Phase II multicohort study of atezolizumab monotherapy in multiple advanced solid cancers

PD-L1 checkpoint inhibitor; Atezolizumab; Solid tumors

Detalles Bibliográficos
Autores: Tabernero Caturla, Josep, André, Fabrice, Bustillos, A., Fear, S., Ganta, S., Blay, Jean-Yves
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:11351/7976
Acceso en línea:https://hdl.handle.net/11351/7976
http://hdl.handle.net/11351/7976
Access Level:acceso abierto
Palabra clave:Càncer - Tractament
Anticossos monoclonals
DISEASES::Neoplasms
Other subheadings::Other subheadings::Other subheadings::/drug therapy
CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal::Antibodies, Monoclonal, Humanized
ENFERMEDADES::neoplasias
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales::anticuerpos monoclonales humanizados
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oai_identifier_str oai:recercat.cat:11351/7976
network_acronym_str ES
network_name_str España
repository_id_str
dc.title.none.fl_str_mv Phase II multicohort study of atezolizumab monotherapy in multiple advanced solid cancers
title Phase II multicohort study of atezolizumab monotherapy in multiple advanced solid cancers
spellingShingle Phase II multicohort study of atezolizumab monotherapy in multiple advanced solid cancers
Tabernero Caturla, Josep
Càncer - Tractament
Anticossos monoclonals
DISEASES::Neoplasms
Other subheadings::Other subheadings::Other subheadings::/drug therapy
CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal::Antibodies, Monoclonal, Humanized
ENFERMEDADES::neoplasias
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales::anticuerpos monoclonales humanizados
title_short Phase II multicohort study of atezolizumab monotherapy in multiple advanced solid cancers
title_full Phase II multicohort study of atezolizumab monotherapy in multiple advanced solid cancers
title_fullStr Phase II multicohort study of atezolizumab monotherapy in multiple advanced solid cancers
title_full_unstemmed Phase II multicohort study of atezolizumab monotherapy in multiple advanced solid cancers
title_sort Phase II multicohort study of atezolizumab monotherapy in multiple advanced solid cancers
dc.creator.none.fl_str_mv Tabernero Caturla, Josep
André, Fabrice
Bustillos, A.
Fear, S.
Ganta, S.
Blay, Jean-Yves
author Tabernero Caturla, Josep
author_facet Tabernero Caturla, Josep
André, Fabrice
Bustillos, A.
Fear, S.
Ganta, S.
Blay, Jean-Yves
author_role author
author2 André, Fabrice
Bustillos, A.
Fear, S.
Ganta, S.
Blay, Jean-Yves
author2_role author
author
author
author
author
dc.contributor.none.fl_str_mv Institut Català de la Salut
[Tabernero J] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. UVic-UCC, IOB-Quiron, Barcelona, Spain. [Andre F] Gustave Roussy Cancer Campus Grand Paris, Villejuif, France. [Blay JY] Centre Léon Bérard, Lyon, France. [Bustillos A, Fear S] Global Product Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland. [Ganta S] Product Development Safety, F. Hoffmann-La Roche Ltd, Basel, Switzerland
Vall d'Hebron Barcelona Hospital Campus
dc.subject.none.fl_str_mv Càncer - Tractament
Anticossos monoclonals
DISEASES::Neoplasms
Other subheadings::Other subheadings::Other subheadings::/drug therapy
CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal::Antibodies, Monoclonal, Humanized
ENFERMEDADES::neoplasias
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales::anticuerpos monoclonales humanizados
topic Càncer - Tractament
Anticossos monoclonals
DISEASES::Neoplasms
Other subheadings::Other subheadings::Other subheadings::/drug therapy
CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal::Antibodies, Monoclonal, Humanized
ENFERMEDADES::neoplasias
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales::anticuerpos monoclonales humanizados
description PD-L1 checkpoint inhibitor; Atezolizumab; Solid tumors
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/11351/7976
http://hdl.handle.net/11351/7976
url https://hdl.handle.net/11351/7976
http://hdl.handle.net/11351/7976
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv ESMO Open;7(2)
https://doi.org/10.1016/j.esmoop.2022.100419
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_ 1869403550924144640
spelling Phase II multicohort study of atezolizumab monotherapy in multiple advanced solid cancersTabernero Caturla, JosepAndré, FabriceBustillos, A.Fear, S.Ganta, S.Blay, Jean-YvesCàncer - TractamentAnticossos monoclonalsDISEASES::NeoplasmsOther subheadings::Other subheadings::Other subheadings::/drug therapyCHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal::Antibodies, Monoclonal, HumanizedENFERMEDADES::neoplasiasOtros calificadores::Otros calificadores::Otros calificadores::/farmacoterapiaCOMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales::anticuerpos monoclonales humanizadosPD-L1 checkpoint inhibitor; Atezolizumab; Solid tumorsInhibidor del punto de control PD-L1; Atezolizumab; Tumores sólidosInhibidor del punt de control PD-L1; Atezolizumab; Tumors sòlidsBackground The programmed death-ligand 1 inhibitor atezolizumab had shown clinical activity against several advanced malignancies. Patients and methods This phase II, open-label basket study (NCT02458638) was conducted in 16 main cohorts of patients aged ≥18 years with stage III or IV solid tumors. In stage I, 12 patients were enrolled into each cohort. Treatment was atezolizumab 1200 mg intravenously every 3 weeks until loss of clinical benefit or unacceptable toxicity. The primary efficacy endpoint was the non-progression rate (NPR) at 18 weeks in treated, assessable patients. NPR ≤20% was not of interest for development as monotherapy, and NPR ≥40% was defined as the threshold of benefit/success. If ≥3 patients had non-progressive disease in stage I (interim analysis), 13 additional patients could be enrolled into stage II (final analysis). Secondary efficacy and safety endpoints were also evaluated. Results Overall, 474 patients were enrolled and treated; 433 were included in the efficacy set. Due partly to slow recruitment because of competing trials and limited efficacy at interim analyses, enrollment was stopped early, including in cohorts that passed stage I boundaries of success. NPR was >20% in five cohorts: cervical cancer {n = 27; NPR 44.4% [95% confidence interval (CI) 25.5% to 64.7%]}; follicular/papillary thyroid cancer [n = 11; 54.5% (95% CI 23.4% to 83.3%)]; thymoma [n = 13; 76.9% (95% CI: 46.2% to 95.0%)]; gastroenteropancreatic (GEP) and lung neuroendocrine tumors [NETs; n = 24; 41.7% (95% CI 22.1% to 63.4%)], and low/intermediate grade carcinoid GEP and lung NETs [n = 12; 58.3% (95% CI 27.7% to 84.8%)]. Treatment-related adverse events occurred in 55.3% of patients overall, and at grade 3, 4, and 5 in 10.3%, 1.7%, and 0.4%, respectively. Conclusions Atezolizumab monotherapy was effective in the cervical cancer cohort. The interim benefit threshold was crossed in patients with follicular/papillary thyroid cancer, thymoma, and GEP and lung NETs, but recruitment was stopped before these signals could be confirmed in stage II. Safety was consistent with previous findings.This study was supported by F. Hoffmann-La Roche (no grant number) who provided financial support for the conduct of study and were involved in study design; in the collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the article for publication. They also funded assistance with manuscript writing by a professional medical writer.ElsevierInstitut Català de la Salut[Tabernero J] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. UVic-UCC, IOB-Quiron, Barcelona, Spain. [Andre F] Gustave Roussy Cancer Campus Grand Paris, Villejuif, France. [Blay JY] Centre Léon Bérard, Lyon, France. [Bustillos A, Fear S] Global Product Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland. [Ganta S] Product Development Safety, F. Hoffmann-La Roche Ltd, Basel, SwitzerlandVall d'Hebron Barcelona Hospital Campus202220222022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/11351/7976http://hdl.handle.net/11351/7976Scientiareponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésESMO Open;7(2)https://doi.org/10.1016/j.esmoop.2022.100419Attribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:11351/79762026-05-29T05:05:01Z
score 15,812429

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