Overview & Publications

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, 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. 

SITC proposes that biomarkers in the essential tier should be included in all relevant trials. Essential biomarkers are selected based on:

1. Strong evidence of clinical relevance and/or biological relevance,
2. Broad support across tumor types and treatment approaches, and 
3. High feasibility (i.e. standardized testing methods, routine or readily available testing).

The eligibility tier captures feasible markers that are relevant in specific contexts (e.g., specific immunotherapy targets).

Candidate markers with limited evidence of clinical utility or lacking a well-described, analytically validated assay are relegated to the emergent tier, with the expectation that they will eventually establish their value and move into the essential or eligibility class, or else drop out of consideration. Furthermore, SITC provides criteria for evaluation of promising emergent biomarkers to allow promotion to essential based on sound scientific principles and guided by suitable fiscal support.

Novel biomarkers may render previously essential biomarkers obsolete, triggering removal from the essential list. 

READ THE COMMENTARY

READ THE CONSENSUS MANUSCRIPT

Organizers & Authors

• 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