Phase II study of afatinib plus pembrolizumab in patients with squamous cell carcinoma of the lung following progression during or after first-line chemotherapy (LUX-Lung-IO)

Afatinib; Carcinoma, Squamous Cell; Pembrolizumab

Detalles Bibliográficos
Autores: Levy, Benjamin, Barlesi, Fabrice, Paz-Ares, Luis, Bennouna, Jaafar, Erman, Mustafa, Isla, Dolores, Felip Font, Enriqueta
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2022
País:España
Institución:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:11351/7898
Acceso en línea:https://hdl.handle.net/11351/7898
Access Level:acceso abierto
Palabra clave:Pulmons - Càncer - Tractament
Quimioteràpia combinada
Avaluació de resultats (Assistència sanitària)
DISEASES::Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Lung Neoplasms
Other subheadings::Other subheadings::Other subheadings::/drug therapy
ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias torácicas::neoplasias del tracto respiratorio::neoplasias pulmonares
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
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network_name_str España
repository_id_str
dc.title.none.fl_str_mv Phase II study of afatinib plus pembrolizumab in patients with squamous cell carcinoma of the lung following progression during or after first-line chemotherapy (LUX-Lung-IO)
title Phase II study of afatinib plus pembrolizumab in patients with squamous cell carcinoma of the lung following progression during or after first-line chemotherapy (LUX-Lung-IO)
spellingShingle Phase II study of afatinib plus pembrolizumab in patients with squamous cell carcinoma of the lung following progression during or after first-line chemotherapy (LUX-Lung-IO)
Levy, Benjamin
Pulmons - Càncer - Tractament
Quimioteràpia combinada
Avaluació de resultats (Assistència sanitària)
DISEASES::Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Lung Neoplasms
Other subheadings::Other subheadings::Other subheadings::/drug therapy
ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias torácicas::neoplasias del tracto respiratorio::neoplasias pulmonares
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
title_short Phase II study of afatinib plus pembrolizumab in patients with squamous cell carcinoma of the lung following progression during or after first-line chemotherapy (LUX-Lung-IO)
title_full Phase II study of afatinib plus pembrolizumab in patients with squamous cell carcinoma of the lung following progression during or after first-line chemotherapy (LUX-Lung-IO)
title_fullStr Phase II study of afatinib plus pembrolizumab in patients with squamous cell carcinoma of the lung following progression during or after first-line chemotherapy (LUX-Lung-IO)
title_full_unstemmed Phase II study of afatinib plus pembrolizumab in patients with squamous cell carcinoma of the lung following progression during or after first-line chemotherapy (LUX-Lung-IO)
title_sort Phase II study of afatinib plus pembrolizumab in patients with squamous cell carcinoma of the lung following progression during or after first-line chemotherapy (LUX-Lung-IO)
dc.creator.none.fl_str_mv Levy, Benjamin
Barlesi, Fabrice
Paz-Ares, Luis
Bennouna, Jaafar
Erman, Mustafa
Isla, Dolores
Felip Font, Enriqueta
author Levy, Benjamin
author_facet Levy, Benjamin
Barlesi, Fabrice
Paz-Ares, Luis
Bennouna, Jaafar
Erman, Mustafa
Isla, Dolores
Felip Font, Enriqueta
author_role author
author2 Barlesi, Fabrice
Paz-Ares, Luis
Bennouna, Jaafar
Erman, Mustafa
Isla, Dolores
Felip Font, Enriqueta
author2_role author
author
author
author
author
author
dc.contributor.none.fl_str_mv Institut Català de la Salut
[Levy B] Johns Hopkins Sidney Kimmel Cancer Center at Sibley Memorial Hospital, Washington, DC, USA. [Barlesi F] Aix Marseille University, CNRS, INSERM, CRCM, Assistance Publique Hôpitaux de Marseille, Marseille, France. Gustave Roussy Cancer Campus, Villejuif, France. [Paz-Ares L] Department of Medical Oncology, University Hospital 12 De Octubre, Madrid, Spain. [Bennouna J] Department of Pneumology, Thoracic Oncology, University Hospital - Nantes, Nantes, France. [Erman M] Department of Medical Oncology, Hacettepe University Cancer Institute, Ankara, Turkey. [Felip E] Servei d’Oncologia Mèdica, Vall d'Hebron Hospital Universitari, Barcelona, Spain. Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Isla D] Department of Medical Oncology, University Hospital Lozano Blesa, Zaragoza, Spain
Vall d'Hebron Barcelona Hospital Campus
dc.subject.none.fl_str_mv Pulmons - Càncer - Tractament
Quimioteràpia combinada
Avaluació de resultats (Assistència sanitària)
DISEASES::Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Lung Neoplasms
Other subheadings::Other subheadings::Other subheadings::/drug therapy
ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias torácicas::neoplasias del tracto respiratorio::neoplasias pulmonares
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
topic Pulmons - Càncer - Tractament
Quimioteràpia combinada
Avaluació de resultats (Assistència sanitària)
DISEASES::Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Lung Neoplasms
Other subheadings::Other subheadings::Other subheadings::/drug therapy
ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias torácicas::neoplasias del tracto respiratorio::neoplasias pulmonares
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
description Afatinib; Carcinoma, Squamous Cell; Pembrolizumab
publishDate 2022
dc.date.none.fl_str_mv 2022
2022
2022
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11351/7898
url https://hdl.handle.net/11351/7898
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Lung Cancer;166
https://doi.org/10.1016/j.lungcan.2022.01.023
dc.rights.none.fl_str_mv Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv Scientia
reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869424961079214080
spelling Phase II study of afatinib plus pembrolizumab in patients with squamous cell carcinoma of the lung following progression during or after first-line chemotherapy (LUX-Lung-IO)Levy, BenjaminBarlesi, FabricePaz-Ares, LuisBennouna, JaafarErman, MustafaIsla, DoloresFelip Font, EnriquetaPulmons - Càncer - TractamentQuimioteràpia combinadaAvaluació de resultats (Assistència sanitària)DISEASES::Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Lung NeoplasmsOther subheadings::Other subheadings::Other subheadings::/drug therapyENFERMEDADES::neoplasias::neoplasias por localización::neoplasias torácicas::neoplasias del tracto respiratorio::neoplasias pulmonaresOtros calificadores::Otros calificadores::Otros calificadores::/farmacoterapiaAfatinib; Carcinoma, Squamous Cell; PembrolizumabAfatinib; Carcinoma de células escamosas; PembrolizumabAfatinib; Carcinoma de cèl·lules escamoses; PembrolizumabIntroduction Afatinib and pembrolizumab have separately shown survival benefit in patients with squamous cell carcinoma (SqCC) of the lung, and there is biological rationale for concurrent inhibition of the programmed death ligand-1 and epidermal growth factor receptor (EGFR) pathways in this patient population. Materials and Methods This open-label, single-arm study enrolled patients with SqCC of the lung who had progressed during/after first-line chemotherapy and comprised two parts: a safety run-in to establish the recommended phase II dose (RP2D; afatinib 40 mg or 30 mg once daily with pembrolizumab 200 mg every 3 weeks); and the main part assessing efficacy and safety of the RP2D. The primary endpoint was objective response rate (ORR); secondary endpoints included the RP2D, progression-free survival (PFS) and overall survival (OS). Results Twenty-four patients were treated in the safety run-in (afatinib 40 mg/30 mg cohorts: n = 12/12). Median age was 63.5 years; 79.2% of patients were male. All patients discontinued afatinib and pembrolizumab, most commonly due to disease progression (58.3% and 75.0%, respectively) or adverse events (AEs; 37.5% and 25.0%, respectively). The study was discontinued early after completion of the safety run-in, and no patients entered the main part. ORR was 12.5%; median PFS and OS were 13.1 and 29.3 weeks, respectively. All patients had ≥ 1 drug-related AE (grade ≥ 3: 45.8%). Conclusion While there were no new or unexpected safety findings, exploratory analysis of antitumor activity indicated limited efficacy with afatinib plus pembrolizumab in patients with SqCC of the lung who had progressed during/after first-line chemotherapy.This work was supported by Boehringer Ingelheim International GmbH and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Both study sponsors participated in the design of the study, the collection, analysis, and interpretation of the data, writing this article, and the decision to submit the article for publication.ElsevierInstitut Català de la Salut[Levy B] Johns Hopkins Sidney Kimmel Cancer Center at Sibley Memorial Hospital, Washington, DC, USA. [Barlesi F] Aix Marseille University, CNRS, INSERM, CRCM, Assistance Publique Hôpitaux de Marseille, Marseille, France. Gustave Roussy Cancer Campus, Villejuif, France. [Paz-Ares L] Department of Medical Oncology, University Hospital 12 De Octubre, Madrid, Spain. [Bennouna J] Department of Pneumology, Thoracic Oncology, University Hospital - Nantes, Nantes, France. [Erman M] Department of Medical Oncology, Hacettepe University Cancer Institute, Ankara, Turkey. [Felip E] Servei d’Oncologia Mèdica, Vall d'Hebron Hospital Universitari, Barcelona, Spain. Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Isla D] Department of Medical Oncology, University Hospital Lozano Blesa, Zaragoza, SpainVall d'Hebron Barcelona Hospital Campus202220222022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/11351/7898Scientiareponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésLung Cancer;166https://doi.org/10.1016/j.lungcan.2022.01.023Attribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:11351/78982026-05-29T05:05:01Z
score 15,812455

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