The ESMO Tumour-Agnostic Classifier and Screener (ETAC-S): a tool for assessing tumour-agnostic potential of molecularly guided therapies and for steering drug development

Drug development; Molecular targeted therapy; Tumour-agnostic

Detalles Bibliográficos
Autores: Martins-Branco, Diogo, Rodrigues Beal, Juliana, Coleman, Niamh, Westphalen, Benedikt, Cardone, Claudia, Schram, Alison, GARRALDA, Elena, Mateo, Joaquin
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2024
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:11351/12238
Acceso en línea:https://hdl.handle.net/11351/12238
http://hdl.handle.net/11351/12238
Access Level:acceso abierto
Palabra clave:Medicina personalitzada
Càncer - Tractament
Medicaments - Desenvolupament
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Precision Medicine
DISEASES::Neoplasms
Other subheadings::Other subheadings::Other subheadings::/drug therapy
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Drug Therapy::Molecular Targeted Therapy
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Investigative Techniques::Drug Development
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::medicina de precisión
ENFERMEDADES::neoplasias
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::farmacoterapia::terapia molecular selectiva
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::técnicas de investigación::desarrollo de medicamentos
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oai_identifier_str oai:recercat.cat:11351/12238
network_acronym_str ES
network_name_str España
repository_id_str
dc.title.none.fl_str_mv The ESMO Tumour-Agnostic Classifier and Screener (ETAC-S): a tool for assessing tumour-agnostic potential of molecularly guided therapies and for steering drug development
title The ESMO Tumour-Agnostic Classifier and Screener (ETAC-S): a tool for assessing tumour-agnostic potential of molecularly guided therapies and for steering drug development
spellingShingle The ESMO Tumour-Agnostic Classifier and Screener (ETAC-S): a tool for assessing tumour-agnostic potential of molecularly guided therapies and for steering drug development
Martins-Branco, Diogo
Medicina personalitzada
Càncer - Tractament
Medicaments - Desenvolupament
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Precision Medicine
DISEASES::Neoplasms
Other subheadings::Other subheadings::Other subheadings::/drug therapy
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Drug Therapy::Molecular Targeted Therapy
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Investigative Techniques::Drug Development
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::medicina de precisión
ENFERMEDADES::neoplasias
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::farmacoterapia::terapia molecular selectiva
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::técnicas de investigación::desarrollo de medicamentos
title_short The ESMO Tumour-Agnostic Classifier and Screener (ETAC-S): a tool for assessing tumour-agnostic potential of molecularly guided therapies and for steering drug development
title_full The ESMO Tumour-Agnostic Classifier and Screener (ETAC-S): a tool for assessing tumour-agnostic potential of molecularly guided therapies and for steering drug development
title_fullStr The ESMO Tumour-Agnostic Classifier and Screener (ETAC-S): a tool for assessing tumour-agnostic potential of molecularly guided therapies and for steering drug development
title_full_unstemmed The ESMO Tumour-Agnostic Classifier and Screener (ETAC-S): a tool for assessing tumour-agnostic potential of molecularly guided therapies and for steering drug development
title_sort The ESMO Tumour-Agnostic Classifier and Screener (ETAC-S): a tool for assessing tumour-agnostic potential of molecularly guided therapies and for steering drug development
dc.creator.none.fl_str_mv Martins-Branco, Diogo
Rodrigues Beal, Juliana
Coleman, Niamh
Westphalen, Benedikt
Cardone, Claudia
Schram, Alison
GARRALDA, Elena
Mateo, Joaquin
author Martins-Branco, Diogo
author_facet Martins-Branco, Diogo
Rodrigues Beal, Juliana
Coleman, Niamh
Westphalen, Benedikt
Cardone, Claudia
Schram, Alison
GARRALDA, Elena
Mateo, Joaquin
author_role author
author2 Rodrigues Beal, Juliana
Coleman, Niamh
Westphalen, Benedikt
Cardone, Claudia
Schram, Alison
GARRALDA, Elena
Mateo, Joaquin
author2_role author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Institut Català de la Salut
[Westphalen CB] Comprehensive Cancer Center Munich & Department of Medicine III, University Hospital, LMU Munich, Munich. German Cancer Consortium (DKTK), partner site Munich, German Cancer Research Center (DKFZ), Heidelberg, Germany. [Martins-Branco D] Scientific and Medical Division, European Society for Medical Oncology (ESMO), Lugano, Switzerland. [Beal JR] Hospital Israelita Albert Einstein, Sao Paulo, Brazil. [Cardone C] Experimental Clinical Abdominal Oncology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Naples, Italy. [Coleman N] School of Medicine, Trinity College Dublin, Dublin. Medical Oncology Department, St. James’s Hospital, Dublin. Trinity St. James’s Cancer Institute, Dublin, Ireland. [Schram AM] Department of Medicine, Memorial Sloan Kettering Cancer Center, New York City. Weill Cornell Medical College, New York City. [Garralda E, Mateo J] Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain
Vall d'Hebron Barcelona Hospital Campus
dc.subject.none.fl_str_mv Medicina personalitzada
Càncer - Tractament
Medicaments - Desenvolupament
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Precision Medicine
DISEASES::Neoplasms
Other subheadings::Other subheadings::Other subheadings::/drug therapy
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Drug Therapy::Molecular Targeted Therapy
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Investigative Techniques::Drug Development
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::medicina de precisión
ENFERMEDADES::neoplasias
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::farmacoterapia::terapia molecular selectiva
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::técnicas de investigación::desarrollo de medicamentos
topic Medicina personalitzada
Càncer - Tractament
Medicaments - Desenvolupament
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Precision Medicine
DISEASES::Neoplasms
Other subheadings::Other subheadings::Other subheadings::/drug therapy
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Drug Therapy::Molecular Targeted Therapy
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Investigative Techniques::Drug Development
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::medicina de precisión
ENFERMEDADES::neoplasias
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::farmacoterapia::terapia molecular selectiva
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::técnicas de investigación::desarrollo de medicamentos
description Drug development; Molecular targeted therapy; Tumour-agnostic
publishDate 2024
dc.date.none.fl_str_mv 2024
2024
2024
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/11351/12238
http://hdl.handle.net/11351/12238
url https://hdl.handle.net/11351/12238
http://hdl.handle.net/11351/12238
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Annals of Oncology;35(11)
https://doi.org/10.1016/j.annonc.2024.07.730
dc.rights.none.fl_str_mv Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Attribution 4.0 International
http://creativecommons.org/licenses/by/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_ 1869422803634094080
spelling The ESMO Tumour-Agnostic Classifier and Screener (ETAC-S): a tool for assessing tumour-agnostic potential of molecularly guided therapies and for steering drug developmentMartins-Branco, DiogoRodrigues Beal, JulianaColeman, NiamhWestphalen, BenediktCardone, ClaudiaSchram, AlisonGARRALDA, ElenaMateo, JoaquinMedicina personalitzadaCàncer - TractamentMedicaments - DesenvolupamentANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Precision MedicineDISEASES::NeoplasmsOther subheadings::Other subheadings::Other subheadings::/drug therapyANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Drug Therapy::Molecular Targeted TherapyANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Investigative Techniques::Drug DevelopmentTÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::medicina de precisiónENFERMEDADES::neoplasiasOtros calificadores::Otros calificadores::Otros calificadores::/farmacoterapiaTÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::farmacoterapia::terapia molecular selectivaTÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::técnicas de investigación::desarrollo de medicamentosDrug development; Molecular targeted therapy; Tumour-agnosticDesarrollo de fármacos; Terapia molecular dirigida; Tumor agnósticoDesenvolupament de medicaments; Teràpia molecular dirigida; Tumor agnòsticBackground Advances in precision oncology led to approval of tumour-agnostic molecularly guided treatment options (MGTOs). The minimum requirements for claiming tumour-agnostic potential remain elusive. Methods The European Society for Medical Oncology (ESMO) Precision Medicine Working Group (PMWG) coordinated a project to optimise tumour-agnostic drug development. International experts examined and summarised the publicly available data used for regulatory assessment of the tumour-agnostic indications approved by the US Food and Drug Administration and/or the European Medicines Agency as of December 2023. Different scenarios of minimum objective response rate (ORR), number of tumour types investigated, and number of evaluable patients per tumour type were assessed for developing a screening tool for tumour-agnostic potential. This tool was tested using the tumour-agnostic indications approved during the first half of 2024. A taxonomy for MGTOs and a framework for tumour-agnostic drug development were conceptualised. Results Each tumour-agnostic indication had data establishing objective response in at least one out of five patients (ORR ≥ 20%) in two-thirds (≥4) of the investigated tumour types, with at least five evaluable patients in each tumour type. These minimum requirements were met by tested indications and may serve as a screening tool for tumour-agnostic potential, requiring further validation. We propose a conceptual taxonomy classifying MGTOs based on the therapeutic effect obtained by targeting a driver molecular aberration across tumours and its modulation by tumour-specific biology: tumour-agnostic, tumour-modulated, or tumour-restricted. The presence of biology-informed mechanistic rationale, early regulatory advice, and adequate trial design demonstrating signs of biology-driven tumour-agnostic activity, followed by confirmatory evidence, should be the principles for tumour-agnostic drug development. Conclusion The ESMO Tumour-Agnostic Classifier (ETAC) focuses on the interplay of targeted driver molecular aberration and tumour-specific biology modulating the therapeutic effect of MGTOs. We propose minimum requirements to screen for tumour-agnostic potential (ETAC-S) as part of tumour-agnostic drug development. Definition of ETAC cut-offs is warranted.This project was funded by the European Society for Medical Oncology (no grant number applies).ElsevierInstitut Català de la Salut[Westphalen CB] Comprehensive Cancer Center Munich & Department of Medicine III, University Hospital, LMU Munich, Munich. German Cancer Consortium (DKTK), partner site Munich, German Cancer Research Center (DKFZ), Heidelberg, Germany. [Martins-Branco D] Scientific and Medical Division, European Society for Medical Oncology (ESMO), Lugano, Switzerland. [Beal JR] Hospital Israelita Albert Einstein, Sao Paulo, Brazil. [Cardone C] Experimental Clinical Abdominal Oncology Unit, Istituto Nazionale Tumori- IRCCS-Fondazione G. Pascale, Naples, Italy. [Coleman N] School of Medicine, Trinity College Dublin, Dublin. Medical Oncology Department, St. James’s Hospital, Dublin. Trinity St. James’s Cancer Institute, Dublin, Ireland. [Schram AM] Department of Medicine, Memorial Sloan Kettering Cancer Center, New York City. Weill Cornell Medical College, New York City. [Garralda E, Mateo J] Vall d’Hebron Institute of Oncology (VHIO), Barcelona, SpainVall d'Hebron Barcelona Hospital Campus202420242024info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/11351/12238http://hdl.handle.net/11351/12238Scientiareponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésAnnals of Oncology;35(11)https://doi.org/10.1016/j.annonc.2024.07.730Attribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:11351/122382026-05-29T05:05:01Z
score 15,811543

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