Society for Immunotherapy of Cancer (SITC) consensus statement on essential biomarkers for immunotherapy clinical protocols
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.
Authors
- Joe Yeong
- Brian Paul Hobbs (ORCID: https://orcid.org/0000-0003-2189-5846)
- Elizabeth G. Hill (ORCID: https://orcid.org/0000-0003-0896-4106)
- Wim Vos (ORCID: https://orcid.org/0000-0003-0827-421X)
- Ryan J. Sullivan (ORCID: https://orcid.org/0000-0001-5344-6645)
- Isabella C. Glitza Oliva (ORCID: https://orcid.org/0000-0002-4530-7765)
- Genia Dubrovsky
- Sumit Kumar Subudhi (ORCID: https://orcid.org/0000-0001-5208-7732)
- Gary Kohanbash (ORCID: https://orcid.org/0000-0002-3953-8022)
- Leslie Cope (ORCID: https://orcid.org/0000-0002-4098-3289)
- Michael T. Lotze (ORCID: https://orcid.org/0000-0003-3988-5419)
- Iván Díaz-Padilla
- Elizabeth Garrett‐Mayer (ORCID: https://orcid.org/0000-0003-4709-0333)
- Barbara Seliger (ORCID: https://orcid.org/0000-0002-5544-4958)
- Janis M. Taube (ORCID: https://orcid.org/0000-0002-8273-4395)
- Tullia C. Bruno (ORCID: https://orcid.org/0000-0002-6433-0207)
- Chris H. Takimoto
- Susan Halabi (ORCID: https://orcid.org/0000-0003-4135-2777)
- Christian M. Capitini (ORCID: https://orcid.org/0000-0002-2276-6731)
- Yana George Najjar (ORCID: https://orcid.org/0000-0002-0138-1664)
- Carlo Bifulco (ORCID: https://orcid.org/0000-0003-1922-6977)
- Virgil Simons
- Holden T. Maecker (ORCID: https://orcid.org/0000-0003-0795-9946)
- Julie S. Deutsch (ORCID: https://orcid.org/0000-0002-8040-5205)
- Laura Q.M. Chow (ORCID: https://orcid.org/0000-0002-7237-017X)
- Tricia R. Cottrell (ORCID: https://orcid.org/0000-0003-2952-1830)
- Kristin G. Anderson (ORCID: https://orcid.org/0000-0001-9263-4438)
- Sacha Gnjatic (ORCID: https://orcid.org/0000-0001-5643-9520)
- Alaa M. Ali (ORCID: https://orcid.org/0000-0003-1813-515X)
- Deborah Collyar (ORCID: https://orcid.org/0000-0003-0886-0964)
- Codruța Chiuzan (ORCID: https://orcid.org/0000-0001-8169-5032)
- Saman Maleki Vareki (ORCID: https://orcid.org/0000-0002-9615-7779)
- Denise Goh (ORCID: https://orcid.org/0000-0003-4598-4181)
- Anthony R. Cillo (ORCID: https://orcid.org/0000-0002-3213-3129)
- Sarah Mullin (ORCID: https://orcid.org/0000-0002-5246-2202)
- Paola Grandi (ORCID: https://orcid.org/0000-0003-1538-6535)
- Phyllis Pettit Nassi
Institutions
- Agency for Science, Technology and Research (SG)
- Western University (CA)
- Carter Center (US)
- Roswell Park Comprehensive Cancer Center (US)
- Northwell Health (US)
- Advocates for Youth (US)
- American Society of Clinical Oncology (US)
- Feinstein Institute for Medical Research (US)
- The University of Texas MD Anderson Cancer Center (US)
- Harvard University (US)
- Johns Hopkins University (US)
- Medical University of South Carolina (US)
- University of Liège (BE)
- University of Pittsburgh (US)
- Queen's University (CA)
- University of Utah (US)
- Singapore General Hospital (SG)
- Johns Hopkins Medicine (US)
- Georgetown University Medical Center (US)
- Prostate Cancer Foundation (US)
- Huntsman Cancer Institute (US)
- Providence Portland Medical Center (US)
- Massachusetts General Hospital (US)
- MUSC Hollings Cancer Center (US)
- University of Wisconsin Carbone Cancer Center (US)
- IGM Biosciences (United States) (US)
- Duke Medical Center (US)
- UPMC Hillman Cancer Center (US)
- Neurological Surgery (US)
- Universitätsklinikum Brandenburg an der Havel (DE)
- Sidney Kimmel Comprehensive Cancer Center (US)
- University of Virginia Cancer Center
- Duke Cancer Institute
- Georgetown Lombardi Comprehensive Cancer Center
- University of Virginia (US)
- Institute of Molecular and Cell Biology (SG)
- The University of Texas at Austin (US)
- Stanford University (US)
- Icahn School of Medicine at Mount Sinai (US)
Publication Details
- Journal
- Journal for ImmunoTherapy of Cancer
- Published
- 2025-03-01
- DOI
- https://doi.org/10.1136/jitc-2024-010928
- Citations
- 28
- Primary Topic
- Cancer Immunotherapy and Biomarkers
- Type
- article
- Field-Weighted Citation Impact
- 28.23