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Updated: Oct 4, 2025
Predictive Immune Modeling of Solid Tumors
Published on: February 25, 2020
Tumor mutation burden predicts response and survival to immune checkpoint inhibitors: a meta-analysis
Linghong Wan1,2,3, Zhi Wang1,2,3, Jinmin Xue1,2,3
1Department of Oncology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Background:
Cancer is one of the world's top three causes of death now. Immune checkpoint inhibitors (ICIs) show encouraging ability to treat some malignancies due to its long-term efficacy and low side effects. However, the predictive biomarker of the immunotherapy efficacy has been inconclusive. Thus, exploring new biomarkers is important.
Methods:
A meta-analysis was conducted to evaluate whether tumor mutation burden (TMB) could be a predictive biomarker of the efficacy of ICIs. Using the PubMed and Cochrane Library databases, we searched for articles about TMB and the prognosis of patients with multiple malignancies conducted from 1984 to May 22, 2020. We identified the relationship between TMB and the clinical efficacy of ICIs by using Stata 12.1 software.
Results:
Eighteen articles with a total of 4,535 patients were included in this meta-analysis. Results showed that high-TMB patients had better progression-free survival (PFS) than low-TMB patients with cancer treated with ICIs (HR =0.45; 95% CI: 0.36-0.56, P=0.002). Moreover, high-TMB patients had longer overall survival (OS) than low-TMB patients. However, the heterogeneity was extremely high, so the result regarding OS was meaningless (HR =0.56; 95% CI: 0.44-0.70, P=0.000, I-squares: 72.6%).
Conclusions:
Our study indicates that high TMB is associated with better PFS. Thus, TMB can be considered as a predictive marker of PFS of patients treated with ICIs in the future.
Insights
High tumor mutation burden (TMB) is linked to better progression-free survival (PFS) in cancer patients receiving immune checkpoint inhibitors (ICIs). TMB shows promise as a biomarker for predicting treatment response to ICIs.
Area of Science:
- Oncology
- Immunotherapy
- Biomarker Discovery
Background:
- Cancer remains a leading cause of death globally.
- Immune checkpoint inhibitors (ICIs) offer effective cancer treatment with fewer side effects.
- Predictive biomarkers for ICI efficacy are needed to optimize treatment strategies.
Purpose of the Study:
- To evaluate tumor mutation burden (TMB) as a predictive biomarker for ICI therapy efficacy.
- To analyze the association between TMB and patient prognosis in various malignancies treated with ICIs.
Main Methods:
- A meta-analysis of 18 studies including 4,535 patients was performed.
- Literature search conducted on PubMed and Cochrane Library databases (up to May 22, 2020).
- Statistical analysis using Stata 12.1 to assess TMB's relationship with clinical efficacy.
Main Results:
- High TMB correlated with significantly better progression-free survival (PFS) in patients treated with ICIs (HR=0.45).
- High TMB was also associated with improved overall survival (OS), though this finding had high heterogeneity.
- The study identified a strong link between high TMB and positive clinical outcomes in ICI-treated cancers.
Conclusions:
- Tumor mutation burden (TMB) is a potential predictive biomarker for progression-free survival (PFS) in patients receiving immune checkpoint inhibitors (ICIs).
- Further research can validate TMB's role in predicting response to immunotherapy.
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