{
  "abstract": "Background CD8 T cells mediate the effects of cancer immunotherapies. CD8 positron emission tomography (PET) imaging with [ 89Zr]Zr-berdoxam-crefmirlimab enables whole body CD8 cell assessment and has been shown to be safe in Phase I evaluation. The correlation between CD8 PET imaging parameters and the quantity of CD8 cells assessed by the gold standard of immunohistochemistry (IHC) is unknown.Methods The Phase II, prospective multicenter study (iCorrelate) tested the correlation between CD8 PET and CD8 cells by IHC of core needle biopsies from patients with solid tumors receiving immune checkpoint blockade. The safety of repeat CD8 PET was additionally analyzed.Results 49 patients had 70 biopsies (37 baseline and 33 on-treatment) for correlating CD8 PET with IHC. Standard uptake value mean of the biopsied tumor normalized to aorta showed a correlation with IHC of 0.49 (95% CI 0.26 to 0.59). The correlation was 0.71 (95% CI 0.48 to 0.85) in patients with renal cell carcinoma. Repeat CD8 PET imaging on-treatment was safe.Conclusions We found a modest correlation between CD8 PET with [ 89Zr]Zr-berdoxam-crefmirlimab and intratumoral CD8 cell counts, likely because core needle biopsies do not fully represent the intratumoral heterogeneity of the CD8 cell distribution. Continued research is essential to evaluate in vivo CD8 PET signals, autoradiography, and CD8 T-cell presence by IHC in fully resected tumors. Further studies investigating the correlation between CD8 PET and immunotherapy outcomes are necessary to determine whether CD8 PET imaging could become a valuable tool for guiding immunotherapy development and informing clinical decision-making.",
  "authors": [
    {
      "affiliations": [
        "Memorial Sloan Kettering Cancer Center, New York, New York, USA"
      ],
      "name": "Michael A Postow"
    },
    {
      "affiliations": [
        "Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, California, USA"
      ],
      "name": "Peter D Zang"
    },
    {
      "affiliations": [
        "City of Hope Comprehensive Cancer Center, Duarte, California, USA"
      ],
      "name": "Sumanta K Pal"
    },
    {
      "affiliations": [
        "Epidemiology-Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York, USA"
      ],
      "name": "Audrey Mauguen"
    },
    {
      "affiliations": [
        "Division of Nuclear Medicine and Molecular Imaging, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA"
      ],
      "name": "Michael Farwell"
    },
    {
      "affiliations": [
        "HonorHealth, Scottsdale, Arizona, USA"
      ],
      "name": "Michael Gordon"
    },
    {
      "affiliations": [
        "CARTI Cancer Center, Little Rock, Arkansas, USA"
      ],
      "name": "David Hays"
    },
    {
      "affiliations": [
        "Department of Radiation Oncology, City of Hope Beckman Research Institute and Medical Center, Duarte, California, USA"
      ],
      "name": "Jeffrey Y C Wong"
    },
    {
      "affiliations": [
        "University of Washington, Seattle, Washington, USA"
      ],
      "name": "Delphine Chen"
    },
    {
      "affiliations": [
        "Department of Molecular Imaging Departments of Radiology and Translational Genomics, Therapy Hoag Family Cancer Institute, Irvine Los Angeles, California, USA",
        "Department of Molecular Imaging Departments of Radiology and Translational Genomics, University of Southern California, Los Angeles, California, USA"
      ],
      "name": "Gary A Ulaner"
    },
    {
      "affiliations": [
        "MedStar Georgetown University Hospital, Washington, DC, USA"
      ],
      "name": "Giuseppe Esposito"
    },
    {
      "affiliations": [
        "University of Alabama at Birmingham Health System Authority, Birmingham, Alabama, USA"
      ],
      "name": "Jonathan McConathy"
    },
    {
      "affiliations": [
        "Department of Radiology, University of Iowa, Iowa city, Iowa, USA"
      ],
      "name": "Michael M Graham"
    },
    {
      "affiliations": [
        "Karmanos Cancer Institute, Detroit, Michigan, USA"
      ],
      "name": "Anthony F Shields"
    },
    {
      "affiliations": [
        "Department of Imaging, Dana-Farber Cancer Institute, Boston, Massachusetts, USA"
      ],
      "name": "Annick D Van den Abbeele"
    },
    {
      "affiliations": [
        "Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada"
      ],
      "name": "Marcus O Butler"
    },
    {
      "affiliations": [
        "USC Norris Comprehensive Cancer Center, Los Angeles, California, USA"
      ],
      "name": "Jacob S Thomas"
    },
    {
      "affiliations": [
        "Department of Urologic Oncology, Providence Saint John’s Health Center, Santa Monica, California, USA"
      ],
      "name": "Przemyslaw Twardowski"
    },
    {
      "affiliations": [
        "Takeda Pharmaceuticals, Cambridge, Massachusetts, USA"
      ],
      "name": "Jayant Narang"
    },
    {
      "affiliations": [
        "Oncology Cell Therapy and Therapeutic Area Unit, Waltham, Massachusetts, USA"
      ],
      "name": "Aman P Singh"
    },
    {
      "affiliations": [
        "Oncology Cell Therapy and Therapeutic Area Unit, Waltham, Massachusetts, USA"
      ],
      "name": "Agnish Dey"
    },
    {
      "affiliations": [
        "WRDM, Pfizer Inc, Tewksbury, Massachusetts, USA"
      ],
      "name": "Kevin P Maresca"
    },
    {
      "affiliations": [
        "Pfizer Inc, New York, New York, USA"
      ],
      "name": "Edmund Keliher"
    },
    {
      "affiliations": [
        "Clinical Pharmacology and Translational Sciences, Pfizer Oncology Division, La Jolla, California, USA"
      ],
      "name": "Feng Liu"
    },
    {
      "affiliations": [
        "AstraZeneca US, Wilmington, Delaware, USA"
      ],
      "name": "Guillaume Potdevin"
    },
    {
      "affiliations": [
        "AstraZeneca US, Wilmington, Delaware, USA"
      ],
      "name": "Guenter Schmidt"
    },
    {
      "affiliations": [
        "ImaginAb Inc, Inglewood, California, USA"
      ],
      "name": "William Le"
    },
    {
      "affiliations": [
        "ImaginAb Inc, Inglewood, California, USA"
      ],
      "name": "Ian Wilson"
    },
    {
      "affiliations": [
        "ImaginAb Inc, Inglewood, California, USA"
      ],
      "name": "Alessandro Mascioni"
    },
    {
      "affiliations": [
        "ImaginAb Inc, Inglewood, California, USA"
      ],
      "name": "Fang Jia"
    },
    {
      "affiliations": [
        "Radiology, Imaging Endpoints, Scottsdale, Arizona, USA"
      ],
      "name": "Ronald Korn"
    },
    {
      "affiliations": [
        "ImaginAb Inc, Inglewood, California, USA"
      ],
      "name": "Michael R Ferris"
    },
    {
      "affiliations": [
        "ImaginAb Inc, Inglewood, California, USA"
      ],
      "name": "Kristin Schmiedehausen"
    },
    {
      "affiliations": [
        "Memorial Sloan Kettering Cancer Center, New York, New York, USA"
      ],
      "name": "Neeta Pandit-Taskar"
    },
    {
      "affiliations": [
        "Medical Oncology, City of Hope National Medical Center, duarte, California, USA"
      ],
      "name": "Kim A Margolin"
    }
  ],
  "title": "CD8 PET imaging with [89Zr]Zr-berdoxam-crefmirlimab in patients with solid tumors: the Phase II iCorrelate study",
  "uid": "7021a96b-8276-58dd-8c5a-f13a7f8f8d7e"
}