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Association details:
Biomarker:TMB-H
Cancer:Solid Tumor
Drug Class:Immunotherapy
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: B - Late Trials
Title:

The predictive efficacy of tumor mutation burden in immunotherapy across multiple cancer types: A meta-analysis and bioinformatics analysis

Published date:
03/23/2022
Excerpt:
Compared with low TMB patients receiving ICIs, high TMB yielded a better ORR (RR = 2.73; 95% CI: 2.31-3.22; P = 0.043) and DCB (RR = 1.93; 95% CI: 1.64-2.28; P = 0.356), and a significantly increased OS (HR =0.24; 95% CI: 0.21-0.28; P < 0.001) and PFS (HR = 0.38; 95% CI: 0.34-0.42; P < 0.001)....TMB is a promising therapeutic and prognostic biomarker for immunotherapy, which indicates a better ORR, DCB, OS and PFS.
DOI:
10.1016/j.tranon.2022.101375
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

371 - A single-center retrospective review assessing the use of tumor mutation burden as a predictor of therapeutic success in patients receiving immunotherapy

Published date:
03/10/2021
Excerpt:
A total of 34 patients met the inclusion criteria of having a high TMB value (10 mutations/megabase) and having received one dose of pembrolizumab, ipilimumab, or nivolumab....16 patients experienced a partial response (AR = 0.47) and 6 of these patients experienced a complete response (AR = 0.17)...KEYNOTE-158 found a significant correlation between high TMB and improved clinical outcomes in patients receiving checkpoint inhibitors.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Predictors of response to immune checkpoint inhibitor therapy in metastatic solid tumors: real world evidence

Published date:
11/09/2020
Excerpt:
A statistically significant improvement in PFS was observed in the PIK3 mutated cohort (median 123 vs. 23 weeks...PIK3 mutants had a higher overall response rate (ORR) than the wild type (69.6% vs. 43.5%, OR 0.34; p=0.045; tables 3 and 4)….Median PFS was higher in the high TMB cohort compared to the low-intermediate group and reached statistical significance (median not reached vs. 26 weeks; HR=0.37. 95%CI 0.13, 1.05)...PFS improvement in patients with tumors expressing PDL1 trended towards statistical significance (median 18 vs. 40 weeks. HR=1.43. 95%CI 0.93, 4.46). BRAF mutation conferred shorter PFS (median 17 vs. 39 weeks. HR=0.35. 95%CI 0.14, 0.91) (figure 2).
DOI:
10.1136/jitc-2020-SITC2020.0053
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Clinical usefulness of Tumor Mutational Burden (TMB) assessed by NGS in solid tumors

Published date:
10/09/2020
Excerpt:
Patients with TMB-high had better durable response to ICB than TMB-low patients (p = 0.004). Objective response rate was 75% (9 out of 12) in TMB-high on the other hand 25% (10 out of 40) in TMB-low group….We confirmed the usefulness of TMB as an immunotherapy biomarker in solid tumors.