Society for Immunotherapy of Cancer (SITC) recommendations on intratumoral immunotherapy clinical trials (IICT): from premalignant to metastatic disease

Society for Immunotherapy of Cancer (SITC) recommendations on intratumoral immunotherapy clinical trials (IICT): from premalignant to metastatic disease · SciRah

^aUPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, USA
^bHiFiBiO Therapeutics, Cambridge, Massachusetts, USA
^cTisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA
^dMarc and Jennifer Lipschultz Precision Immunology Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA
^eJames Graham Brown Cancer Center, University of Louisville, Louisville, Kentucky, USA
^fReplimune Inc, Woburn, Massachusetts, USA
^gCenter for Biotherapies In Situ (BIOTHERIS), INSERM CIC1428, Interventional Radiology Unit, Department of Medical Imaging, Gustave Roussy Cancer Center, University of Paris Saclay, Villejuif, France
^hCancer Biology and Immunology, Cancer Center Amsterdam, Amsterdam, Netherlands
ⁱCancer Immunology, Amsterdam Institute for Infection and Immunology, Amsterdam, Netherlands
^jDepartment of Medical Oncology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands
^kOncology Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, New York, USA
^lMerck & Co Inc, Rahway, New Jersey, USA
^mThe Institute of Cancer Research, The Royal Marsden National Institute for Health and Care Research Biomedical Research Centre, London, UK
ⁿAnkyra Therapeutics, Boston, Massachusetts, USA
^oDepartment of Surgery, Massachusetts General Hospital, Boston, Massachusetts, USA
^pDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA
^qMarengo Therapeutics, Inc, Cambridge, Massachusetts, USA
^rDivision of Cancer Research, Peter MacCallum Cancer Center, Melbourne, Victoria, Australia
^sThe Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Victoria, Australia
^tMelanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, North Sydney, New South Wales, Australia
^uCIMA, Universidad de Navarra, Pamplona, Spain
^vDepartment of Oncology, University of Oxford, Oxford, UK
^wDepartment of Medical Oncology, Universitair Ziekenhuis Brussel, Jette, Belgium
^xDepartment of Surgery and Cancer, Imperial College London, Hammersmith Hospital, London, UK
^yDivision of Oncology, Department of Translational Medicine, University of Piemonte Orientale, Novara, Italy
^zDepartment of Interventional Radiology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA
^aaChief of Interventional Radiology, Memorial Sloan Kettering Cancer Center, New York, New York, USA
^abProfessor of Radiology, Weill Cornell Medical College, New York, New York, USA
^acInterventional Oncology, Johnson & Johnson, New Brunswick, New Jersey, USA
^adCenter for Biotherapies In Situ (BIOTHERIS), INSERM CIC1428, Department for Therapeutic Innovation and Early Phase Trials (DITEP), Gustave Roussy Cancer Center, University of Paris Saclay, Villejuif, France
✉Corresponding author

Abstract

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.

TL;DRWith 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. (Semantic Scholar)

Society for Immunotherapy of Cancer (SITC) recommendations on intratumoral immunotherapy clinical trials (IICT): from premalignant to metastatic disease

Abstract

Plain-language summary

Discussion