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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Self-citation
Tumor Mutation Burden-Associated LINC00638/miR-4732-3p/ULBP1 Axis Promotes Immune Escape via PD-L1 in Hepatocellular Carcinoma
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“TMB corresponds to the number of somatic non-synonymous mutations per coding area of the tumoral DNA and is hypothesized to correlate with the production of a higher amount of neoantigens inducing a stronger immune response which can be exploited by ICIs [26].”
BackgroundInfluential
Association of KDR Mutation With Better Clinical Outcomes in Pan-Cancer for Immune Checkpoint InhibitorsPreprint
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“50 53 Although TMB alone is not sufficient to predict outcome, higher TMB scores have been associated with higher ICI efficacy in melanoma and non-small-cell lung cancer (NSCLC).”
Background
Multi-omic profiling reveals discrepant immunogenic properties and a unique tumor microenvironment among melanoma brain metastases
In, G. K., Ribeiro, J. R., Yin, J., Xiu, J., Bustos, M. A., Ito, F., Chow, F. E., Zada, G., Hwang, L., Salama, A. K. S., et al. (2023) · npj Precision Oncology · doi:10.1038/s41698-023-00471-z · Cited by 25
“…is related to neoantigen load and correlates with improved outcomes in several cancer types, but the absolute relationship between TMB and immunogenicity or response to immunotherapy may also depend upon the tumor type or the speci ﬁ c genomic landscape and immune repertoire of each patient 47 .”
Emerging Targets for Systemic Treatment of Gastric Cancer: HER2 and Beyond
Kim, I.-H. (2023) · Journal of the Korean Gastric Cancer Association · doi:10.5230/jgc.2024.24.e6 · Cited by 27
“TMB was initially identified through whole-exome sequencing, but because of its technical complexity and high cost, comprehensive gene panels using NGS have been used as substitutes in clinical settings [96].”
BackgroundMethod
Identification of Tumor Microenvironment and DNA Methylation-Related Prognostic Signature for Predicting Clinical Outcomes and Therapeutic Responses in Cervical Cancer
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A prognostic model for oral squamous cell carcinoma using 7 genes related to tumor mutational burden
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“And TMB levels are emerging as a novel prognostic biomarker for the response to immunotherapy in oncology clinic [21, 26, 27].”
Background
Photothermal Nanobomb Blocking Metabolic Adenosine-A2ar Potentiates Infiltration And Activity of T Cells for Robust Antitumor Immunotherapy
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“Thus, a higher TMB results in more tumor neoantigens, which increases chances for immunotherapy and is clinically associated with better ICB responses [46].”
Background
Pan-Cancer Analysis of the TRP Family, Especially TRPV4 and TRPC4, and Its Expression Correlated with Prognosis, Tumor Microenvironment, and Treatment Sensitivity
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“TMB can reflect the quantity of mutations in tumors and generate immunogenic neoantigens, which improves the possibility of T cell recognition, and clinically relates to better immune checkpoint inhibitors (ICIs) response (60).”
Background
Association of the CD4+/CD8+ ratio with response to PD-1 inhibitor-based combination therapy and dermatological toxicities in patients with advanced gastric and esophageal cancer
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“It is likely that only some non-synonymous mutations will lead to the generation of novel immunogenic peptides, and it may not be the burden of neo-antigens within a tumour, but the immunogenicity of the neo-antigen, which is vital in generating a strong anti-tumour immune response [76, 78].”
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Self-citation
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T-cell priming transcriptomic markers: implications of immunome heterogeneity for precision immunotherapy
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Proteomic and metabolomic features in patients with HCC responding to lenvatinib and anti-PD1 therapy
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Applications of Multimodal Artificial Intelligence in Non-Hodgkin Lymphoma B Cells
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“The tumor mutational burden (TMB) and the expression of the immune checkpoint PD-1 are primary biomarkers used to identify patients likely to respond to immunotherapy; however, their predictive power remains limited [80,81].”
Background
Artificial intelligence in predicting efficacy and toxicity of Immunotherapy: Applications, challenges, and future directions
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Comprehensive analysis of LAMC1 expression and prognostic value in kidney renal papillary cell carcinoma and clear cell carcinoma
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“Tumor mutational burden (TMB), as a quantifiable biomarker, can be used to reflect the number of mutations contained in a tumor cell, which was visualized with R software packages “ggstatsplot” (Jardim et al., 2021).”
Method
A novel prognostic index of stomach adenocarcinoma based on immunogenomic landscape analysis and immunotherapy options
Xue, W., Dong, B., Wang, Y., Xie, Y., Xue, Q., Gong, Z., Zhu, C., & Niu, Z. (2022) · Experimental and Molecular Pathology · doi:10.1016/j.yexmp.2022.104832 · Cited by 22
ORC6, a novel prognostic biomarker, correlates with T regulatory cell infiltration in prostate adenocarcinoma: a pan-cancer analysis
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“The TMB represents the number of somatic gene mutations existed in the cancer cells [28].”
Background
Prognostic role of IL-8 in cancer patients treated with immune checkpoint inhibitors: a system review and meta-analysis
Zou, D., Song, A., & Yong, W. (2023) · Frontiers in Oncology · doi:10.3389/fonc.2023.1176574 · Cited by 22
“TMB testing is not widely accessible or covered by insurance, potentially limiting patients’ access to these diagnostic tests (31).”
Background
Integrative analysis of cancer-associated fibroblast signature in gastric cancer
Zhao, Z., Mak, T. K., Shi, Y., Li, K., Huo, M., & Zhang, C. (2023) · Heliyon · doi:10.1016/j.heliyon.2023.e19217 · Cited by 22
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Microenvironmental regulation of tumour immunity and response to immunotherapy
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PD‐1/PD‐L1 inhibitors‐based treatment for advanced renal cell carcinoma: Mechanisms affecting efficacy and combination therapies
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Signatures of Multi-Omics Reveal Distinct Tumor Immune Microenvironment Contributing to Immunotherapy in Lung Adenocarcinoma
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“However, there are limitations for using TMB to identify potential patients; the response rate in patients with tumors that have TMB-H (≥20 mutations/Mb) is only 45% (59, 60).”
Background
The Characteristics of Tumor Microenvironment Predict Survival and Response to Immunotherapy in Adrenocortical Carcinomas
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Background
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“…neoantigen mutation burden (TMB) of individuals is directly related to the reactivity of NeoTCR-T cells [51], the heterogeneity of TMB emphasizes the importance of increasing the stability, affinity, and persistent functional activity of adoptively transferred NeoTCR-T cells in enhancing ACT [52].”
Background
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The Prognostic Value of ctDNA and bTMB on Immune Checkpoint Inhibitors in Human Cancer
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“However, there is currently no consensus over the optimal cut-off of TMB for patient stratification, leading to limited further application in the clinic (54).”

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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