Nivolumab versus everolimus in advanced renal cell carcinoma

Japanese subgroup analysis from the CheckMate 025 study

Yoshihiko Tomita, Satoshi Fukasawa, Nobuo Shinohara, Hiroshi Kitamura, Mototsugu Oya, Masatoshi Eto, Kazunari Tanabe, Go Kimura, Junji Yonese, Masahiro Yao, Robert J. Motzer, Hirotsugu Uemura, M. Brent McHenry, Elmer Berghorn, Seiichiro Ozono

Research output: Contribution to journalArticle

17 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)639-646
Number of pages8
JournalJapanese Journal of Clinical Oncology
Volume47
Issue number7
DOIs
Publication statusPublished - 2017 Jul 1

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Renal Cell Carcinoma
Survival
Confidence Intervals
Safety
Population
Odds Ratio
nivolumab
Everolimus
Stomatitis
Hypertriglyceridemia
Tablets
Disease-Free Survival
Anemia
Diarrhea
Quality of Life

Keywords

  • Everolimus
  • Immune checkpoint inhibitor
  • Japanese
  • Nivolumab
  • Renal cell carcinoma

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

Cite this

Nivolumab versus everolimus in advanced renal cell carcinoma : Japanese subgroup analysis from the CheckMate 025 study. / Tomita, Yoshihiko; Fukasawa, Satoshi; Shinohara, Nobuo; Kitamura, Hiroshi; Oya, Mototsugu; Eto, Masatoshi; Tanabe, Kazunari; Kimura, Go; Yonese, Junji; Yao, Masahiro; Motzer, Robert J.; Uemura, Hirotsugu; Brent McHenry, M.; Berghorn, Elmer; Ozono, Seiichiro.

In: Japanese Journal of Clinical Oncology, Vol. 47, No. 7, 01.07.2017, p. 639-646.

Research output: Contribution to journalArticle

Tomita, Y, Fukasawa, S, Shinohara, N, Kitamura, H, Oya, M, Eto, M, Tanabe, K, Kimura, G, Yonese, J, Yao, M, Motzer, RJ, Uemura, H, Brent McHenry, M, Berghorn, E & Ozono, S 2017, 'Nivolumab versus everolimus in advanced renal cell carcinoma: Japanese subgroup analysis from the CheckMate 025 study', Japanese Journal of Clinical Oncology, vol. 47, no. 7, pp. 639-646. https://doi.org/10.1093/jjco/hyx049
Tomita, Yoshihiko ; Fukasawa, Satoshi ; Shinohara, Nobuo ; Kitamura, Hiroshi ; Oya, Mototsugu ; Eto, Masatoshi ; Tanabe, Kazunari ; Kimura, Go ; Yonese, Junji ; Yao, Masahiro ; Motzer, Robert J. ; Uemura, Hirotsugu ; Brent McHenry, M. ; Berghorn, Elmer ; Ozono, Seiichiro. / Nivolumab versus everolimus in advanced renal cell carcinoma : Japanese subgroup analysis from the CheckMate 025 study. In: Japanese Journal of Clinical Oncology. 2017 ; Vol. 47, No. 7. pp. 639-646.
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AU - Kitamura, Hiroshi

AU - Oya, Mototsugu

AU - Eto, Masatoshi

AU - Tanabe, Kazunari

AU - Kimura, Go

AU - Yonese, Junji

AU - Yao, Masahiro

AU - Motzer, Robert J.

AU - Uemura, Hirotsugu

AU - Brent McHenry, M.

AU - Berghorn, Elmer

AU - Ozono, Seiichiro

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N2 - 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.

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