1/3/2024 0 Comments Keynote 426 criticism![]() ![]() Primary endpoints were overall survival and progression-free survival in the intention-to-treat population. Randomisation was done using an interactive voice response system or integrated web response system, and was stratified by International Metastatic Renal Cell Carcinoma Database Consortium risk status and geographical region. Patients were randomly assigned (1:1) to receive 200 mg pembrolizumab intravenously every 3 weeks for up to 35 cycles plus 5 mg axitinib orally twice daily or 50 mg sunitinib monotherapy orally once daily for 4 weeks per 6-week cycle. In the ongoing, randomised, open-label, phase 3 KEYNOTE-426 study, adults (≥18 years old) with treatment-naive, advanced renal cell carcinoma with clear cell histology were enrolled in 129 sites (hospitals and cancer centres) across 16 countries. The exploratory analysis with extended follow-up reported here aims to assess long-term efficacy and safety of pembrolizumab plus axitinib versus sunitinib monotherapy in patients with advanced renal cell carcinoma. The first interim analysis of the KEYNOTE-426 study showed superior efficacy of pembrolizumab plus axitinib over sunitinib monotherapy in treatment-naive, advanced renal cell carcinoma. 19 Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, USA Vanderbilt-Ingram Cancer Center, Nashville, TN, USA.18 Georgetown Lombardi Comprehensive Cancer Center, Washington, DC, USA.15 Osaka City University Hospital, Osaka, Japan.14 University Hospital, Eberhard Karls University Tübingen, Tübingen, Germany.13 Adelaide and Meath Hospital, Dublin, Ireland University College Dublin, Dublin, Ireland.12 Centre Antoine Lacassagne, Université Côte d'Azur, Nice, France.11 Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.10 Sumy State University, Sumy Regional Oncology Center, Sumy Oblast, Ukraine.9 Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic.8 CHU of Québec and Laval University, Québec, QC, Canada.7 Central Clinical Hospital With Outpatient Clinic, Moscow, Russia.6 Russian Scientific Center of Roentgenoradiology, Moscow, Russia.5 Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine, Dnipro, Ukraine.4 The Christie NHS Foundation Trust, Manchester, UK.3 Centre Hospitalier de l'Universitaire de Montréal, Montréal, QC, Canada.Electronic address: 2 Fox Chase Cancer Center, Philadelphia, PA, USA. 1 Barts Health NHS Trust and the Royal Free NHS Foundation Trust, Barts Cancer Institute, and Queen Mary University of London, London UK. ![]()
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