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 - Tập 24 - Trang 1089-1098 - 2019
Chikara Ohyama1, Takahiro Kojima2, Tsunenori Kondo3, Yoshio Naya4,5, Takamitsu Inoue6, Yoshihiko Tomita7, Masatoshi Eto8,9, Shinichi Hisasue10, Hirotsugu Uemura11, Wataru Obara12, Eiji Kikuchi13, Padmanee Sharma14, Matthew D. Galsky15, Arlene Siefker-Radtke14, Gary Grossfeld16, Sandra Collette16, Kyna Gooden16, Go Kimura17
1Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan
2Department of Urology, University of Tsukuba, Tsukuba, Japan
3Department of Urology, Tokyo Women’s Medical University Medical Center East, Tokyo, Japan
4Department of Urology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
5Department of Urology, Meiji University of Integrative Medicine, Nantan, Japan
6Department of Urology, Akita University School of Medicine, Akita, Japan
7Department of Urology, Niigata University Graduate School of Medicine and Dental Sciences, Niigata, Japan
8Department of Urology, Kumamoto University, Kumamoto, Japan
9Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
10Department of Urology, Chiba-Nishi General Hospital, Matsudo City, Japan
11Department of Urology, Kindai University Faculty of Medicine, Osakasayama, Japan
12Department of Urology, Iwate Medical University, Morioka, Japan
13Department of Urology, Keio University School of Medicine, Tokyo, Japan
14Department of Genitourinary Medical Oncology, MD Anderson Cancer Center, University of Texas, Houston, USA
15Department of Hematology and Oncology, Mount Sinai Medical Center, New York, USA
16Bristol-Myers Squibb, Lawrence Township, USA
17Department of Urology, Nippon Medical School, Tokyo, Japan

Tóm tắt

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. 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. 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. 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.

Tài liệu tham khảo

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International Journal of Clinical Oncology

Tập 24

1089-1098

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