Optimizing early-phase immunotherapy trials: the role of biomarker enrichment strategies

Other authors

Institut Català de la Salut

[Catani G] Department of Medical Oncology, Alexander Fleming Institute, Buenos Aires, Argentina. Vall d'Hebron Institut d'Oncologia (VHIO), Barcelona, Spain. [Morchón-Araujo D] Vall d'Hebron Institut d'Oncologia (VHIO), Barcelona, Spain. Department of Medical Oncology, University Hospital of Salamanca, IBSAL, Salamanca, Spain. [Mirallas O] Vall d'Hebron Institut d'Oncologia (VHIO), Barcelona, Spain. Servei d’Oncologia Mèdica, Hospital Universitari Vall d’Hebron, Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain. [Sánchez-Pérez V, Garralda E, Hernando-Calvo A] Vall d'Hebron Institut d'Oncologia (VHIO), Barcelona, Spain. Servei d’Oncologia Mèdica, Hospital Universitari Vall d’Hebron, Barcelona, Spain. [Nuciforo P] Vall d'Hebron Institut d'Oncologia (VHIO), Barcelona, Spain. Grup d’Oncologia Molecular, Vall d'Hebron Institut d'Oncologia (VHIO), Barcelona, Spain. [Villacampa G, Vivancos A] Vall d'Hebron Institut d'Oncologia (VHIO), Barcelona, Spain. [Dienstmann R] Ciència de Dades en Oncologia, Vall d'Hebron Institut d'Oncologia (VHIO), Barcelona, Spain. Universitat de Vic, Universitat Central de Catalunya, Vic, Spain. Oncoclinicas Medicina de Precisão, Oncoclínicas & Co, São Paulo, Brazil.

Vall d'Hebron Barcelona Hospital Campus

Publication date

2026-04-17T07:41:00Z

2026-04-17T07:41:00Z

2025-10-22



Abstract

Biomarker; Drug response biomarkers; Early-phase trials


Biomarcador; Biomarcadors de resposta a fàrmacs; Assaigs de fase inicial


Biomarcador; Biomarcadores de respuesta a fármacos; Ensayos de fase inicial


Immune checkpoint inhibitors have revolutionized the treatment of solid tumors; however, their clinical efficacy remains limited to a subset of patients. Novel immunotherapy agents are being investigated in phase I clinical trials, with an increasing focus on biomarker selection strategies to optimize patient outcomes. Prior evidence suggests that biomarker-selected tumors may have better outcomes when treated with molecularly-guided therapies. However, the high complexity of tumor-host interactions and inter-patient variability indicates that a one-size-fits-all biomarker approach is unlikely to be sufficient in the immunotherapy landscape. This review highlights current biomarker-enrichment strategies in immunotherapy early drug development, addressing challenges and potential future directions for their effective implementation.


The author(s) declare financial support was received for the research and/or publication of this article. This research and the APC were funded by the Comprehensive Program of Cancer Immunotherapy & Immunology II (CAIMI-II) and supported by the BBVA Foundation (grant 53/2021). This research has been funded by the CaixaResearch Advanced Oncology Research Program supported by “la Caixa” Foundation (LCF/PR/CE07/50610001).

Document Type

Article


Published version

Language

English

Publisher

Frontiers Media

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Frontiers in Immunology;16

https://doi.org/10.3389/fimmu.2025.1664443

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Rights

Attribution 4.0 International

http://creativecommons.org/licenses/by/4.0/

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