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: | , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
11 October 2016
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| 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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| 245 | 1 | 0 | |a Phase 1/2 study of the safety and clinical activity of durvalumab in patients with non-small cell lung cancer (NSCLC) |c 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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| 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: 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... | ||
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