Safety and clinical activity of atezolizumab plus erlotinib in patients with non-small-cell lung cancer.

BACKGROUND: Acquired resistance limits long-term epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) efficacy in patients with EGFR mutation-positive non-small-cell lung cancer (NSCLC) in whom anti-programmed death-ligand 1 (PD-L1) efficacy is also limited. We hypothesized that c...

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Autores: Rudin, C M, Cervantes, A, Dowlati, A, Besse, B, Ma, B, Costa, D B, Schmid, P, Heist, R, Villaflor, V M, Spahn, J, Li, S, Cha, E, Riely, G J, Gettinger, S
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2023
País:España
Institución:INCLIVA
Repositorio:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
OAI Identifier:oai:incliva.fundanetsuite.com:p17343
Acceso en línea:https://incliva.portalinvestigacion.com/publicaciones/17343
Access Level:acceso abierto
Palabra clave:EGFR-mutant NSCLC
PD-L1 inhibitor
immune checkpoint inhibitor
tyrosine kinase inhibitor
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spelling Safety and clinical activity of atezolizumab plus erlotinib in patients with non-small-cell lung cancer.Rudin, C MCervantes, ADowlati, ABesse, BMa, BCosta, D BSchmid, PHeist, RVillaflor, V MSpahn, JLi, SCha, ERiely, G JGettinger, SEGFR-mutant NSCLCPD-L1 inhibitorimmune checkpoint inhibitortyrosine kinase inhibitorBACKGROUND: Acquired resistance limits long-term epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) efficacy in patients with EGFR mutation-positive non-small-cell lung cancer (NSCLC) in whom anti-programmed death-ligand 1 (PD-L1) efficacy is also limited. We hypothesized that combining atezolizumab with erlotinib could enhance antitumor immunity and extend efficacy in these patients.; PATIENTS AND METHODS: This open-label phase Ib trial was conducted in adults aged =18 years who had advanced, unresectable NSCLC. Stage 1 (safety evaluation) enrolled EGFR TKI-naive patients regardless of EGFR status. Stage 2 (expansion) enrolled patients with EGFR-mutant NSCLC treated with =1 prior non-EGFR TKI therapy. Patients received 150 mg erlotinib orally once daily. After a 7-day erlotinib run-in, atezolizumab 1200 mg was administered intravenously every 3 weeks. The primary endpoint was the safety and tolerability of the combination in all patients; secondary endpoints included antitumor activity per RECIST 1.1 in stage 2 patients.; RESULTS: At the data cut-off on 7 May 2020, 28 patients (8 in stage 1, 20 in stage 2) were assessable for safety. No dose-limiting toxicities or grade 4 or 5 treatment-related adverse events occurred. Grade 3 treatment-related adverse events occurred in 46% of patients; the most common were increased alanine aminotransferase, diarrhea, pyrexia, and rash (each in 7% of patients). Serious adverse events occurred in 50% of patients. Pneumonitis (grade 1) was reported in a single patient (4%). The objective response rate was 75% [95% confidence interval (CI) 50.9% to 91.3%]), median response duration was 18.9 months (95% CI 9.5-40.5 months), median progression-free survival was 15.4 months (95% CI 8.4-39.0 months), and median overall survival was not estimable (NE) (95% CI 34.6-NE).; CONCLUSIONS: Atezolizumab combined with erlotinib demonstrated a tolerable safety profile and encouraging, durable clinical activity in patients with advanced EGFR mutation-positive NSCLC. Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.ELSEVIER2023info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://incliva.portalinvestigacion.com/publicaciones/17343ESMO OpenISSN: 20597029reponame:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVAinstname:INCLIVAInglésinfo:eu-repo/semantics/openAccessoai:incliva.fundanetsuite.com:p173432026-06-07T16:35:31Z
dc.title.none.fl_str_mv Safety and clinical activity of atezolizumab plus erlotinib in patients with non-small-cell lung cancer.
title Safety and clinical activity of atezolizumab plus erlotinib in patients with non-small-cell lung cancer.
spellingShingle Safety and clinical activity of atezolizumab plus erlotinib in patients with non-small-cell lung cancer.
Rudin, C M
EGFR-mutant NSCLC
PD-L1 inhibitor
immune checkpoint inhibitor
tyrosine kinase inhibitor
title_short Safety and clinical activity of atezolizumab plus erlotinib in patients with non-small-cell lung cancer.
title_full Safety and clinical activity of atezolizumab plus erlotinib in patients with non-small-cell lung cancer.
title_fullStr Safety and clinical activity of atezolizumab plus erlotinib in patients with non-small-cell lung cancer.
title_full_unstemmed Safety and clinical activity of atezolizumab plus erlotinib in patients with non-small-cell lung cancer.
title_sort Safety and clinical activity of atezolizumab plus erlotinib in patients with non-small-cell lung cancer.
dc.creator.none.fl_str_mv Rudin, C M
Cervantes, A
Dowlati, A
Besse, B
Ma, B
Costa, D B
Schmid, P
Heist, R
Villaflor, V M
Spahn, J
Li, S
Cha, E
Riely, G J
Gettinger, S
author Rudin, C M
author_facet Rudin, C M
Cervantes, A
Dowlati, A
Besse, B
Ma, B
Costa, D B
Schmid, P
Heist, R
Villaflor, V M
Spahn, J
Li, S
Cha, E
Riely, G J
Gettinger, S
author_role author
author2 Cervantes, A
Dowlati, A
Besse, B
Ma, B
Costa, D B
Schmid, P
Heist, R
Villaflor, V M
Spahn, J
Li, S
Cha, E
Riely, G J
Gettinger, S
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv EGFR-mutant NSCLC
PD-L1 inhibitor
immune checkpoint inhibitor
tyrosine kinase inhibitor
topic EGFR-mutant NSCLC
PD-L1 inhibitor
immune checkpoint inhibitor
tyrosine kinase inhibitor
description BACKGROUND: Acquired resistance limits long-term epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) efficacy in patients with EGFR mutation-positive non-small-cell lung cancer (NSCLC) in whom anti-programmed death-ligand 1 (PD-L1) efficacy is also limited. We hypothesized that combining atezolizumab with erlotinib could enhance antitumor immunity and extend efficacy in these patients.; PATIENTS AND METHODS: This open-label phase Ib trial was conducted in adults aged =18 years who had advanced, unresectable NSCLC. Stage 1 (safety evaluation) enrolled EGFR TKI-naive patients regardless of EGFR status. Stage 2 (expansion) enrolled patients with EGFR-mutant NSCLC treated with =1 prior non-EGFR TKI therapy. Patients received 150 mg erlotinib orally once daily. After a 7-day erlotinib run-in, atezolizumab 1200 mg was administered intravenously every 3 weeks. The primary endpoint was the safety and tolerability of the combination in all patients; secondary endpoints included antitumor activity per RECIST 1.1 in stage 2 patients.; RESULTS: At the data cut-off on 7 May 2020, 28 patients (8 in stage 1, 20 in stage 2) were assessable for safety. No dose-limiting toxicities or grade 4 or 5 treatment-related adverse events occurred. Grade 3 treatment-related adverse events occurred in 46% of patients; the most common were increased alanine aminotransferase, diarrhea, pyrexia, and rash (each in 7% of patients). Serious adverse events occurred in 50% of patients. Pneumonitis (grade 1) was reported in a single patient (4%). The objective response rate was 75% [95% confidence interval (CI) 50.9% to 91.3%]), median response duration was 18.9 months (95% CI 9.5-40.5 months), median progression-free survival was 15.4 months (95% CI 8.4-39.0 months), and median overall survival was not estimable (NE) (95% CI 34.6-NE).; CONCLUSIONS: Atezolizumab combined with erlotinib demonstrated a tolerable safety profile and encouraging, durable clinical activity in patients with advanced EGFR mutation-positive NSCLC. Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.
publishDate 2023
dc.date.none.fl_str_mv 2023
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://incliva.portalinvestigacion.com/publicaciones/17343
url https://incliva.portalinvestigacion.com/publicaciones/17343
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv ELSEVIER
publisher.none.fl_str_mv ELSEVIER
dc.source.none.fl_str_mv ESMO Open
ISSN: 20597029
reponame:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
instname:INCLIVA
instname_str INCLIVA
reponame_str r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
collection r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
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