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BackgroundImmunotherapy 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.MethodsEligible 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.ResultsA 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, PConclusionThis 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.