Yoshihiko Tomita1,2, Satoshi Fukasawa3, Nobuo Shinohara4, Hiroshi Kitamura5,6, Mototsugu Oya7, Masatoshi Eto8,9, Kazunari Tanabe10, Mitsuru Saito11, Go Kimura12, Junji Yonese13, Masahiro Yao14, Hirotsugu Uemura15. 1. Current affiliation: Department of Urology, Molecular Oncology, Graduate School of Medical and Dental Sciences, Niigata University, Niigata. 2. Department of Urology, Yamagata University Hospital, Yamagata. 3. Prostate Center and Division of Urology, Chiba Cancer Center, Chiba. 4. Department of Urology, Hokkaido University, Sapporn. 5. Current affiliation: Department of Urology, University of Toyama, Toyama. 6. Department of Urology, Sapporo Medical University Hospital, Sapporo. 7. Department of Urology, Keio University Hospital, Tokyo. 8. Current affiliation: Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka. 9. Department of Urology, Kumamoto University, Kumamoto. 10. Department of Urology, Tokyo Women's Medical University Hospital, Tokyo. 11. Department of Urology, Akita University Hospital, Akita. 12. Department of Urology, Nippon Medical School Hospital, Tokyo. 13. Department of Urology, Cancer Institute Hospital, Tokyo. 14. Department of Urology, Yokohama City University Hospital, Yokohama. 15. Department of Urology, Kindai University Faculty of Medicine, Osaka, Japan.
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, progression-free survival, safety and patient-reported quality of life. RESULTS:Of 410 and 411 patients randomized tonivolumab 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.
RCT Entities:
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, progression-free 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.