ArticleJournal for immunotherapy of cancer2025
Society for Immunotherapy of Cancer (SITC) consensus statement on essential biomarkers for immunotherapy clinical protocols.
Article in Journal for immunotherapy of cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 2 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
30 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- PD-1/PD-L1 inhibitors plus chemotherapy versus chemotherapy alone for ARPI-pretreated and chemotherapy-naive metastatic castration-resistant prostate cancer: a pooled analysis of KEYNOTE-921 and CheckMate 7DX trials.International urology and nephrology · 2026Pooled it
- Updated pan-tumor guidelines for neoadjuvant scoring of pathologic response: a joint SITC and INMC effort.Annals of oncology : official journal of the European Society for Medical Oncology · 2026Guideline
- Final results of ANICCA-Class II, a single arm, open-label phase II trial assessing nivolumab in tissue-specific class II expressing metastatic microsatellite stable colorectal cancer, with a parallel assessment of the immunoscore-immune checkpoint as a predictive biomarker for single-agent anti-PD-1.Journal for immunotherapy of cancer · 2025Trial
- Analysis of treatment-free survival of patients with advanced melanoma receiving nivolumab as monotherapy or in combination with relatlimab in RELATIVITY-047.Journal for immunotherapy of cancer · 2025Trial
- Circulating proteins as biomarkers of response to cancer immunotherapy (Review).International journal of oncology · 2026Review
- Therapeutic repurposing of old drugs to modulate the tumor immune microenvironment and enhance immunotherapy efficacy.Journal of pharmaceutical analysis · 2026Review
- Anthraquinone-Loaded Liposomes for TAM Reprogramming in Triple-Negative Breast Cancer: Mechanistic Rationale, Delivery Logic, and Translational Challenges.Pharmaceutics · 2026Review
- A Hypoxia-Apoptosis Stress-Adaptation State Defines Immune-Low Melanoma and Predicts Metastatic Risk.Cancers · 2026Article
- Peripheral blood IFN-γ-producing T-cell subsets and soluble IL-2 receptor as independent prognostic biomarkers in NSCLC treated with immune checkpoint inhibitor-based therapy.Discover oncology · 2026Article
- Pan-tumor harmonization of pathologic response assessment for standardized data collection in neoadjuvant trials (PATHdata): results of a Society for Immunotherapy of Cancer multi-institutional reproducibility study.Annals of oncology : official journal of the European Society for Medical Oncology · 2026Article
- Conventional type-1 DC density is associated with checkpoint inhibitor response across multiple types of cancer.The Journal of clinical investigation · 2026Article
- Immune Checkpoint Inhibitors and Bone Health: Mechanisms, Clinical Implications, and Emerging Perspectives on Bone Fragility.Current osteoporosis reports · 2026Review
- The role of deubiquitinase USP33 in colorectal cancer tumorigenesis and its potential as a therapeutic target predictor.Discover oncology · 2026Review
- Integrin-linked kinase (ILK) in hematologic malignancies: Bridging molecular mechanisms to therapeutic innovation.BioImpacts : BI · 2026Review
- Late-phase strategies to overcome limitations of PD-1/PD-L1 therapy: a clinical development trajectory through 2030.Frontiers in oncology · 2026Review
- Immunotherapy in Asia: current insights and prospects in Southeast Asia and Malaysia.Frontiers in oncology · 2026Review
- Peripheral blood biomarkers in PD-1/PD-L1 immunotherapy: distinguishing predictive from prognostic biomarkers.Frontiers in immunology · 2026Review
- Harnessing Dietary Tryptophan: Bridging the Gap Between Neurobiology and Psychiatry in Depression Management.International journal of molecular sciences · 2026Review
- Tumor-infiltrating lymphocyte therapy in triple-negative breast cancer: from mechanistic exploration to clinical translation.Frontiers in immunology · 2026Review
- Recent advances in dissolving microneedles for breast cancer immunotherapy: local delivery and tumor microenvironment remodeling.Frontiers in immunology · 2026Review
Corrections and comments
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Authors and funding
37 authors.
Funding
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.
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