Cited by 1,192Cancer Immunotherapy and BiomarkersImmunotherapy and Immune ResponsesCancer Genomics and Diagnostics

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The Challenges of Tumor Mutational Burden as an Immunotherapy Biomarker

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Jardim, Denis L., Goodman, Aaron, de Melo Gagliato, Debora, Kurzrock, Razelle·2021·Cancer Cell

DOI 10.1016/j.ccell.2020.10.001PMC PMC7878292

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Abstract

Tumor mutational burden (TMB) reflects cancer mutation quantity. Mutations are processed to neo-antigens and presented by major histocompatibility complex (MHC) proteins to T cells. To evade immune eradication, cancers exploit checkpoints that dampen T cell reactivity. Immune checkpoint inhibitors (ICIs) have transformed cancer treatment by enabling T cell reactivation; however, response biomarkers are required, as most patients do not benefit. Higher TMB results in more neo-antigens, increasing chances for T cell recognition, and clinically correlates with better ICI outcomes. Nevertheless, TMB is an imperfect response biomarker. A composite predictor that also includes critical variables, such as MHC and T cell receptor repertoire, is needed.

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“Tumors with a higher TMB tend to have more neoantigens,potentiallyprovidingtheimmunesystemwithabroaderrange oftargetsinresponsetoimmunotherapy 50 .”
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“TMB has been extensively studied as a predictive biomarker for response to ICI (18, 19) and is used clinically to guide ICI treatment (20), though challenges remain in terms of its general implementation across cancer types and individuals (21).”
THOR: a TMB heterogeneity-adaptive optimization model predicts immunotherapy response using clonal genomic features in group-structured data
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“TMB and MSI are two closely related biomarkers that play important roles in tumor diagnosis, treatment, and prognosis assessment (33, 34).”
Integrated Multi-Omics Analysis Unveils Distinct Molecular Subtypes and a Robust Immune–Metabolic Prognostic Model in Clear Cell Renal Cell Carcinoma
Zhu, Y., Yu, S., Yang, D., Tian, Y., Liu, Y., & Du, W. (2025) · International Journal of Molecular Sciences · doi:10.3390/ijms26073125 · Cited by 8
“Boxplots were employed to compare the expression levels of immune check-point genes between high-risk and low-risk groups, highlighting significant differences ( p 1 × 10 − 5 TMB was calculated using somatic mutation data from TCGA and expressed as mutations per megabase [46].”
Alterations in genomic features and the tumour immune microenvironment predict immunotherapy outcomes in advanced biliary tract cancer patients
Huang, C., Qiu, Z., Huang, H., Xiao, X., Du, F., Ji, J., Xu, X., Jiang, X., Wang, Y., & Gao, C. (2025) · British Journal of Cancer · doi:10.1038/s41416-025-03011-7 · Cited by 8
“In the future, the identi ﬁ cation of reliable predictive biomarkers for immunotherapy response is anticipated to facilitate more precise patient strati ﬁ cation, thereby enhancing therapeutic ef ﬁ cacy and improving clinical outcomes.”
Proteogenomic characterization reveals that lipid droplet formation promotes esophageal squamous cell cancer progression
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“TMB reflects the overall quantity of somatic mutations within a tumor genome and has emerged as a potential biomarker for prognostic assessment and immunotherapy response prediction [70].”
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“419 Research into novel biomarkers and predictive signatures continues.”
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Peripheral Blood Markers Predictive of Progression-Free Survival in Advanced Esophageal Squamous Cell Carcinoma Patients Treated With PD-1 Inhibitors Plus Chemotherapy as First-Line Therapy
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Comprehensive Analysis Reveals PTK6 as a Prognostic Biomarker Involved in the Immunosuppressive Microenvironment in Breast Cancer
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“…burden (TMB), which refers to the number of somatic coding errors like base substitutions, insertions, or deletions that occur across one million bases, is considered to be a promising indicator for predicting the patient ’ s level of responsiveness to immune checkpoint blockade (ICB) [26, 27].”
An Angiogenic Gene Signature for Prediction of the Prognosis and Therapeutic Responses of Hepatocellular Carcinoma
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Background
PTPRD/PTPRT mutation correlates to treatment outcomes of immunotherapy and immune landscape in pan-cancers
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Identification and validation of a ferroptosis-related signature for prediction of the prognosis and tumor microenvironment in patients with chromophobe renal cell carcinoma
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BackgroundResult
ANO6 is a reliable prognostic biomarker and correlates to macrophage polarization in breast cancer
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“[22] Pearson correlation test was also adopted to assess the association of ANO6 expression with TMB and MSI scores.”
Method
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Neoantigen-specific T cell help outperforms non-specific help in multi-antigen DNA vaccination against cancer
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Divergent outcomes of anti-PD-L1 treatment coupled with host-intrinsic differences in TCR repertoire and distinct T cell activation states in responding versus non-responding tumors
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External quality assessment (EQA) for tumor mutational burden: results of an international IQN path feasibility pilot scheme
Abate, R. E., Cheetham, M. H., Fairley, J. A., Pasquale, R., Sacco, A., Wolstenholme, N., Deans, Z. C., Patton, S. J., & Normanno, N. (2022) · Archiv für Pathologische Anatomie und Physiologie und für Klinische Medicin · doi:10.1007/s00428-022-03444-y · Cited by 8
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“TMB was commonly regarded as an indicator for immune checkpoint blockade (ICB) in BC, lung cancer and melanoma (Fusco et al., 2021; Jardim et al., 2021; McGrail et al., 2021).”
Background
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Background
PRKCSH serves as a potential immunological and prognostic biomarker in pan-cancer
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“TMB has been recently considered a potential predictive biomarker of immunotherapy (Picard et al., 2020; Jardim et al., 2021; Rizzo et al., 2021).”
Background
Neoadjuvant PD-1 Plus Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma
Qian, T., Liu, D., Cao, G., Chen, Z., & Zhang, Q. (2024) · Technology in Cancer Research & Treatment · doi:10.1177/15330338241231610 · Cited by 7
“15 In clinical practice, a certain level of TMB expression has been found in patients with esophageal cancer.”
Background
Higher tumor mutational burden and PD-L1 expression correlate with shorter survival in hematologic malignancies
Jeong, A., Trando, A., Thomas, S. D., Riviere, P. J., Sakowski, P. J., Sokol, E. S., Goodman, A. M., & Kurzrock, R. (2024) · Therapeutic Advances in Medical Oncology · doi:10.1177/17588359241273053 · Cited by 7
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c-MET is an important marker for acid-driven metastasis and anti-immune in colorectal cancer
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“100 Therefore, TNBC can be seen as a good candidate for not only immunotherapy, but also for vaccine therapy.”
Migrasome Marker Epidermal Growth Factor Domain-Specific O-GlcNAc Transferase: Pan-Cancer Angiogenesis Biomarker and the Potential Role of circ_0058189/miR-130a-3p/EOGT Axis in Hepatocellular Carcinoma Progression and Sorafenib Resistance
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“At the same time, the development of novel biomarkers, including tumor mutational burden (TMB) [10], cell surface proteins such as Nectin-4 [11] or trophoblast cell-surface antigen 2 (TROP-2) [12], as well as immune-related signatures, reflects an expanding focus on multidimensional tumor profiling…”
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“…- c e ll l u n g c a n c e r , between ctDNA decline and T-cell expansion in responders [67], while the neoantigen burden reflected by bTMB must be coupled with competent major histocompatibility complex (MHC)-mediated presentation and a diverse T TCR repertoire for effective immune targeting [68].”
Ultrasensitive ctDNA monitoring reveals early predictors of immunotherapy response in advanced cancer
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“Currentpredictivebiomarkers, includingmicrosatelliteinstability(MSI)status 1 , PD-L1 expression 2 and tumor mutation burden (TMB) 3 , have shown limitations in predicting treatment response and duration of response, and conventional imaging techniques may not accurately assess therapeutic outcomes,…”
Influential

Authors: Jardim, D. L., Goodman, A., de Melo Gagliato, D., & Kurzrock, R.
Affiliations: Hospital Sírio-Libanês (BR)
University of California San Diego (US)
Corresponding author: Kurzrock, Razelle
ORCID: Jardim, Denis L.
Goodman, Aaron
Kurzrock, Razelle
Venue: Cancer Cell
Publisher: Elsevier BV
Published: 2021-02
Volume: 39
Issue: 2
Pages: 154-173
ISSN: 1535-6108 (ISSN-L)
DOI: 10.1016/j.ccell.2020.10.001
PMC: PMC7878292
OpenAlex: W3097803258
Cited by: 1,192
References: 151
Citations by year: 2026: 134 · 2025: 263 · 2024: 294 · 2023: 276 · 2022: 171 · 2021: 53
FWCI: 13.60
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
www.elsevier.com/open-access/userlicense/1.0/ (vor, 372 d)
doi.org/10.15223/policy-017 (stm-asf)
doi.org/10.15223/policy-037 (stm-asf)
doi.org/10.15223/policy-012 (stm-asf)
doi.org/10.15223/policy-029 (stm-asf)
doi.org/10.15223/policy-004 (stm-asf)
Locations: Cancer Cell (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
Funders: Astellas Pharma US
National Cancer Institute (P30 CA023100)
Janssen Pharmaceuticals
AstraZeneca
Bristol-Myers Squibb
Genentech
Roche
EMD Serono
Pfizer
Meso Scale Diagnostics
Topics: Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer Genomics and Diagnostics
Keywords: tumor mutational burden, immunotherapy biomarkers, immune checkpoint inhibitors, neoantigens, MHC class I antigen presentation, T cell receptor repertoire, cancer immunotherapy response prediction
MeSH terms: Immune Checkpoint Inhibitors, Humans, Immunotherapy, Major Histocompatibility Complex, Mutation, Neoplasms, T-Lymphocytes, Biomarkers, Tumor

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The Challenges of Tumor Mutational Burden as an Immunotherapy Biomarker

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