Safety and preliminary activity results of the GATTO study, a phase Ib study combining the anti-TA-MUC1 antibody gatipotuzumab with the anti-EGFR tomuzotuximab in patients with refractory solid tumors

Colorectal cancer; Lung cancer; Monoclonal antibody

Detalhes bibliográficos
Autores: Fiedler, W. M., Conte, G. D., Macchini, Marina, Matos Garcia, Ignacio, Habel, B., Saavedra Gadea, Omar, Garralda Cabanas, Elena, Ochsenreither, Sebastian
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2022
País:España
Recursos: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:11351/8373
Acesso em linha:https://hdl.handle.net/11351/8373
Access Level:acceso abierto
Palavra-chave:Càncer - Tractament
Anticossos monoclonals - Efectes secundaris
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
Other subheadings::Other subheadings::Other subheadings::/adverse effects
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
Otros calificadores::Otros calificadores::Otros calificadores::/efectos adversos
id ES_4b2adbe5311bd2b208efea5149f11c4a
oai_identifier_str oai:recercat.cat:11351/8373
network_acronym_str ES
network_name_str España
repository_id_str
dc.title.none.fl_str_mv Safety and preliminary activity results of the GATTO study, a phase Ib study combining the anti-TA-MUC1 antibody gatipotuzumab with the anti-EGFR tomuzotuximab in patients with refractory solid tumors
title Safety and preliminary activity results of the GATTO study, a phase Ib study combining the anti-TA-MUC1 antibody gatipotuzumab with the anti-EGFR tomuzotuximab in patients with refractory solid tumors
spellingShingle Safety and preliminary activity results of the GATTO study, a phase Ib study combining the anti-TA-MUC1 antibody gatipotuzumab with the anti-EGFR tomuzotuximab in patients with refractory solid tumors
Fiedler, W. M.
Càncer - Tractament
Anticossos monoclonals - Efectes secundaris
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
Other subheadings::Other subheadings::Other subheadings::/adverse effects
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
Otros calificadores::Otros calificadores::Otros calificadores::/efectos adversos
title_short Safety and preliminary activity results of the GATTO study, a phase Ib study combining the anti-TA-MUC1 antibody gatipotuzumab with the anti-EGFR tomuzotuximab in patients with refractory solid tumors
title_full Safety and preliminary activity results of the GATTO study, a phase Ib study combining the anti-TA-MUC1 antibody gatipotuzumab with the anti-EGFR tomuzotuximab in patients with refractory solid tumors
title_fullStr Safety and preliminary activity results of the GATTO study, a phase Ib study combining the anti-TA-MUC1 antibody gatipotuzumab with the anti-EGFR tomuzotuximab in patients with refractory solid tumors
title_full_unstemmed Safety and preliminary activity results of the GATTO study, a phase Ib study combining the anti-TA-MUC1 antibody gatipotuzumab with the anti-EGFR tomuzotuximab in patients with refractory solid tumors
title_sort Safety and preliminary activity results of the GATTO study, a phase Ib study combining the anti-TA-MUC1 antibody gatipotuzumab with the anti-EGFR tomuzotuximab in patients with refractory solid tumors
dc.creator.none.fl_str_mv Fiedler, W. M.
Conte, G. D.
Macchini, Marina
Matos Garcia, Ignacio
Habel, B.
Saavedra Gadea, Omar
Garralda Cabanas, Elena
Ochsenreither, Sebastian
author Fiedler, W. M.
author_facet Fiedler, W. M.
Conte, G. D.
Macchini, Marina
Matos Garcia, Ignacio
Habel, B.
Saavedra Gadea, Omar
Garralda Cabanas, Elena
Ochsenreither, Sebastian
author_role author
author2 Conte, G. D.
Macchini, Marina
Matos Garcia, Ignacio
Habel, B.
Saavedra Gadea, Omar
Garralda Cabanas, Elena
Ochsenreither, Sebastian
author2_role author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Institut Català de la Salut
[Ochsenreither S] Charité Comprehensive Cancer Center, Berlin, Germany. Charité, Department of Hematology, Oncology and Tumor Immunology, Berlin, Germany. German Cancer Consortium (DKTK), Berlin, Germany. [Fiedler WM] University Medical Center Hamburg-Eppendorf, Hubertus-Wald University Cancer Center, Hamburg, Germany. [Conte GD, Macchini M] Fondazione IRCCS San Raffaele Hospital, Milan, Italy. [Matos I, Saavedra O, Garralda E] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Habel B] Glycotope GmbH, Berlin, Germany
Vall d'Hebron Barcelona Hospital Campus
dc.subject.none.fl_str_mv Càncer - Tractament
Anticossos monoclonals - Efectes secundaris
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
Other subheadings::Other subheadings::Other subheadings::/adverse effects
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
Otros calificadores::Otros calificadores::Otros calificadores::/efectos adversos
topic Càncer - Tractament
Anticossos monoclonals - Efectes secundaris
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
Other subheadings::Other subheadings::Other subheadings::/adverse effects
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
Otros calificadores::Otros calificadores::Otros calificadores::/efectos adversos
description Colorectal cancer; Lung cancer; Monoclonal antibody
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/11351/8373
url https://hdl.handle.net/11351/8373
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.2022.100447
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_ 1869407542010970112
spelling Safety and preliminary activity results of the GATTO study, a phase Ib study combining the anti-TA-MUC1 antibody gatipotuzumab with the anti-EGFR tomuzotuximab in patients with refractory solid tumorsFiedler, W. M.Conte, G. D.Macchini, MarinaMatos Garcia, IgnacioHabel, B.Saavedra Gadea, OmarGarralda Cabanas, ElenaOchsenreither, SebastianCàncer - TractamentAnticossos monoclonals - Efectes secundarisDISEASES::NeoplasmsOther subheadings::Other subheadings::Other subheadings::/drug therapyCHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, MonoclonalOther subheadings::Other subheadings::Other subheadings::/adverse effectsENFERMEDADES::neoplasiasOtros calificadores::Otros calificadores::Otros calificadores::/farmacoterapiaCOMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonalesOtros calificadores::Otros calificadores::Otros calificadores::/efectos adversosColorectal cancer; Lung cancer; Monoclonal antibodyCáncer colorrectal; Cáncer de pulmón; Anticuerpo monoclonalCàncer colorectal; Càncer de pulmó; Anticòs monoclonalBackground The phase I GATTO study (NCT03360734) explored the feasibility, tolerability and preliminary activity of combining gatipotuzumab, a novel humanized monoclonal antibody binding to the tumor-associated epitope of mucin 1 (TA-MUC1) and an anti-epidermal growth factor receptor (anti-EGFR) antibody in refractory solid tumors. Patients and methods Initially the study enrolled primary phase (PP) patients with EGFR-positive metastatic solid tumors, for whom no standard treatment was available. Patients received gatipotuzumab administered at 1400 mg every 2 weeks, 6 weeks after the start of the glyco-optimized anti-EGFR antibody tomuzotuximab at 1200 mg every 2 weeks. As this regimen was proven safe, enrollment continued in an expansion phase (EP) of patients with refractory metastatic colorectal cancer, non-small-cell lung cancer, head and neck cancer and breast cancer. Tomuzotuximab and gatipotuzumab were given at the same doses and gatipotuzumab treatment started 1 week after the first dose of the anti-EGFR antibody. Additionally, investigators could use a commercial anti-EGFR antibody in place of tomuzotuximab. Results A total of 52 patients were enrolled, 20 in the PP and 32 in the EP. The combined treatment was well tolerated and no dose-limiting toxicity was observed in the whole study, nor related serious adverse event or death. Preliminary activity of the combination was observed, with one and four RECIST partial responses in the PP and EP, all in colorectal cancer patients. The trial was accompanied by a comprehensive translational research program for identification of biomarkers, including soluble TA-MUC1 (sTA-MUC1) in serum. In the EP, patients with baseline sTA-MUC1 levels above the median appeared to have improved progression-free survival and overall survival. Conclusions Combination of a TA-MUC1-targeting antibody and an EGFR-targeting antibody is safe and feasible. Interesting antitumor activity was observed in heavily pretreated patients. Future studies should test this combination together with chemotherapy and explore the potential of sTA-MUC1 as a companion biomarker for further development of the combination.This work was supported by Glycotope GmbH (no grant number).ElsevierInstitut Català de la Salut[Ochsenreither S] Charité Comprehensive Cancer Center, Berlin, Germany. Charité, Department of Hematology, Oncology and Tumor Immunology, Berlin, Germany. German Cancer Consortium (DKTK), Berlin, Germany. [Fiedler WM] University Medical Center Hamburg-Eppendorf, Hubertus-Wald University Cancer Center, Hamburg, Germany. [Conte GD, Macchini M] Fondazione IRCCS San Raffaele Hospital, Milan, Italy. [Matos I, Saavedra O, Garralda E] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Habel B] Glycotope GmbH, Berlin, GermanyVall d'Hebron Barcelona Hospital Campus202220222022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/11351/8373Scientiareponame: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.2022.100447Attribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:11351/83732026-05-29T05:05:01Z
score 15,811543

Registos relacionados