Phase 1/2 study of the safety and clinical activity of durvalumab in patients with non-small cell lung cancer (NSCLC)

© 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: High PD-L1 expression in lung tumors is associated with response to PD-L1-targeted treatment. Du...

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Main Authors: Antonia, Scott J. (Author) , Jäger, Dirk (Author)
Format: Article (Journal)
Language:English
Published: 11 October 2016
In: Annals of oncology
Year: 2016, Volume: 27
ISSN:1569-8041
DOI:10.1093/annonc/mdw383.16
Online Access:Verlag, kostenfrei, Volltext: http://dx.doi.org/10.1093/annonc/mdw383.16
Verlag, kostenfrei, Volltext: https://academic.oup.com/annonc/article/27/suppl_6/1216PD/2800089
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Author Notes:S.J. Antonia, J.R. Brahmer, S. Khleif, A.S. Balmanoukian, S.-H.I. Ou, M. Gutierrez, D.-W. Kim, S.-W. Kim, M.-J. Ahn, J. Leach, R. Jamal, D. Jaeger, G. Jerusalem, X. Jin, A. Gupta, J. Antal, N.H. Segal
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Summary:© 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: High PD-L1 expression in lung tumors is associated with response to PD-L1-targeted treatment. Durvalumab, an anti-PD-L1 monoclonal antibody, was evaluated in patients with advanced solid tumors, including NSCLC, in a Phase 1/2 multicenter, open-label study (NCT01693562).Methods: Patients received durvalumab 10 mg/kg IV Q2W for up to 12 months or until unacceptable toxicity or disease progression. Safety was evaluated (CTCAE v4.03) through 90 days after last dose; confirmed response (RECIST v1.1) was based on investigator assessment. Retreatment was permitted only upon progression after 12 months of therapy in patients with disease control. Tumor PD-L1 expression was assessed using the Ventana PD-L1 IHC (SP263) assay.Results: As of 29 April 2016, 304 NSCLC patients received durvalumab; 144 (47%) had non-squamous and 160 (53%) had...
Item Description:Gesehen am 09.11.2017
Physical Description:Online Resource
ISSN:1569-8041
DOI:10.1093/annonc/mdw383.16