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...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2024-04-01
|
| Series: | Journal for ImmunoTherapy of Cancer |
| Online Access: | https://jitc.bmj.com/content/12/4/e008378.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1846168362737991680 |
|---|---|
| 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. |
| format | Article |
| id | doaj-art-c46bb380ab4f4bb8bdb94dd95f2f7c6b |
| institution | Kabale University |
| issn | 2051-1426 |
| language | English |
| publishDate | 2024-04-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | Journal for ImmunoTherapy of Cancer |
| spelling | doaj-art-c46bb380ab4f4bb8bdb94dd95f2f7c6b2024-11-14T04:00:14ZengBMJ 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 Szapary2523 Department of Medical Oncology, Universitair Ziekenhuis Brussel, Jette, Belgium22 Department of Oncology, University of Oxford, Oxford, UKDrug Development Department, Gustave Roussy, Villejuif, Île-de-France, FranceImmunology and Immunotherapy, Centro de Investigación Médica Aplicada, Pamplona, Spain17 Marengo Therapeutics, Inc, Cambridge, Massachusetts, USA3 Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USADepartment of Medical Oncology, Amsterdam UMC location Vrije Universiteit Amsterdam, Amsterdam, Netherlands5 James Graham Brown Cancer Center, University of Louisville, Louisville, Kentucky, USA6 Replimune Inc, Woburn, Massachusetts, USAAnkyra Therapeutics, Cambridge, Massachusetts, USAUPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, USAUniversity of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA4 Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, AustraliaDivision of Radiotherapy and Imaging, The Institute of Cancer Research, London, UK18 Division of Cancer Research, Peter MacCallum Cancer Center, Melbourne, Victoria, Australia7 Center for Biotherapies In Situ (BIOTHERIS), INSERM CIC1428, Interventional Radiology Unit, Department of Medical Imaging, Gustave Roussy Cancer Center, University of Paris Saclay, Villejuif, FranceDepartment of Surgery & Cancer, Imperial College London, London, UK11 Oncology Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, New York, USA16 Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA4 Marc and Jennifer Lipschultz Precision Immunology Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA2 HiFiBiO Therapeutics, Cambridge, Massachusetts, USA12 Merck & Co Inc, Rahway, New Jersey, USA12 Merck & Co Inc, Rahway, New Jersey, USA26 Department of Interventional Radiology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA27 Chief of Interventional Radiology, Memorial Sloan Kettering Cancer Center, New York, New York, USA29 Interventional 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 |
| work_keys_str_mv | AT bartneyns societyforimmunotherapyofcancersitcrecommendationsonintratumoralimmunotherapyclinicaltrialsiictfrompremalignanttometastaticdisease AT markmiddleton societyforimmunotherapyofcancersitcrecommendationsonintratumoralimmunotherapyclinicaltrialsiictfrompremalignanttometastaticdisease AT aurelienmarabelle societyforimmunotherapyofcancersitcrecommendationsonintratumoralimmunotherapyclinicaltrialsiictfrompremalignanttometastaticdisease AT ignaciomelero societyforimmunotherapyofcancersitcrecommendationsonintratumoralimmunotherapyclinicaltrialsiictfrompremalignanttometastaticdisease AT keliu societyforimmunotherapyofcancersitcrecommendationsonintratumoralimmunotherapyclinicaltrialsiictfrompremalignanttometastaticdisease AT ninabhardwaj societyforimmunotherapyofcancersitcrecommendationsonintratumoralimmunotherapyclinicaltrialsiictfrompremalignanttometastaticdisease AT tanjaddegruijl societyforimmunotherapyofcancersitcrecommendationsonintratumoralimmunotherapyclinicaltrialsiictfrompremalignanttometastaticdisease AT jasonchesney societyforimmunotherapyofcancersitcrecommendationsonintratumoralimmunotherapyclinicaltrialsiictfrompremalignanttometastaticdisease AT robertcoffin societyforimmunotherapyofcancersitcrecommendationsonintratumoralimmunotherapyclinicaltrialsiictfrompremalignanttometastaticdisease AT howardkaufman societyforimmunotherapyofcancersitcrecommendationsonintratumoralimmunotherapyclinicaltrialsiictfrompremalignanttometastaticdisease AT diwakardavar societyforimmunotherapyofcancersitcrecommendationsonintratumoralimmunotherapyclinicaltrialsiictfrompremalignanttometastaticdisease AT jasonjluke societyforimmunotherapyofcancersitcrecommendationsonintratumoralimmunotherapyclinicaltrialsiictfrompremalignanttometastaticdisease AT georginavlong societyforimmunotherapyofcancersitcrecommendationsonintratumoralimmunotherapyclinicaltrialsiictfrompremalignanttometastaticdisease AT kevinjharrington societyforimmunotherapyofcancersitcrecommendationsonintratumoralimmunotherapyclinicaltrialsiictfrompremalignanttometastaticdisease AT shereneloi societyforimmunotherapyofcancersitcrecommendationsonintratumoralimmunotherapyclinicaltrialsiictfrompremalignanttometastaticdisease AT thierrydebaere societyforimmunotherapyofcancersitcrecommendationsonintratumoralimmunotherapyclinicaltrialsiictfrompremalignanttometastaticdisease AT davidjpinato societyforimmunotherapyofcancersitcrecommendationsonintratumoralimmunotherapyclinicaltrialsiictfrompremalignanttometastaticdisease AT matthewfury societyforimmunotherapyofcancersitcrecommendationsonintratumoralimmunotherapyclinicaltrialsiictfrompremalignanttometastaticdisease AT ciaramkelly societyforimmunotherapyofcancersitcrecommendationsonintratumoralimmunotherapyclinicaltrialsiictfrompremalignanttometastaticdisease AT joshuadbrody societyforimmunotherapyofcancersitcrecommendationsonintratumoralimmunotherapyclinicaltrialsiictfrompremalignanttometastaticdisease AT roberthandtbacka societyforimmunotherapyofcancersitcrecommendationsonintratumoralimmunotherapyclinicaltrialsiictfrompremalignanttometastaticdisease AT gregorygoldmacher societyforimmunotherapyofcancersitcrecommendationsonintratumoralimmunotherapyclinicaltrialsiictfrompremalignanttometastaticdisease AT anuradhadkhilnani societyforimmunotherapyofcancersitcrecommendationsonintratumoralimmunotherapyclinicaltrialsiictfrompremalignanttometastaticdisease AT rahulasheth societyforimmunotherapyofcancersitcrecommendationsonintratumoralimmunotherapyclinicaltrialsiictfrompremalignanttometastaticdisease AT stephenbsolomon societyforimmunotherapyofcancersitcrecommendationsonintratumoralimmunotherapyclinicaltrialsiictfrompremalignanttometastaticdisease AT philippeszapary societyforimmunotherapyofcancersitcrecommendationsonintratumoralimmunotherapyclinicaltrialsiictfrompremalignanttometastaticdisease |