Society for Immunotherapy of Cancer (SITC) recommendations on intratumoral immunotherapy clinical trials (IICT): from premalignant to metastatic disease
Background Intratumorally delivered immunotherapies have the potential to favorably alter the local tumor microenvironment and may stimulate systemic host immunity, offering an alternative or adjunct to other local and systemic treatments. Despite their potential, these therapies have had limited su...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2024-04-01
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| Series: | Journal for ImmunoTherapy of Cancer |
| Online Access: | https://jitc.bmj.com/content/12/4/e008378.full |
| _version_ | 1797201210121388032 |
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| author | Bart Neyns Mark Middleton Aurélien Marabelle Ignacio Melero Ke Liu Nina Bhardwaj Tanja D de Gruijl Jason Chesney Robert Coffin Howard Kaufman Diwakar Davar Jason J Luke Georgina V Long Kevin J Harrington Sherene Loi Thierry de Baere David J Pinato Matthew Fury Ciara M Kelly Joshua D Brody Robert H Andtbacka Gregory Goldmacher Anuradha D Khilnani Rahul A Sheth Stephen B Solomon Philippe Szapary |
| author_facet | Bart Neyns Mark Middleton Aurélien Marabelle Ignacio Melero Ke Liu Nina Bhardwaj Tanja D de Gruijl Jason Chesney Robert Coffin Howard Kaufman Diwakar Davar Jason J Luke Georgina V Long Kevin J Harrington Sherene Loi Thierry de Baere David J Pinato Matthew Fury Ciara M Kelly Joshua D Brody Robert H Andtbacka Gregory Goldmacher Anuradha D Khilnani Rahul A Sheth Stephen B Solomon Philippe Szapary |
| author_sort | Bart Neyns |
| collection | DOAJ |
| description | Background Intratumorally delivered immunotherapies have the potential to favorably alter the local tumor microenvironment and may stimulate systemic host immunity, offering an alternative or adjunct to other local and systemic treatments. Despite their potential, these therapies have had limited success in late-phase trials for advanced cancer resulting in few formal approvals. The Society for Immunotherapy of Cancer (SITC) convened a panel of experts to determine how to design clinical trials with the greatest chance of demonstrating the benefits of intratumoral immunotherapy for patients with cancers across all stages of pathogenesis.Methods An Intratumoral Immunotherapy Clinical Trials Expert Panel composed of international key stakeholders from academia and industry was assembled. A multiple choice/free response survey was distributed to the panel, and the results of this survey were discussed during a half-day consensus meeting. Key discussion points are summarized in the following manuscript.Results The panel determined unique clinical trial designs tailored to different stages of cancer development—from premalignant to unresectable/metastatic—that can maximize the chance of capturing the effect of intratumoral immunotherapies. Design elements discussed included study type, patient stratification and exclusion criteria, indications of randomization, study arm determination, endpoints, biological sample collection, and response assessment with biomarkers and imaging. Populations to prioritize for the study of intratumoral immunotherapy, including stage, type of cancer and line of treatment, were also discussed along with common barriers to the development of these local treatments.Conclusions The SITC Intratumoral Immunotherapy Clinical Trials Expert Panel has identified key considerations for the design and implementation of studies that have the greatest potential to capture the effect of intratumorally delivered immunotherapies. With more effective and standardized trial designs, the potential of intratumoral immunotherapy can be realized and lead to regulatory approvals that will extend the benefit of these local treatments to the patients who need them the most. |
| first_indexed | 2024-04-24T07:43:55Z |
| format | Article |
| id | doaj.art-c46bb380ab4f4bb8bdb94dd95f2f7c6b |
| institution | Directory Open Access Journal |
| issn | 2051-1426 |
| language | English |
| last_indexed | 2024-04-24T07:43:55Z |
| publishDate | 2024-04-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | Journal for ImmunoTherapy of Cancer |
| spelling | doaj.art-c46bb380ab4f4bb8bdb94dd95f2f7c6b2024-04-19T07:55:09ZengBMJ Publishing GroupJournal for ImmunoTherapy of Cancer2051-14262024-04-0112410.1136/jitc-2023-008378Society for Immunotherapy of Cancer (SITC) recommendations on intratumoral immunotherapy clinical trials (IICT): from premalignant to metastatic diseaseBart Neyns0Mark Middleton1Aurélien Marabelle2Ignacio Melero3Ke Liu4Nina Bhardwaj5Tanja D de Gruijl6Jason Chesney7Robert Coffin8Howard Kaufman9Diwakar Davar10Jason J Luke11Georgina V Long12Kevin J Harrington13Sherene Loi14Thierry de Baere15David J Pinato16Matthew Fury17Ciara M Kelly18Joshua D Brody19Robert H Andtbacka20Gregory Goldmacher21Anuradha D Khilnani22Rahul A Sheth23Stephen B Solomon24Philippe Szapary25Department of Medical Oncology/Laboratory for Medical and Molecular Oncology (LMMO), Vrije Universiteit Brussel (VUB)/Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, BelgiumAff12 grid.451056.30000000121163923National Institute for Health Research Biomedical Research Centre London UKLaboratoire de Recherche Translationnelle en Immunothérapie (LRTI), INSERM U1015, Villejuif, FranceProgram of Immunology and Immunotherapy, Cima Universidad de Navarra, Pamplona, SpainMarengo Therapeutics, Inc, Cambridge, Massachusetts, USA3Department of Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, NY, USADepartment of Medical Oncology, Amsterdam UMC Locatie VUmc, Amsterdam, NetherlandsAff5 grid.266623.50000000121131622University of Louisville Louisville KY USAAff14 grid.417886.40000 0001 0657 5612Amgen Woburn MA USAAnkyra Therapeutics, Boston, Massachusetts, USA11UPMC Hillman Cancer Center, Pittsburgh, PA, USADepartment of Otolaryngology, University of Pittsburgh, Pittsburgh, Pennsylvania, USAMelanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, North Sydney, New South Wales, AustraliaDivision of Radiotherapy and Imaging, The Institute of Cancer Research, London, UKDivision of Research and Clinical Medicine, Peter MacCallum Cancer Centre, Melbourne, Victoria, AustraliaCenter for Biotherapies In Situ (BIOTHERIS), INSERM CIC1428, Interventional Radiology Unit, Department of Medical Imaging, Gustave Roussy Cancer Center, University of Paris Saclay, Villejuif, FranceSurgery and Cancer, Imperial College London, London, UK9Regeneron Pharmaceuticals, Inc., Basking Ridge, NJ, USADepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USAMarc and Jennifer Lipschultz Precision Immunology Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USAHiFiBiO Therapeutics, Cambridge, Massachusetts, USAMerck & Co Inc, Rahway, New Jersey, USAMerck & Co Inc, Rahway, New Jersey, USADepartment of Interventional Radiology, University of Texas MD Anderson Cancer Center, Houston, Texas, USAChief of Interventional Radiology, Memorial Sloan Kettering Cancer Center, New York, New York, USAInterventional Oncology, Johnson & Johnson, New Brunswick, New Jersey, USABackground Intratumorally delivered immunotherapies have the potential to favorably alter the local tumor microenvironment and may stimulate systemic host immunity, offering an alternative or adjunct to other local and systemic treatments. Despite their potential, these therapies have had limited success in late-phase trials for advanced cancer resulting in few formal approvals. The Society for Immunotherapy of Cancer (SITC) convened a panel of experts to determine how to design clinical trials with the greatest chance of demonstrating the benefits of intratumoral immunotherapy for patients with cancers across all stages of pathogenesis.Methods An Intratumoral Immunotherapy Clinical Trials Expert Panel composed of international key stakeholders from academia and industry was assembled. A multiple choice/free response survey was distributed to the panel, and the results of this survey were discussed during a half-day consensus meeting. Key discussion points are summarized in the following manuscript.Results The panel determined unique clinical trial designs tailored to different stages of cancer development—from premalignant to unresectable/metastatic—that can maximize the chance of capturing the effect of intratumoral immunotherapies. Design elements discussed included study type, patient stratification and exclusion criteria, indications of randomization, study arm determination, endpoints, biological sample collection, and response assessment with biomarkers and imaging. Populations to prioritize for the study of intratumoral immunotherapy, including stage, type of cancer and line of treatment, were also discussed along with common barriers to the development of these local treatments.Conclusions The SITC Intratumoral Immunotherapy Clinical Trials Expert Panel has identified key considerations for the design and implementation of studies that have the greatest potential to capture the effect of intratumorally delivered immunotherapies. With more effective and standardized trial designs, the potential of intratumoral immunotherapy can be realized and lead to regulatory approvals that will extend the benefit of these local treatments to the patients who need them the most.https://jitc.bmj.com/content/12/4/e008378.full |
| spellingShingle | Bart Neyns Mark Middleton Aurélien Marabelle Ignacio Melero Ke Liu Nina Bhardwaj Tanja D de Gruijl Jason Chesney Robert Coffin Howard Kaufman Diwakar Davar Jason J Luke Georgina V Long Kevin J Harrington Sherene Loi Thierry de Baere David J Pinato Matthew Fury Ciara M Kelly Joshua D Brody Robert H Andtbacka Gregory Goldmacher Anuradha D Khilnani Rahul A Sheth Stephen B Solomon Philippe Szapary Society for Immunotherapy of Cancer (SITC) recommendations on intratumoral immunotherapy clinical trials (IICT): from premalignant to metastatic disease Journal for ImmunoTherapy of Cancer |
| title | Society for Immunotherapy of Cancer (SITC) recommendations on intratumoral immunotherapy clinical trials (IICT): from premalignant to metastatic disease |
| title_full | Society for Immunotherapy of Cancer (SITC) recommendations on intratumoral immunotherapy clinical trials (IICT): from premalignant to metastatic disease |
| title_fullStr | Society for Immunotherapy of Cancer (SITC) recommendations on intratumoral immunotherapy clinical trials (IICT): from premalignant to metastatic disease |
| title_full_unstemmed | Society for Immunotherapy of Cancer (SITC) recommendations on intratumoral immunotherapy clinical trials (IICT): from premalignant to metastatic disease |
| title_short | Society for Immunotherapy of Cancer (SITC) recommendations on intratumoral immunotherapy clinical trials (IICT): from premalignant to metastatic disease |
| title_sort | society for immunotherapy of cancer sitc recommendations on intratumoral immunotherapy clinical trials iict from premalignant to metastatic disease |
| url | https://jitc.bmj.com/content/12/4/e008378.full |
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