-07-01
Start Page: 639
End Page: 646
Language: English
DOI: 10.1093/jjco/hyx049
PROVIDER: scopus
PUBMED: 28419248
PMCID: PMC5896687
DOI/URL:
Notes: Article -- Export Date: 2 August 2017 -- Source: Scopus
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  1. Robert Motzer
    923 Motzer