Essential Biomarkers Initiative

IO Essential Biomarkers Initiative 

Recognizing the major developments in clinical oncology over the last twelve years and the value of standardized datasets, The Society for Immunotherapy of Cancer (SITC) is working to provide data- and consensus-based recommendations for biomarker studies in early-phase immunotherapy clinical trials.  

SITC has developed and disseminated a commentary and consensus-level manuscript in the Journal for ImmunoTherapy of Cancer (JITC), and plans to update the manuscript as evidence and applicable laboratory protocols for new validated biomarkers become available. 

Consensus Manuscript

The Society for Immunotherapy of Cancer (SITC) proposes a definition and listing of essential biomarkers recommended for inclusion in all such protocols. These recommendations are based on consensus provided by the SITC Clinical Immuno-Oncology Network (SCION) faculty with input from the SITC Pathology and Biomarker Committees and the JITC readership. 

The consensus manuscript delineates biomarkers into three tiers:

  • Essential tier: these biomarkers should be included in all relevant trials and are selected based on:
    • Strong evidence of clinical relevance and/or biological relevance
    • Broad support across tumor types and treatment approaches
    • High feasibility (i.e. standardized testing methods, routine or readily available testing)
  • Eligibility tier: captures feasible markers that are relevant in specific contexts (e.g., specific immunotherapy targets)
  • Emergent tier: candidate markers with limited evidence of clinical utility or lacking a well-described, analytically validated assay, with the expectation that they will eventually establish their value and move into the essential or eligibility class, or else drop out of consideration

READ THE Manuscript

Past Publications

2024 Commentary in the Journal for ImmunoTherapy of Cancer (JITC):

Organizers

Tricia Cottrell

Tricia R. Cottrell, MD, PhD
Queen’s University Sinclair Cancer Research Institute

Michael Lotze

Michael T. Lotze, MD
UPMC Hillman Cancer Center

Contributors

Tricia R. Cottrell, MD, PhD
Queen’s University Sinclair Cancer Research Institute

Michael T. Lotze, MD
UPMC Hillman Cancer Center

Alaa Ali, MD, MSC
MedStar Georgetown University Hospital

Carlo B. Bifulco, MD
Providence Portland Medical Center

Christian M. Capitini, MD
University of Wisconsin-Madison

Laura Q. M. Chow, MD, FRCPC
The University of Texas at Austin

Anthony R. Cillo, PhD
University of Pittsburgh

Deborah Collyar
Patient Advocates In Research (PAIR)

Leslie Cope, PhD
The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine

Julie Stein Deutsch, MD
Johns Hopkins School of Medicine

Genia Dubrovsky, MD
University of Pittsburgh

Sacha Gnjatic, PhD
Icahn School of Medicine at Mount Sinai

Denise Goh
Institute of Molecular and Cell Biology (IMCB), Agency of Science, Technology and Research (A*STAR)

Susan Halabi, PhD
Duke University

Gary Kohanbash, PhD
University of Pittsburgh

Holden T. Maecker, PhD
Stanford University

Saman Maleki Vareki, PhD
Western University

Sarah Mullin, PhD, MS
Roswell Park Comprehensive Cancer Center

Barbara Seliger, MD, PhD
Institute of Translational Immunology

Janis Taube, MD
Johns Hopkins School of Medicine

Wim Vos, MSc, PhD
Radiomics

Joe Yeong, MD, PhD, Mmed
Singapore General Hospital

Kristin G. Anderson, PhD
University of Virginia

Tullia C. Bruno, PhD
University of Pittsburgh

Codruta Chiuzan, PhD
Feinstein Institutes for Medical Research, Northwell Health

Ivan Diaz-Padilla, MD, PhD
GSK

Elizabeth Garrett-Mayer, PhD
American Society of Clinical Oncology

Isabella C. Glitza Oliva, MD, PhD
The University of Texas MD Anderson Cancer Center

Paola Grandi, PhD
Adze Biotechnology Inc

Elizabeth G. Hill, PhD
Medical University of South Carolina

Brian P. Hobbs, PhD
Dell Medical School, The University of Texas

Yana G. Najjar, MD
UPMC Hillman Cancer Center

Phyllis Pettit Nassi, MSW
Huntsman Cancer Institute University of Utah

Virgil H. Simons, MPA
The Prostate Net, Inc.

Sumit K. Subudhi, MD, PhD
The University of Texas MD Anderson Cancer Center

Ryan J. Sullivan, MD
Harvard Medical School, Massachusetts General Hospital

Chris H. Takimoto, MD, PhD
IGM Biosciences