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Updated: Oct 4, 2025
Predictive Immune Modeling of Solid Tumors
Published on: February 25, 2020
Predictive value of tumor mutational burden for immunotherapy in non-small cell lung cancer: A systematic review and
Guangxian Meng1, Xiaowei Liu1, Tian Ma1
1Department of Thoracic surgery, The Second Hospital of Dalian Medical University, Dalian, Liaoning Province, China.
Background:
Immunotherapy has emerged as a promising treatment for non-small cell lung cancer (NSCLC). Yet, some patients cannot benefit from immunotherapy, and reliable biomarkers for selecting sensitive patients are needed. Herein, we performed a meta-analysis to evaluate the predictive value of tumor mutational burden (TMB) in NSCLC patients treated with immunotherapy.
Methods:
Eligible studies were comprehensively searched from electronic databases prior to August 31, 2021. Meta-analyses of high TMB versus low TMB as well as immunotherapy versus chemotherapy in patients with high/low TMB were conducted. Hazard ratio (HR) with corresponding 95% confidence interval (95%CI) for progression-free survival (PFS) and overall survival (OS) and odds ratio (OR) with 95%CI for objective response rate (ORR) were calculated.
Results:
A total of 31 datasets (3437 patients) and 6 randomized controlled trials (3662 patients) were available for meta-analyses of high TMB versus low TMB and immunotherapy versus chemotherapy, respectively. High TMB predicted significantly favorable PFS (HR = 0.54, 95%CI: 0.46-0.63, P<0.001) and OS (HR = 0.70, 95%CI: 0.57-0.87, P = 0.001), and higher ORR (OR = 3.14, 95%CI: 2.28-4.34, P<0.001) compared with low TMB. In patients with high TMB, immunotherapy was associated with improved PFS (HR = 0.62, 95%CI: 0.53-0.72), OS (HR = 0.67, 95%CI: 0.57-0.79) and ORR (OR = 2.35, 95%CI: 1.74-3.18) when compared with chemotherapy. However, in patients with low TMB, immunotherapy seemed to predict inferior PFS (HR = 1.20, 95%CI: 1.02-1.41) and ORR (OR = 0.61, 95%CI: 0.44-0.84) and have no OS benefit (HR = 0.88, 95%CI: 0.74-1.05) as compared with chemotherapy.
Conclusion:
This meta-analysis demonstrates more clinical benefits concerning treatment response and survival outcomes in high-TMB NSCLC patients who are treated with immunotherapy. TMB is a promising biomarker for discriminating NSCLC patients who can benefit more from immunotherapy.
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