Society for Immunotherapy of Cancer (SITC) consensus statement on essential biomarkers for immunotherapy clinical protocols

Society for Immunotherapy of Cancer (SITC) consensus statement on essential biomarkers for immunotherapy clinical protocols · SciRah

^aQueen’s University Sinclair Cancer Research Institute, Kingston, Ontario, Canada
^bQueen's University Sinclair Cancer Research Institute, Kingston, Ontario, Canada
^cUPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, USA
^dStem Cell Transplant and Cellular Immunotherapy Program, Georgetown Lombardi Comprehensive Cancer Center, Washington, DC, Washington, DC, USA
^eEarle A. Chiles Research Institute, Providence Cancer Institute, Portland, Oregon, USA
^fUniversity of Wisconsin School of Medicine and Public Health and Carbone Cancer Center, Madison, Wisconsin, USA
^gThe University of Texas at Austin, Austin, Texas, USA
^hDepartment of Immunology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
ⁱPatient Advocates In Research (PAIR), Danville, California, USA
^jThe Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, Maryland, USA
^kJohns Hopkins School of Medicine, Baltimore, Maryland, USA
^lIcahn School of Medicine at Mount Sinai, New York, New York, USA
^mInstitute of Molecular and Cell Biology (IMCB), Agency of Science, Technology and Research (A*STAR), Singapore
ⁿDuke School of Medicine and Duke Cancer Institute, Durham, North Carolina, USA
^oDepartment of Neurological Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
^pStanford University School of Medicine, Stanford, California, USA
^qDepartment of Oncology and Pathology and Laboratory Medicine, Western University, London, Ontario, Canada
^rRoswell Park Comprehensive Cancer Center, Buffalo, New York, USA
^sCampus Brandenburg an der Havel, Brandenburg Medical School, Halle, Germany
^tRadiomics.bio, Liège, Belgium
^uDepartment of Anatomical Pathology, Singapore General Hospital, Singapore
^vDepartment of Microbiology, Immunology and Cancer Biology, Department of Obstetrics and Gynecology, Beirne B. Carter Center for Immunology Research and the University of Virginia Comprehensive Cancer Center, University of Virginia, Charlottesville, Virginia, USA
^wCancer Immunology and Immunotherapy Program, UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, USA
^xTumor Microenvironment Center, Hillman Cancer Center, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
^yInstitute of Health System Science, Feinstein Institutes for Medical Research, Northwell Health, Manhasset, New York, USA
^zGSK Oncology Research Unit, GSK, Baar, Zug, Switzerland
^aaAmerican Society of Clinical Oncology, Alexandria, Virginia, USA
^abThe University of Texas MD Anderson Cancer Center, Houston, Texas, USA
^acAdze Biotech Inc, Cambridge, Massachusetts, USA
^adHollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina, USA
✉Corresponding author

Abstract

Immunotherapy of cancer is now an essential pillar of treatment for patients with many individual tumor types. Novel immune targets and technical advances are driving a rapid exploration of new treatment strategies incorporating immune agents in cancer clinical practice. Immunotherapies perturb a complex system of interactions among genomically unstable tumor cells, diverse cells within the tumor microenvironment including the systemic adaptive and innate immune cells. The drive to develop increasingly effective immunotherapy regimens is tempered by the risk of immune-related adverse events. Evidence-based biomarkers that measure the potential for therapeutic response and/or toxicity are critical to guide optimal patient care and contextualize the results of immunotherapy clinical trials. Responding to the lack of guidance on biomarker testing in early-phase immunotherapy clinical trials, we propose a definition and listing of essential biomarkers recommended for inclusion in all such protocols. These recommendations are based on consensus provided by the Society for Immunotherapy of Cancer (SITC) Clinical Immuno-Oncology Network (SCION) faculty with input from the SITC Pathology and Biomarker Committees and the Journal for ImmunoTherapy of Cancer readership. A consensus-based selection of essential biomarkers was conducted using a Delphi survey of SCION faculty. Regular updates to these recommendations are planned. The inaugural list of essential biomarkers includes complete blood count with differential to generate a neutrophil-to-lymphocyte ratio or systemic immune-inflammation index, serum lactate dehydrogenase and albumin, programmed death-ligand 1 immunohistochemistry, microsatellite stability assessment, and tumor mutational burden. Inclusion of these biomarkers across early-phase immunotherapy clinical trials will capture variation among trials, provide deeper insight into the novel and established therapies, and support improved patient selection and stratification for later-phase clinical trials.

TL;DRThe inaugural list of essential biomarkers includes complete blood count with differential to generate a neutrophil-to-lymphocyte ratio or systemic immune-inflammation index, serum lactate dehydrogenase and albumin, programmed death-ligand 1 immunohistochemistry, microsatellite stability assessment, and tumor mutational burden. (Semantic Scholar)

Society for Immunotherapy of Cancer (SITC) consensus statement on essential biomarkers for immunotherapy clinical protocols

Abstract

Plain-language summary

Discussion