Harnessing imaging tools to guide immunotherapy trials: summary from the National Cancer Institute Cancer Imaging Steering Committee workshop.

As the immuno-oncology field continues the rapid growth witnessed over the past decade, optimising patient outcomes requires an evolution in the current response-assessment guidelines for phase 2 and 3 immunotherapy clinical trials and clinical care. Additionally, investigational tools-including image analysis of standard-of-care scans (such as CT, magnetic resonance, and PET) with analytics, such as radiomics, functional magnetic resonance agents, and novel molecular-imaging PET agents-offer promising advancements for assessment of immunotherapy. To document current challenges and opportunities and identify next steps in immunotherapy diagnostic imaging, the National Cancer Institute Clinical Imaging Steering Committee convened a meeting with diverse representation among imaging experts and oncologists to generate a comprehensive review of the state of the field.

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Declaration of interests EGEdV reports institutional financial support for clinical trials or contracted research from Amgen, Genentech, Roche, CytomX, G1 Therapeutics, Bayer, Synthon, Servier, Regeneron, Crescendo Biologics, GE Healthcare, and AstraZeneca; institutional financial support for advisory boards and consultancy from National Surgical Adjuvant Breast and Bowel Project, Daiichi Sankyo, and Crescendo Biologics; and non-financial interests, including non-renumerated activities and public positions as a member of the European Society for Medical Oncology (ESMO)–Magnitude of Clinical Benefit Scale working party, chair of the ESMO Cancer Medicines Working Group, co-chair of the RECIST committee, and a member of the expert panel for the selection of WHO Essential Medicine List. MDF reports institutional grant or contract payments from Merck, Bristol Myers Squibb, ImaginAb, and Carisma Therapeutics, and consulting fees and meeting and travel support from ImaginAb. DL reports stock ownership in Bristol Myers Squibb. UM reports grants, royalties and license, consulting fees, meeting and travel support, licensed patents, leadership interest, stock, receipt of materials, and other financial or non-financial interests in CytoSite Biopharma. TYP reports grants or contracts from the Pediatric Brain Tumor Consortium Neuroimaging Center; royalties from Springer; and honoraria for grand rounds, visiting professorships, and invited lectures from Cornell University, University of California San Francisco, and University of Rochester. DP reports grants to or contracts with his institution from Siemens, 511 Pharma, Nordic nanovector, Lantheus, and Fusion Pharmaceuticals; royalties or licenses to him and his institution from Trevarx; consulting fees from Siemens, Fusion Pharmaceuticals, 511 Pharma, Ipsen, Bayer, Molecular Targeting Technologies, and Curium; patents from At-211 parthanatrace; participation on an Isotope Technologies Munich (ITM) data and safety monitoring committee; and stock with Molecular Targeting Technologies and Trevarx. LS reports institutional grants or contracts from Johnson & Johnson, patents from Varian Medial Systems, and data and safety monitoring board or advisory board participation with Merck, BMS, and Regeneron. YT provided medical writing assistance funded by NCI. AJT reports an institutional research grant from the Cystic Fibrosis Foundation, royalties from Elsevier, consulting fees from Applied Radiology, travel support from KLAS Research, and unpaid leadership roles in the Society for Imaging Informatics in Medicine and the Society for Pediatric Radiology. RLW reports grants or contracts from Bristol Myers Squibb, Bayer, Actinium Pharmaceuticals, ITM, Siemens, and NIH; consulting fees from Seno medical, Actinium Pharmaceuticals, and Clarity Pharmaceuticals; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from ITM, Voximetry, American College of Nuclear Medicine, and NIH (not for this workshop or manuscript); support for meetings and travel from the Society of Nuclear Medicine and the World Theranostics Conference; data and safety monitoring board and advisory board participation from Bayer; a recent past-presidency at Society of Nuclear Medicine and Molecular Imaging; and stock in Clarity Pharmaceuticals and Voximetry. JW reports grants from Bristol Myers Squibb and Sephora; institutional royalties for xenogeneic DNA vaccines, Newcastle disease viruses for cancer therapy, myeloid-derived suppressor cell assay, and prediction of responsiveness to treatment with immunomodulatory therapeutics and method of monitoring abscopal effects during such treatment; licenses for anti-PD1 antibodies, anti-CTLA4 antibodies, and anti-GITR antibodies, and methods of use thereof; consulting fees from Amgen, Apricity, Ascentage Pharma, Astellas, AstraZeneca, Bicara Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, CellCarta, Chugai, Daiichi Sankyo, Dragonfly, Georgiamune, Idera, Imvaq, Larkspur, Maverick Therapeutics, Merck, Psioxus, Recepta, Trishula, Sellas, Surface Oncology, and Werewolf therapeutics; support for meetings and travel from Society for Immunotherapy of Cancer (SITC) and Parker Institute for Cancer Immunotherapy; a leadership or fiduciary role in SITC; and stock in Apricity, CellCarta, Ascentage, Beigene, Imvaq, Linneaus, Georgiamune, Maverick, Tizona Pharma, and Trieza. JW also reports patents for recombinant poxviruses for cancer immunotherapy, phosphatidylserine targeting agents, immunosuppressive follicular helper-like T cells modulated by immune checkpoint blockade, identifying and treating subjects at risk for checkpoint blockade therapy-associated colitis, CAR(+) T cells targeting differentiation antigens as means to treat cancer, anti-CD40 agonist monoclonal antibody fused to monophosphoryl lipid A for cancer therapy, and engineered vaccinia viruses for cancer immunotherapy. AMW reports consulting fees, a leadership or fiduciary role (board member), and stock options in ImaginAb; and speaker honoraria payments from Roche and AstraZeneca. All other authors declare no competing interests.