Nivolumab versus everolimus in advanced renal cell carcinoma: Japanese subgroup 3-year follow-up analysis from the Phase III CheckMate 025 study

Yoshihiko Tomita, Satoshi Fukasawa, Nobuo Shinohara, Hiroshi Kitamura, Mototsugu Oya, Masatoshi Eto, Kazunari Tanabe, Mitsuru Saito, Go Kimura, Junji Yonese, Masahiro Yao, Hirotsugu Uemura

Research output: Contribution to journalArticle

Abstract

Background: Nivolumab treatment resulted in superior efficacy and safety versus everolimus treatment in the 2-year follow-up of the CheckMate 025 Phase III study, with consistent results in the global population and the Japanese population. Here, we report the 3-year follow-up in both groups. Methods: Patients were randomized 1:1 to nivolumab 3 mg/kg intravenously every 2 weeks or everolimus 10 mg orally once daily until progression/intolerable toxicity. The primary endpoint was overall survival (OS). Key secondary endpoints included objective response rate, progressionfree survival, safety and patient-reported quality of life. Results: Of 410 and 411 patients randomized to nivolumab and everolimus, 37 and 26 were Japanese, respectively. The median OS for the global population was 25.8 months with nivolumab and 19.7 months with everolimus (hazard ratio 0.74; 95.5% confidence interval [CI]: 0.63-0.88; P = 0.0005); in the Japanese population, median OS was 45.9 months and not reached (hazard ratio 1.08; 95% CI: 0.50-2.34; P = 0.85), respectively. The investigator-Assessed objective response rate was 26% versus 5% with nivolumab versus everolimus (odds ratio [OR] 6.19; 95% CI: 3.82-10.06) in the global population and 43% versus 8% in the Japanese population (OR 6.80; 95% CI: 1.60-28.91; P = 0.0035), respectively. The incidence of any-grade treatment-related adverse events was lower with nivolumab versus everolimus in both the global patient population (80% versus 89%) and the Japanese population (81% versus 100%). Conclusions: At the 3-year follow-up, the efficacy and safety results of CheckMate 025 are generally consistent in the global and the Japanese populations.

Original languageEnglish
Pages (from-to)506-514
Number of pages9
JournalJapanese journal of clinical oncology
Volume49
Issue number6
DOIs
Publication statusPublished - May 29 2019

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Renal Cell Carcinoma
Population
Confidence Intervals
Survival
Odds Ratio
Safety
Everolimus
nivolumab
Patient Safety
Therapeutics
Survival Rate
Quality of Life
Research Personnel
Incidence

All Science Journal Classification (ASJC) codes

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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Nivolumab versus everolimus in advanced renal cell carcinoma : Japanese subgroup 3-year follow-up analysis from the Phase III CheckMate 025 study. / Tomita, Yoshihiko; Fukasawa, Satoshi; Shinohara, Nobuo; Kitamura, Hiroshi; Oya, Mototsugu; Eto, Masatoshi; Tanabe, Kazunari; Saito, Mitsuru; Kimura, Go; Yonese, Junji; Yao, Masahiro; Uemura, Hirotsugu.

In: Japanese journal of clinical oncology, Vol. 49, No. 6, 29.05.2019, p. 506-514.

Research output: Contribution to journalArticle

Tomita, Y, Fukasawa, S, Shinohara, N, Kitamura, H, Oya, M, Eto, M, Tanabe, K, Saito, M, Kimura, G, Yonese, J, Yao, M & Uemura, H 2019, 'Nivolumab versus everolimus in advanced renal cell carcinoma: Japanese subgroup 3-year follow-up analysis from the Phase III CheckMate 025 study', Japanese journal of clinical oncology, vol. 49, no. 6, pp. 506-514. https://doi.org/10.1093/jjco/hyz026
Tomita, Yoshihiko ; Fukasawa, Satoshi ; Shinohara, Nobuo ; Kitamura, Hiroshi ; Oya, Mototsugu ; Eto, Masatoshi ; Tanabe, Kazunari ; Saito, Mitsuru ; Kimura, Go ; Yonese, Junji ; Yao, Masahiro ; Uemura, Hirotsugu. / Nivolumab versus everolimus in advanced renal cell carcinoma : Japanese subgroup 3-year follow-up analysis from the Phase III CheckMate 025 study. In: Japanese journal of clinical oncology. 2019 ; Vol. 49, No. 6. pp. 506-514.
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abstract = "Background: Nivolumab treatment resulted in superior efficacy and safety versus everolimus treatment in the 2-year follow-up of the CheckMate 025 Phase III study, with consistent results in the global population and the Japanese population. Here, we report the 3-year follow-up in both groups. Methods: Patients were randomized 1:1 to nivolumab 3 mg/kg intravenously every 2 weeks or everolimus 10 mg orally once daily until progression/intolerable toxicity. The primary endpoint was overall survival (OS). Key secondary endpoints included objective response rate, progressionfree survival, safety and patient-reported quality of life. Results: Of 410 and 411 patients randomized to nivolumab and everolimus, 37 and 26 were Japanese, respectively. The median OS for the global population was 25.8 months with nivolumab and 19.7 months with everolimus (hazard ratio 0.74; 95.5{\%} confidence interval [CI]: 0.63-0.88; P = 0.0005); in the Japanese population, median OS was 45.9 months and not reached (hazard ratio 1.08; 95{\%} CI: 0.50-2.34; P = 0.85), respectively. The investigator-Assessed objective response rate was 26{\%} versus 5{\%} with nivolumab versus everolimus (odds ratio [OR] 6.19; 95{\%} CI: 3.82-10.06) in the global population and 43{\%} versus 8{\%} in the Japanese population (OR 6.80; 95{\%} CI: 1.60-28.91; P = 0.0035), respectively. The incidence of any-grade treatment-related adverse events was lower with nivolumab versus everolimus in both the global patient population (80{\%} versus 89{\%}) and the Japanese population (81{\%} versus 100{\%}). Conclusions: At the 3-year follow-up, the efficacy and safety results of CheckMate 025 are generally consistent in the global and the Japanese populations.",
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T1 - Nivolumab versus everolimus in advanced renal cell carcinoma

T2 - Japanese subgroup 3-year follow-up analysis from the Phase III CheckMate 025 study

AU - Tomita, Yoshihiko

AU - Fukasawa, Satoshi

AU - Shinohara, Nobuo

AU - Kitamura, Hiroshi

AU - Oya, Mototsugu

AU - Eto, Masatoshi

AU - Tanabe, Kazunari

AU - Saito, Mitsuru

AU - Kimura, Go

AU - Yonese, Junji

AU - Yao, Masahiro

AU - Uemura, Hirotsugu

PY - 2019/5/29

Y1 - 2019/5/29

N2 - Background: Nivolumab treatment resulted in superior efficacy and safety versus everolimus treatment in the 2-year follow-up of the CheckMate 025 Phase III study, with consistent results in the global population and the Japanese population. Here, we report the 3-year follow-up in both groups. Methods: Patients were randomized 1:1 to nivolumab 3 mg/kg intravenously every 2 weeks or everolimus 10 mg orally once daily until progression/intolerable toxicity. The primary endpoint was overall survival (OS). Key secondary endpoints included objective response rate, progressionfree survival, safety and patient-reported quality of life. Results: Of 410 and 411 patients randomized to nivolumab and everolimus, 37 and 26 were Japanese, respectively. The median OS for the global population was 25.8 months with nivolumab and 19.7 months with everolimus (hazard ratio 0.74; 95.5% confidence interval [CI]: 0.63-0.88; P = 0.0005); in the Japanese population, median OS was 45.9 months and not reached (hazard ratio 1.08; 95% CI: 0.50-2.34; P = 0.85), respectively. The investigator-Assessed objective response rate was 26% versus 5% with nivolumab versus everolimus (odds ratio [OR] 6.19; 95% CI: 3.82-10.06) in the global population and 43% versus 8% in the Japanese population (OR 6.80; 95% CI: 1.60-28.91; P = 0.0035), respectively. The incidence of any-grade treatment-related adverse events was lower with nivolumab versus everolimus in both the global patient population (80% versus 89%) and the Japanese population (81% versus 100%). Conclusions: At the 3-year follow-up, the efficacy and safety results of CheckMate 025 are generally consistent in the global and the Japanese populations.

AB - Background: Nivolumab treatment resulted in superior efficacy and safety versus everolimus treatment in the 2-year follow-up of the CheckMate 025 Phase III study, with consistent results in the global population and the Japanese population. Here, we report the 3-year follow-up in both groups. Methods: Patients were randomized 1:1 to nivolumab 3 mg/kg intravenously every 2 weeks or everolimus 10 mg orally once daily until progression/intolerable toxicity. The primary endpoint was overall survival (OS). Key secondary endpoints included objective response rate, progressionfree survival, safety and patient-reported quality of life. Results: Of 410 and 411 patients randomized to nivolumab and everolimus, 37 and 26 were Japanese, respectively. The median OS for the global population was 25.8 months with nivolumab and 19.7 months with everolimus (hazard ratio 0.74; 95.5% confidence interval [CI]: 0.63-0.88; P = 0.0005); in the Japanese population, median OS was 45.9 months and not reached (hazard ratio 1.08; 95% CI: 0.50-2.34; P = 0.85), respectively. The investigator-Assessed objective response rate was 26% versus 5% with nivolumab versus everolimus (odds ratio [OR] 6.19; 95% CI: 3.82-10.06) in the global population and 43% versus 8% in the Japanese population (OR 6.80; 95% CI: 1.60-28.91; P = 0.0035), respectively. The incidence of any-grade treatment-related adverse events was lower with nivolumab versus everolimus in both the global patient population (80% versus 89%) and the Japanese population (81% versus 100%). Conclusions: At the 3-year follow-up, the efficacy and safety results of CheckMate 025 are generally consistent in the global and the Japanese populations.

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