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PFS rates did not differ between treatment arms however, 1- and 2-year PFS rates were higher with pembrolizumab. Median 1- and 2-year OS rates were higher with pembrolizumab (44.2% and 26.9%, respectively) than chemotherapy (29.8% and 14.3%, respectively). Median follow-up as of 26 October 2017 was 27.7 months. A key secondary end point was objective response rate per RECIST v1.1 by BICR.Ī total of 542 patients were enrolled (pembrolizumab, n = 270 chemotherapy, n = 272). Primary end points were OS and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) by blinded independent central radiology review (BICR). Patients were randomly assigned 1 : 1 to receive pembrolizumab or investigator's choice of paclitaxel (175 mg/m2 Q3W), docetaxel (75 mg/m2 Q3W), or vinflunine (320 mg/m2 Q3W). Here we report the long-term safety and efficacy outcomes of KEYNOTE-045.Īdult patients with histologically/cytologically confirmed UC whose disease progressed after first-line, platinum-containing chemotherapy were enrolled. Interim analysis of the phase III KEYNOTE-045 study showed a superior overall survival (OS) benefit of pembrolizumab, a programmed death 1 inhibitor, versus chemotherapy in patients with advanced UC that progressed on platinum-based chemotherapy. Novel second-line treatments are needed for patients with advanced urothelial cancer (UC). 18 Department of Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, USA.17 Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.16 Department of Medical Oncology, Merck & Co., Inc., Kenilworth, USA.15 Department of Medical Oncology, Englander Institute for Precision Medicine, Weill Cornell Medicine, New York-Presbyterian, New York.14 Department of Medical Oncology, Hôpital Saint-Louis, Paris, France.13 Department of Medical Oncology, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, USA.12 Department of Medical Oncology, Westmead Hospital and Macquarie University, Sydney, NSW, Australia.11 Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.10 Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.9 Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA.8 Division of Medical Oncology, Smilow Cancer Hospital at Yale University, New Haven.7 Department of Medical Oncology, Fundación Instituto Valenciano de Oncología, Valencia, Spain.6 Department of Medical Oncology, Comprehensive Cancer Centers of Nevada, Las Vegas, USA.
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5 Department of Medicine and Urology, University of California San Francisco, San Francisco.4 Department of Oncology, Asan Medical Center and University of Ulsan College of Medicine, Seoul, Republic of Korea.3 Department of Medical Oncology, Abramson Cancer Center, Perelman Center for Advanced Medicine, Philadelphia, USA.Electronic address: 2 Department of Medical Oncology, PSMAR-IMIM Research Institute, Barcelona, Spain and Harvard Medical School University, Boston, USA. 1 Department of Surgery/Urology, CHU de Québec-Université Laval, Québec City, Canada.