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).
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.
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.
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.
Japanese journal of clinical oncology. 2017 Apr 13 [Epub ahead of print]
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
Department of Urology, Yamagata University Hospital, Yamagata., Prostate Center and Division of Urology, Chiba Cancer Center, Chiba., Department of Urology, Hokkaido University, Sapporo., Department of Urology, Sapporo Medical University Hospital, Sapporo., Department of Urology, Keio University Hospital, Tokyo., Department of Urology, Kumamoto University, Kumamoto., Department of Urology, Tokyo Women's Medical University Hospital, Tokyo., Department of Urology, Nippon Medical School Hospital, Tokyo., Department of Urology, Cancer Institute Hospital, Tokyo., Department of Urology, Yokohama City University Hospital, Yokohama, Japan., Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Department of Urology, Kindai University Faculty of Medicine, Osaka, Japan., Global Biometric Sciences, Bristol-Myers Squibb, Princeton, NJ, USA., Global Clinical Research, Bristol-Myers Squibb, Princeton, NJ, USA., Department of Urology, Hamamatsu University School of Medicine, Hamamatsu, Japan.