Nivolumab in patients with unresectable locally advanced or metastatic urothelial carcinoma: CheckMate 275 2-year global and Japanese patient population analyses

Chikara Ohyama, Takahiro Kojima, Tsunenori Kondo, Yoshio Naya, Takamitsu Inoue, Yoshihiko Tomita, Masatoshi Eto, Shinichi Hisasue, Hirotsugu Uemura, Wataru Obara, Eiji Kikuchi, Padmanee Sharma, Matthew D. Galsky, Arlene Siefker-Radtke, Gary Grossfeld, Sandra Collette, Kyna Gooden, Go Kimura

Research output: Contribution to journalArticle

Abstract

Background: Nivolumab has demonstrated antitumor activity and manageable safety in the single-arm, phase II CheckMate 275 study in patients with unresectable locally advanced or metastatic platinum-resistant urothelial carcinoma. We report updated results of the global population and a subanalysis of Japanese patients from this study. Methods: Patients received nivolumab 3 mg/kg intravenously every 2 weeks until progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) confirmed by blinded independent review committee (BIRC) per Response Evaluation Criteria in Solid Tumors v1.1. Secondary endpoints included progression-free survival (PFS) by BIRC and overall survival (OS). Safety was also reported. The minimum follow-up was 21 months. Results: Overall, 270 patients were treated with nivolumab globally; 23 patients were Japanese. In the global and Japanese populations, respectively, ORR per BIRC was 20.4% and 21.7%; median PFS was 1.9 (95% confidence interval [CI] 1.9–2.3) and 3.8 months (95% CI 1.9–7.2); and median OS was 8.6 (95% CI 6.1–11.3) and 21.0 months (95% CI 7.2–not reached). The most common any grade treatment-related adverse events were fatigue (18.1%) and diarrhea (12.2%) in the global population; the most common in the Japanese population were diarrhea (26.1%) and pyrexia (13.0%). Grade 3 or 4 treatment-related adverse events occurred in 61 (22.6%) and seven (30.4%) of the global and Japanese patients, respectively. Conclusions: Nivolumab continues to show antitumor activity and survival in the global population of CheckMate 275. Meaningful clinical benefit was also observed in Japanese patients. No new safety signals were identified.

Original languageEnglish
Pages (from-to)1089-1098
Number of pages10
JournalInternational Journal of Clinical Oncology
Volume24
Issue number9
DOIs
Publication statusPublished - Sep 13 2019

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Carcinoma
Population
Advisory Committees
Confidence Intervals
Safety
Disease-Free Survival
Survival
Diarrhea
nivolumab
Platinum
Fatigue
Fever
Therapeutics

All Science Journal Classification (ASJC) codes

  • Surgery
  • Hematology
  • Oncology

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Nivolumab in patients with unresectable locally advanced or metastatic urothelial carcinoma : CheckMate 275 2-year global and Japanese patient population analyses. / Ohyama, Chikara; Kojima, Takahiro; Kondo, Tsunenori; Naya, Yoshio; Inoue, Takamitsu; Tomita, Yoshihiko; Eto, Masatoshi; Hisasue, Shinichi; Uemura, Hirotsugu; Obara, Wataru; Kikuchi, Eiji; Sharma, Padmanee; Galsky, Matthew D.; Siefker-Radtke, Arlene; Grossfeld, Gary; Collette, Sandra; Gooden, Kyna; Kimura, Go.

In: International Journal of Clinical Oncology, Vol. 24, No. 9, 13.09.2019, p. 1089-1098.

Research output: Contribution to journalArticle

Ohyama, C, Kojima, T, Kondo, T, Naya, Y, Inoue, T, Tomita, Y, Eto, M, Hisasue, S, Uemura, H, Obara, W, Kikuchi, E, Sharma, P, Galsky, MD, Siefker-Radtke, A, Grossfeld, G, Collette, S, Gooden, K & Kimura, G 2019, 'Nivolumab in patients with unresectable locally advanced or metastatic urothelial carcinoma: CheckMate 275 2-year global and Japanese patient population analyses', International Journal of Clinical Oncology, vol. 24, no. 9, pp. 1089-1098. https://doi.org/10.1007/s10147-019-01450-w
Ohyama, Chikara ; Kojima, Takahiro ; Kondo, Tsunenori ; Naya, Yoshio ; Inoue, Takamitsu ; Tomita, Yoshihiko ; Eto, Masatoshi ; Hisasue, Shinichi ; Uemura, Hirotsugu ; Obara, Wataru ; Kikuchi, Eiji ; Sharma, Padmanee ; Galsky, Matthew D. ; Siefker-Radtke, Arlene ; Grossfeld, Gary ; Collette, Sandra ; Gooden, Kyna ; Kimura, Go. / Nivolumab in patients with unresectable locally advanced or metastatic urothelial carcinoma : CheckMate 275 2-year global and Japanese patient population analyses. In: International Journal of Clinical Oncology. 2019 ; Vol. 24, No. 9. pp. 1089-1098.
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abstract = "Background: Nivolumab has demonstrated antitumor activity and manageable safety in the single-arm, phase II CheckMate 275 study in patients with unresectable locally advanced or metastatic platinum-resistant urothelial carcinoma. We report updated results of the global population and a subanalysis of Japanese patients from this study. Methods: Patients received nivolumab 3 mg/kg intravenously every 2 weeks until progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) confirmed by blinded independent review committee (BIRC) per Response Evaluation Criteria in Solid Tumors v1.1. Secondary endpoints included progression-free survival (PFS) by BIRC and overall survival (OS). Safety was also reported. The minimum follow-up was 21 months. Results: Overall, 270 patients were treated with nivolumab globally; 23 patients were Japanese. In the global and Japanese populations, respectively, ORR per BIRC was 20.4{\%} and 21.7{\%}; median PFS was 1.9 (95{\%} confidence interval [CI] 1.9–2.3) and 3.8 months (95{\%} CI 1.9–7.2); and median OS was 8.6 (95{\%} CI 6.1–11.3) and 21.0 months (95{\%} CI 7.2–not reached). The most common any grade treatment-related adverse events were fatigue (18.1{\%}) and diarrhea (12.2{\%}) in the global population; the most common in the Japanese population were diarrhea (26.1{\%}) and pyrexia (13.0{\%}). Grade 3 or 4 treatment-related adverse events occurred in 61 (22.6{\%}) and seven (30.4{\%}) of the global and Japanese patients, respectively. Conclusions: Nivolumab continues to show antitumor activity and survival in the global population of CheckMate 275. Meaningful clinical benefit was also observed in Japanese patients. No new safety signals were identified.",
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T1 - Nivolumab in patients with unresectable locally advanced or metastatic urothelial carcinoma

T2 - CheckMate 275 2-year global and Japanese patient population analyses

AU - Ohyama, Chikara

AU - Kojima, Takahiro

AU - Kondo, Tsunenori

AU - Naya, Yoshio

AU - Inoue, Takamitsu

AU - Tomita, Yoshihiko

AU - Eto, Masatoshi

AU - Hisasue, Shinichi

AU - Uemura, Hirotsugu

AU - Obara, Wataru

AU - Kikuchi, Eiji

AU - Sharma, Padmanee

AU - Galsky, Matthew D.

AU - Siefker-Radtke, Arlene

AU - Grossfeld, Gary

AU - Collette, Sandra

AU - Gooden, Kyna

AU - Kimura, Go

PY - 2019/9/13

Y1 - 2019/9/13

N2 - Background: Nivolumab has demonstrated antitumor activity and manageable safety in the single-arm, phase II CheckMate 275 study in patients with unresectable locally advanced or metastatic platinum-resistant urothelial carcinoma. We report updated results of the global population and a subanalysis of Japanese patients from this study. Methods: Patients received nivolumab 3 mg/kg intravenously every 2 weeks until progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) confirmed by blinded independent review committee (BIRC) per Response Evaluation Criteria in Solid Tumors v1.1. Secondary endpoints included progression-free survival (PFS) by BIRC and overall survival (OS). Safety was also reported. The minimum follow-up was 21 months. Results: Overall, 270 patients were treated with nivolumab globally; 23 patients were Japanese. In the global and Japanese populations, respectively, ORR per BIRC was 20.4% and 21.7%; median PFS was 1.9 (95% confidence interval [CI] 1.9–2.3) and 3.8 months (95% CI 1.9–7.2); and median OS was 8.6 (95% CI 6.1–11.3) and 21.0 months (95% CI 7.2–not reached). The most common any grade treatment-related adverse events were fatigue (18.1%) and diarrhea (12.2%) in the global population; the most common in the Japanese population were diarrhea (26.1%) and pyrexia (13.0%). Grade 3 or 4 treatment-related adverse events occurred in 61 (22.6%) and seven (30.4%) of the global and Japanese patients, respectively. Conclusions: Nivolumab continues to show antitumor activity and survival in the global population of CheckMate 275. Meaningful clinical benefit was also observed in Japanese patients. No new safety signals were identified.

AB - Background: Nivolumab has demonstrated antitumor activity and manageable safety in the single-arm, phase II CheckMate 275 study in patients with unresectable locally advanced or metastatic platinum-resistant urothelial carcinoma. We report updated results of the global population and a subanalysis of Japanese patients from this study. Methods: Patients received nivolumab 3 mg/kg intravenously every 2 weeks until progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) confirmed by blinded independent review committee (BIRC) per Response Evaluation Criteria in Solid Tumors v1.1. Secondary endpoints included progression-free survival (PFS) by BIRC and overall survival (OS). Safety was also reported. The minimum follow-up was 21 months. Results: Overall, 270 patients were treated with nivolumab globally; 23 patients were Japanese. In the global and Japanese populations, respectively, ORR per BIRC was 20.4% and 21.7%; median PFS was 1.9 (95% confidence interval [CI] 1.9–2.3) and 3.8 months (95% CI 1.9–7.2); and median OS was 8.6 (95% CI 6.1–11.3) and 21.0 months (95% CI 7.2–not reached). The most common any grade treatment-related adverse events were fatigue (18.1%) and diarrhea (12.2%) in the global population; the most common in the Japanese population were diarrhea (26.1%) and pyrexia (13.0%). Grade 3 or 4 treatment-related adverse events occurred in 61 (22.6%) and seven (30.4%) of the global and Japanese patients, respectively. Conclusions: Nivolumab continues to show antitumor activity and survival in the global population of CheckMate 275. Meaningful clinical benefit was also observed in Japanese patients. No new safety signals were identified.

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