Nivolumab monotherapy in metastatic urothelial cancer (mUC): updated efficacy by subgroups and safety results from the CheckMate 032 study

© The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissionsoup.com.Background: Nivolumab has shown promising efficacy and acceptable safety in an open-label, multicenter phase...

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Hauptverfasser: Rosenberg, Jonathan E. (VerfasserIn) , Jäger, Dirk (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: 11 October 2016
In: Annals of oncology
Year: 2016, Jahrgang: 27
ISSN:1569-8041
DOI:10.1093/annonc/mdw373.12
Online-Zugang:Verlag, kostenfrei, Volltext: http://dx.doi.org/10.1093/annonc/mdw373.12
Verlag, kostenfrei, Volltext: https://academic.oup.com/annonc/article/27/suppl_6/784P/2799521
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Verfasserangaben:J.E. Rosenberg, P. Bono, J. Kim, P. Spiliopoulou, E. Calvo, R. Pillai, P.A. Ott, F. de Braud, M. Morse, D. Le, D. Jaeger, E. Chan, C. Harbison, C.S. Lin, M. Tschaika, A. Azrilevich, P. Sharma

MARC

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520 |a © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissionsoup.com.Background: Nivolumab has shown promising efficacy and acceptable safety in an open-label, multicenter phase I/II study in patients (pts) with mUC after ≥1 prior platinum-based therapy (NCT01928394). Here we report updated efficacy and safety results for the overall population based on additional follow-up and outcomes by differing levels of PD-L1 expression.Methods: Pts with mUC, unselected by PD-L1 expression status, received nivolumab 3 mg/kg IV every 2 wk until progression or discontinuation. Pts who met protocol criteria could continue treatment beyond progression and cross over to nivolumab + ipilimumab. Tumor PD-L1 membrane expression was assessed with Dako PD-L1 immunohistochemical staining. Primary endpoint: objective response rate (ORR; RECIST 1.1); other endpoints: safety, progression-free survival (PFS), overall survival (OS), and duration of response.Results: Of 78... 
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