The need for a network to establish and validate predictive biomarkers in cancer immunotherapy

Giuseppe V. Masucci, Alessandra Cesano, Alexander Eggermont, Bernard A. Fox, Ena Wang, Francesco M. Marincola, Gennaro Ciliberto, Kevin Dobbin, Igor Puzanov, Janis Taube, Jennifer Wargo, Lisa H. Butterfield, Lisa Villabona, Magdalena Thurin, Michael A. Postow, Paul M. Sondel, Sandra Demaria, Sanjiv Agarwala, Paolo A. Ascierto

Research output: Contribution to journalComment/debate

10 Citations (Scopus)

Abstract

Immunotherapies have emerged as one of the most promising approaches to treat patients with cancer. Recently, the entire medical oncology field has been revolutionized by the introduction of immune checkpoints inhibitors. Despite success in a variety of malignancies, responses typically only occur in a small percentage of patients for any given histology or treatment regimen. There are also concerns that immunotherapies are associated with immune-related toxicity as well as high costs. As such, identifying biomarkers to determine which patients are likely to derive clinical benefit from which immunotherapy and/or be susceptible to adverse side effects is a compelling clinical and social need. In addition, with several new immunotherapy agents in different phases of development, and approved therapeutics being tested in combination with a variety of different standard of care treatments, there is a requirement to stratify patients and select the most appropriate population in which to assess clinical efficacy. The opportunity to design parallel biomarkers studies that are integrated within key randomized clinical trials could be the ideal solution. Sample collection (fresh and/or archival tissue, PBMC, serum, plasma, stool, etc.) at specific points of treatment is important for evaluating possible biomarkers and studying the mechanisms of responsiveness, resistance, toxicity and relapse. This white paper proposes the creation of a network to facilitate the sharing and coordinating of samples from clinical trials to enable more in-depth analyses of correlative biomarkers than is currently possible and to assess the feasibilities, logistics, and collated interests. We propose a high standard of sample collection and storage as well as exchange of samples and knowledge through collaboration, and envisage how this could move forward using banked samples from completed studies together with prospective planning for ongoing and future clinical trials.

Original languageEnglish
Article number223
JournalJournal of Translational Medicine
Volume15
Issue number1
DOIs
Publication statusPublished - Nov 3 2017

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Biomarkers
Tumor Biomarkers
Immunotherapy
Toxicity
Clinical Trials
Histology
Oncology
Medical Oncology
Therapeutics
Standard of Care
Logistics
Neoplasms
Randomized Controlled Trials
Tissue
Plasmas
Costs and Cost Analysis
Planning
Recurrence
Serum
Population

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)

Cite this

The need for a network to establish and validate predictive biomarkers in cancer immunotherapy. / Masucci, Giuseppe V.; Cesano, Alessandra; Eggermont, Alexander; Fox, Bernard A.; Wang, Ena; Marincola, Francesco M.; Ciliberto, Gennaro; Dobbin, Kevin; Puzanov, Igor; Taube, Janis; Wargo, Jennifer; Butterfield, Lisa H.; Villabona, Lisa; Thurin, Magdalena; Postow, Michael A.; Sondel, Paul M.; Demaria, Sandra; Agarwala, Sanjiv; Ascierto, Paolo A.

In: Journal of Translational Medicine, Vol. 15, No. 1, 223, 03.11.2017.

Research output: Contribution to journalComment/debate

Masucci, GV, Cesano, A, Eggermont, A, Fox, BA, Wang, E, Marincola, FM, Ciliberto, G, Dobbin, K, Puzanov, I, Taube, J, Wargo, J, Butterfield, LH, Villabona, L, Thurin, M, Postow, MA, Sondel, PM, Demaria, S, Agarwala, S & Ascierto, PA 2017, 'The need for a network to establish and validate predictive biomarkers in cancer immunotherapy', Journal of Translational Medicine, vol. 15, no. 1, 223. https://doi.org/10.1186/s12967-017-1325-2
Masucci, Giuseppe V. ; Cesano, Alessandra ; Eggermont, Alexander ; Fox, Bernard A. ; Wang, Ena ; Marincola, Francesco M. ; Ciliberto, Gennaro ; Dobbin, Kevin ; Puzanov, Igor ; Taube, Janis ; Wargo, Jennifer ; Butterfield, Lisa H. ; Villabona, Lisa ; Thurin, Magdalena ; Postow, Michael A. ; Sondel, Paul M. ; Demaria, Sandra ; Agarwala, Sanjiv ; Ascierto, Paolo A. / The need for a network to establish and validate predictive biomarkers in cancer immunotherapy. In: Journal of Translational Medicine. 2017 ; Vol. 15, No. 1.
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abstract = "Immunotherapies have emerged as one of the most promising approaches to treat patients with cancer. Recently, the entire medical oncology field has been revolutionized by the introduction of immune checkpoints inhibitors. Despite success in a variety of malignancies, responses typically only occur in a small percentage of patients for any given histology or treatment regimen. There are also concerns that immunotherapies are associated with immune-related toxicity as well as high costs. As such, identifying biomarkers to determine which patients are likely to derive clinical benefit from which immunotherapy and/or be susceptible to adverse side effects is a compelling clinical and social need. In addition, with several new immunotherapy agents in different phases of development, and approved therapeutics being tested in combination with a variety of different standard of care treatments, there is a requirement to stratify patients and select the most appropriate population in which to assess clinical efficacy. The opportunity to design parallel biomarkers studies that are integrated within key randomized clinical trials could be the ideal solution. Sample collection (fresh and/or archival tissue, PBMC, serum, plasma, stool, etc.) at specific points of treatment is important for evaluating possible biomarkers and studying the mechanisms of responsiveness, resistance, toxicity and relapse. This white paper proposes the creation of a network to facilitate the sharing and coordinating of samples from clinical trials to enable more in-depth analyses of correlative biomarkers than is currently possible and to assess the feasibilities, logistics, and collated interests. We propose a high standard of sample collection and storage as well as exchange of samples and knowledge through collaboration, and envisage how this could move forward using banked samples from completed studies together with prospective planning for ongoing and future clinical trials.",
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AU - Wargo, Jennifer

AU - Butterfield, Lisa H.

AU - Villabona, Lisa

AU - Thurin, Magdalena

AU - Postow, Michael A.

AU - Sondel, Paul M.

AU - Demaria, Sandra

AU - Agarwala, Sanjiv

AU - Ascierto, Paolo A.

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