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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Liu, X., & Ou, J. (2024) · Heliyon · doi:10.1016/j.heliyon.2024.e26013 · Cited by 6
“A higher TMB increases self-neoantigens and immunogenic recognition, enhancing the likelihood of T cell recognition, facilitating T cell responses against tumor cells, and indicating improved outcomes with ICI [23].”
Background
Identification and validation of a pyroptosis-related prognostic model for colorectal cancer based on bulk and single-cell RNA sequencing data
Li-hua, Z., Yang, J. J. J., Zhang, Y., Li, Y., Lin, W.-R., & Liu, W. (2024) · World Journal of Clinical Oncology · doi:10.5306/wjco.v15.i2.329 · Cited by 6
LAG-3 transcriptomic expression correlates linearly with other checkpoints, but not with clinical outcomes
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TM-Score predicts immunotherapy efficacy and improves the performance of the machine learning prognostic model in gastric cancer
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Cancer-associated fibroblast-derived gene signature discriminates distinct prognoses by integrated single-cell and bulk RNA-seq analyses in breast cancer.
Zhou, F., Han, Y.-L., Gao, Z., & Feng, Y. (2024) · PubMed Central · doi:10.18632/aging.205817 · Cited by 6
“Additionally, as an indicator of tumor mutations, TMB is frequently used to predict the efficacy of immunotherapy [30].”
Background
Enhanced Antitumor Response to Immune Checkpoint Blockade Exerted by Cisplatin-Induced Mutagenesis in a Murine Melanoma Model
Gorgun, F. M., Widen, S. G., Tyler, D. S., & Englander, E. W. (2021) · Frontiers in Oncology · doi:10.3389/fonc.2021.701968 · Cited by 6
Comprehensive analysis of FRAS1/FREM family as potential biomarkers and therapeutic targets in renal clear cell carcinoma
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“TMB is a potential pan-cancer predictive biomarker of immune checkpoint inhibitor response in most cancers (Jardim et al., 2021).”
Background
Characterization of genomic alterations and neoantigens and analysis of immune infiltration identified therapeutic and prognostic biomarkers in adenocarcinoma at the gastroesophageal junction
Lao, Y., Wang, Y., Yang, J., Liu, T., Ma, Y., Luo, Y., Sun, Y., Li, K., Zhao, X., Niu, X., et al. (2022) · Frontiers in Oncology · doi:10.3389/fonc.2022.941868 · Cited by 6
“As shown in Figure 3D, higher TMB was significantly associated with higher intratumor heterogeneity (P 0.05).”
BackgroundInfluential
Rheumatic complications of checkpoint inhibitors: Lessons from autoimmunity
Reynolds, G. (2023) · Immunological Reviews · doi:10.1111/imr.13242 · Cited by 13
Integrating multiple machine learning algorithms for prognostic prediction of gastric cancer based on immune-related lncRNAs
Li, G., Huo, D., Guo, N., Li, Y., Ma, H., Liu, L., Xie, H., Zhang, D., Qu, B., & Chen, X. (2023) · Frontiers in Genetics · doi:10.3389/fgene.2023.1106724 · Cited by 5
“However, the frequency of mutations was lower in high-risk patients, and in general, the frequency of mutations was higher in patients with poor prognoses, suggesting that our classification is not suitable for studies that predict immunotherapy response based on tumor mutational burden (TMB) (Jardim et al., 2021).”
BackgroundInfluential
Transcriptional Phenocopies of Deleterious KEAP1 Mutations Correlate with Survival Outcomes in Lung Cancer Treated with Immunotherapy
Scalera, S., Ricciuti, B., Marinelli, D., Mazzotta, M., Cipriani, L., Bon, G., Schiavoni, G., Terrenato, I., Federico, A. D., Alessi, J. V., et al. (2024) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-24-0626 · Cited by 5
Photonanozyme–Kras–ribosome combination treatment of non-small cell lung cancer after COVID-19
Si, Q., Bai, M., Wang, X., Wang, T., & Qin, Y. (2024) · Frontiers in Immunology · doi:10.3389/fimmu.2024.1420463 · Cited by 5
“Factors such as tumor PD-L1 expression, tumor mutational burden, and the presence of other immune cells in the tumor microenvironment can in ﬂ uence the ef ﬁ cacy of PD-1/PD-L1 inhibitors (115).”
Background
Unveiling the role of PANoptosis-related genes in breast cancer: an integrated study by multi-omics analysis and machine learning algorithms
Liu, G., Pan, L.-Z., Chen, J., & Ma, J. (2025) · Breast Cancer Research and Treatment · doi:10.1007/s10549-025-07620-x · Cited by 5
“This is particularly relevant as high TMB has been associated with increased neoantigen load, potentially enhancing the efficacy of immunotherapies [24, 25].”
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Chen, Z., Hu, B., Cai, K., Gao, H., Xian, Z., Zhang, S., Fang, Z., Zhou, Q., Ren, D., & Zou, Q. (2025) · Cancer Immunology Immunotherapy · doi:10.1007/s00262-025-04027-x · Cited by 6
Durvalumab with or without tremelimumab in combination with chemotherapy in first-line metastatic non-small-cell lung cancer: outcomes by tumor mutational burden in POSEIDON
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“This was in line with expectations from mechanistic studies, which have indicated that higher TMB is correlated with more tumor neoantigens, 12,14 and previous clinical trials of regimens combining tremelimumab and durvalu-mab in ﬁ rst-line treatment of patients with mNSCLC. 6,9 28-30 Patients with…”
Subclassification-Specific Tumor Immune Microenvironment in Intrahepatic Cholangiocarcinoma: Implications for Appropriate Pharmacotherapy
Kinoshita, M., Sato, Y., Kubo, S., Shinkawa, H., Kimura, K., Nishio, K., Tanaka, R., Kurihara, S., & Ishizawa, T. (2025) · Cancers · doi:10.3390/cancers17132082 · Cited by 5
“Tumor antigen release is caused by various mechanisms, and the tumor mutation burden (TMB) has one of the most representative roles [29,30].”
Thymidine phosphorylase associates with DNA damage repair to facilitate stemness maintenance, chemoresistance, and immunosuppression in pan-cancer
Liao, P., Han, Z., Yan, B., Chen, F., & Lei, P. (2025) · International Journal of Biological Macromolecules · doi:10.1016/j.ijbiomac.2025.145707 · Cited by 5
Chemoimmunomodulation in triple negative breast cancer: a key to maximizing anti-PD-1 chemoimmunotherapeutic efficacy
Gbadamosi, M. O., Molchan, E., Makarem, M. S., Coleman, K. L., Ohaegbulam, A., & Streeks, K. H. (2025) · OncoImmunology · doi:10.1080/2162402x.2025.2527303 · Cited by 6
“187,188 Nevertheless, there are some data pointing to utility in TNBC. Specifically, in the KEYNOTE-119 study, increased TMB was associated with response to pembrolizumab as a single agent, but not chemotherapy in patients with mTNBC. 189”
The potential of antibody-drug conjugates in immunotherapy for non-small cell lung cancer: current progress and future
Lin, H., Ma, X., Zhu, X., & Zhong, L. (2025) · Frontiers in Oncology · doi:10.3389/fonc.2025.1630056 · Cited by 6
“Conversely, tumors with low TMB are often associated with a diminished or suboptimal therapeutic response to these treatments (89).”
Unraveling the molecular-pathological characteristics and cellular complexity of the tumor immune microenvironment in metastatic non-small cell lung cancer
Bharadwaj, S., Mierzwicka, J. M., Vaňková, L., & Malý, P. (2025) · Cell Communication and Signaling · doi:10.1186/s12964-025-02410-w · Cited by 7
Long-term Survival and Molecular Biomarker Evaluation of a Phase II Cetuximab and Nivolumab Clinical Trial in Recurrent/Metastatic Head and Neck Cancer
Chaudhary, R., Moorhead, G., Park, R., Li, J., Schell, M. J., Song, X., Tan, A. C., Slebos, R. J. C., Biernacki, M. I., Freeman, S. S., et al. (2025) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-25-2201 · Cited by 5
From prediction to precision: Biomarker discovery and predictive modeling for personalized immune checkpoint blockade therapy
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Spatial heterogeneity of T cell repertoire across NSCLC tumors, tumor edges, adjacent and distant lung tissues
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“Tumor mutational burden (TMB) is another biomarker associated with efficacious responses to ICB and adoptive transfer of expanded autologous CD8 + T cells 8,9 .”
Background
How Do Molecular Classifications Affect the Neoadjuvant Treatment of Muscle-Invasive Urothelial Carcinoma?
Conci, N., Tassinari, E., Tateo, V., Rosellini, M., Marchetti, A., Ricci, C., Chessa, F., Santoni, M., Grande, E., Mollica, V., et al. (2023) · Molecular Diagnosis & Therapy · doi:10.1007/s40291-023-00679-6 · Cited by 5
“Moreover, a high somatic mutation rate with a median of 5.5 per megabase was reported, similar to that of non-small cell lung cancer and melanoma, hypothetically predicting a better efficacy of immune checkpoint inhibitors [28].”
Influential
Tumor Mutational Burden as a Biomarker of Immunotherapy Response: An Immunogram Approach in Onco-immunology
Ansari, A. I., Ray, S. K., Sharma, M., Rawal, R., & Singh, P. (2023) · Current Molecular Medicine · doi:10.2174/0115665240266906231024111920 · Cited by 5
Establish a novel tumor budding-related signature to predict prognosis and guide clinical therapy in colorectal cancer
Li, Q., Liu, G., Qiu, Q., Zhang, J., Li, R., Zhao, J., She, J., & Chen, Y. (2024) · Scientific Reports · doi:10.1038/s41598-024-52596-1 · Cited by 5
“Accumulative evidence shows that patients with a high TMB may benefit from immune checkpoint inhibitors (ICIs) 17 .”
Prognostic and immune predictive roles of a novel tricarboxylic acid cycle-based model in hepatocellular carcinoma
Zeng, Y., Yu, T., Jiang, S., Wang, J., Chen, L., Lou, Z., Pan, L., Zhang, Y., & Ruan, B. (2024) · Scientific Reports · doi:10.1038/s41598-024-52632-0 · Cited by 5
Endoplasmic reticulum stress regulators exhibit different prognostic, therapeutic and immune landscapes in pancreatic adenocarcinoma
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“58 Chen et al. 59 reported that camrelizumab response was not correlated with TMB.”
Bioinformatic analysis and experimental validation of cuproptosis-related LncRNA as a novel biomarker for prognosis and immunotherapy of oral squamous cell carcinoma
Liang, S., Ji, L., Yu, Z., Cheng, Y.-H., Gao, R., Yan, W., & Zhang, F. (2024) · Hereditas · doi:10.1186/s41065-024-00311-5 · Cited by 5
“TMB, which is the total number of somatic mutations per megabase (Mb) in the tumor genome, relates to the emergence of neoantigens triggering tumor immunity [31].”
Background
Transcriptomic analysis of GITR and GITR ligand reveals cancer immune heterogeneity with implications for GITR targeting
Moussa, P. (2024) · American Journal of Cancer Research · doi:10.62347/eced5481 · Cited by 6
MIS18A upregulation promotes cell viability, migration and tumor immune evasion in lung adenocarcinoma
Zhu, Y., Li, Z., Wu, Z., Zhuo, T., Dai, L., Liang, G., Peng, H., Lu, H., & Wang, Y. (2024) · Oncology Letters · doi:10.3892/ol.2024.14509 · Cited by 5
Case report: Splenic inflammatory pseudotumor-like follicular dendritic cell sarcoma (IPT-like FDCS): a trial of immunotherapy and review of the literature
Resnick, K., Monroe, C. R., Siddiqi, I. N., & Tam, E. L. (2024) · Frontiers in Oncology · doi:10.3389/fonc.2024.1360726 · Cited by 5
Pan-cancer analysis of ADAR1 with its prognostic relevance in low-grade glioma
Yang, Q., & Li, X. (2024) · Immunobiology · doi:10.1016/j.imbio.2024.152855 · Cited by 5
Comprehensive Analysis of NADH :Ubiquinone Oxidoreductase Subunit B3 in Gynecological Tumors and Identification of Its Natural Inhibitor Wedelolactone
Li, H., Jin, Y., Zhang, Y., Xie, X., & Li, N. (2024) · Chemical Biology & Drug Design · doi:10.1111/cbdd.70006 · Cited by 5
Role of CALCR expression in liver cancer: Implications for the immunotherapy response
Wang, S., Wang, W., & Zeng, J. (2024) · Molecular Medicine Reports · doi:10.3892/mmr.2024.13406 · Cited by 6
“Additionally, the associations between CALCR expression and genomic heterogeneity features, including the tumor mutational burden (TMB), microsatellite instability (MSI), neoantigen load (NEO) and homologous recombination deficiency (HRD) were investigated across multiple types of cancer, with a particular focus on LI…”
18 F-FDG PET/CT Predicts the Prognosis of Patients with Hepatocellular Carcinoma Undergoing Liver Transplantation
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“Additionally, the positive correlation between the T SUVmax /L SUVmax and TMB is noteworthy because a higher TMB has been linked to improved responses to immune checkpoint inhibitors (ICIs) in several cancer types [67].”
Integrated Multiomics Analysis and Machine Learning Approaches in Bladder Cancer: Unveiling the Impact of Immunogenic Cell Death and Its Key Gene SLC2A3 on Prognosis and Personalized Treatment Strategies
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The Effect of Tumor Mutation Burden on Immune Checkpoint Inhibitors in Non-Small Cell Lung Cancer: A Systematic Review and Comprehensive Meta-Analysis
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Genomic mapping of copy number variations influencing immune response in breast cancer
López-Cade, I., García‐Barberán, V., Morafraile, E. C., Díaz‐Tejeiro, C., Sáiz-Ladera, C., Sanvicente, A., Segura, P. P., Pandiella, A., Győrffy, B., & Ocaña, A. (2022) · Frontiers in Oncology · doi:10.3389/fonc.2022.975437 · Cited by 6
“Beyond the mere presence of a higher mutational load or genomic instability that leads to a higher presence of neo-epitopes and therefore a more immune infiltrate microenvironment (60), a global analysis of copy number variations in relation to immune populations has not been explored.”
Background
Cuproptosis-related gene signatures for predicting prognosis of lung adenocarcinoma
Ye, W., Huang, Y., & Li, X. (2022) · Medicine · doi:10.1097/md.0000000000030446 · Cited by 5
“[21] However, its use in LC has not been extensively extrapolated.”
27-gene Immuno-Oncology (IO) Score is Associated With Efficacy of Checkpoint Immunotherapy in Advanced NSCLC: A Retrospective BC Cancer Study
Saltman, D. L., Varga, M. G., Nielsen, T. J., Croteau, N. S., Lockyer, H. M., Jain, A., Vidal, G. A., Hout, D. R., Schweitzer, B. L., Seitz, R. S., et al. (2022) · Clinical Lung Cancer · doi:10.1016/j.cllc.2022.11.009 · Cited by 5
A prognostic model and immune regulation analysis of uterine corpus endometrial carcinoma based on cellular senescence
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“Studies have demonstrated that TMB can serve as an important component of composite predictors to guide tumor immunotherapy (26).”
Background
A circadian rhythm-related gene signature for prognosis, invasion and immune microenvironment of breast cancer
Wang, M., Liu, X., Wang, Q., & Zhang, H. (2023) · Frontiers in Genetics · doi:10.3389/fgene.2022.1104338 · Cited by 5
“The mechanism of ICIs for cancer treatment is primarily to reactivate T-lymphocytes and boost the body’s immune system, resulting in anti-tumor activity (Jardim et al., 2021).”
Background
PTPRD mutation is a prognostic biomarker for sensitivity to ICIs treatment in advanced non-small cell lung cancer
Ren, Z., Wang, L., & Leng, C. (2023) · Aging · doi:10.18632/aging.204964 · Cited by 5

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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