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Nivolumab plus Gemcitabine-Cisplatin in Advanced Urothelial Carcinoma
Michiel S van der Heijden1, Guru Sonpavde1, Thomas Powles1
1From the Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam (M.S.H.); Medical Oncology, Genitourinary Section, Dana-Farber Cancer Institute, Harvard Medical School, Boston (G.S.); the Department of Genitourinary Oncology, Barts Cancer Institute, Queen Mary University of London, London (T.P.); the Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (A.N.); the Department of Oncology, Bradford Hill Clinical Research Center, Santiago, Chile (M.B.); the Department of Medical Oncology, Sf. Nectarie Oncology Center, Department of Oncology, University of Medicine and Pharmacy, Craiova, Romania (M.S.); the Department of Clinical Oncology, Alexander Fleming Institute, Buenos Aires (J.P.S.); the Second Propedeutic Department of Medicine, National and Kapodistrian University of Athens, Attikon University Hospital, Athens (A.B.); the Department of Urologic Oncology, Hopital Foch, Suresnes, France (P.B.); the Department of Urology, Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); the Department of Oncology, Akershus University Hospital, Lørenskog, Norway (J.O.); Roswell Park Comprehensive Cancer Center, Buffalo (G.C.), and the Department of Medicine, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York (M.D.G.) - both in New York; the Department of Medical Oncology, Ankara University, Ankara, Turkey (Y.Ü.); the Department of Oncology, Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and the Department of Urology, Peking University First Hospital, Beijing (Z.H.) - both in China; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Sevilla, Spain (B.P.V.); Seoul National University Hospital, Seoul, South Korea (J.H.K.); the Department of Urology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan (Y.T.); Bristol Myers Squibb, Princeton, NJ (J.F., L.W., M.Y.P., F.N.); and Bristol Myers Squibb, Boudry, Switzerland (D.P.).
Background:
No new agent has improved overall survival in patients with unresectable or metastatic urothelial carcinoma when added to first-line cisplatin-based chemotherapy.
Methods:
In this phase 3, multinational, open-label trial, we randomly assigned patients with previously untreated unresectable or metastatic urothelial carcinoma either to receive intravenous nivolumab (at a dose of 360 mg) plus gemcitabine-cisplatin (nivolumab combination) every 3 weeks for up to six cycles, followed by nivolumab (at a dose of 480 mg) every 4 weeks for a maximum of 2 years, or to receive gemcitabine-cisplatin alone every 3 weeks for up to six cycles. The primary outcomes were overall and progression-free survival. The objective response and safety were exploratory outcomes.
Results:
A total of 608 patients underwent randomization (304 to each group). At a median follow-up of 33.6 months, overall survival was longer with nivolumab-combination therapy than with gemcitabine-cisplatin alone (hazard ratio for death, 0.78; 95% confidence interval [CI], 0.63 to 0.96; P = 0.02); the median survival was 21.7 months (95% CI, 18.6 to 26.4) as compared with 18.9 months (95% CI, 14.7 to 22.4), respectively. Progression-free survival was also longer with nivolumab-combination therapy than with gemcitabine-cisplatin alone (hazard ratio for progression or death, 0.72; 95% CI, 0.59 to 0.88; P = 0.001). The median progression-free survival was 7.9 months and 7.6 months, respectively. At 12 months, progression-free survival was 34.2% and 21.8%, respectively. The overall objective response was 57.6% (complete response, 21.7%) with nivolumab-combination therapy and 43.1% (complete response, 11.8%) with gemcitabine-cisplatin alone. The median duration of complete response was 37.1 months with nivolumab-combination therapy and 13.2 months with gemcitabine-cisplatin alone. Grade 3 or higher adverse events occurred in 61.8% and 51.7% of the patients, respectively.
Conclusions:
Combination therapy with nivolumab plus gemcitabine-cisplatin resulted in significantly better outcomes in patients with previously untreated advanced urothelial carcinoma than gemcitabine-cisplatin alone. (Funded by Bristol Myers Squibb and Ono Pharmaceutical; CheckMate 901 ClinicalTrials.gov number, NCT03036098.).
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