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Association details:
Biomarker:TMB-H
Cancer:Non Small Cell Lung Cancer
Drug:Opdivo (nivolumab) (PD1 inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: B - Late Trials
New
Source:
Title:

Abstract CT082: Impact of tumor mutation burden on the efficacy of first-line nivolumab in stage iv or recurrent non-small cell lung cancer: An exploratory analysis of CheckMate 026

Excerpt:
This is the first pivotal randomized phase 3 trial to incorporate an analysis evaluating TMB and clinical benefit with programmed death-1 inhibitor therapy. The findings of this exploratory retrospective analysis suggest that nivolumab improves ORR and PFS compared with platinum doublet chemotherapy in patients with high TMB.
DOI:
10.1158/1538-7445.AM2017-CT082
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Determinants of survival in advanced non-small cell lung cancer patients treated with anti-PD-1/PD-L1 therapy

Published date:
11/01/2021
Excerpt:
This observational retrospective study involved 73 patients with advanced NSCLC who received either anti-PD-1 (pembrolizumab, nivolumab, or camrelizumab) or anti-PD-L1 (atezolizumab) therapy….Our results showed that the variables of male sex, smoking history, and high TMB were associated with a significantly longer PFS....Patients with high TMB and low TMB had an mPFS of 3.7 and 2.1 months (log-rank P=0.004), respectively.... In univariate analysis of PFS, TMB was found to be a significant determinant of PFS (HR, 0.46; 95% CI, 0.23–0.92; P=0.027)....In multivariable analysis, TMB was identified as an independent determinant factor of PFS (HR, 0.41; 95% CI, 0.23–0.73; P=0.002)...
DOI:
10.21037/atm-21-1702
Evidence Level:
Sensitive: C3 – Early Trials
Title:

P60.07 - TMB and Selected Mutations in Resectable Stage IIIA NSCLC Patients Receiving Neo-Adjuvant Chemo-Immunotherapy from NADIM Trial

Published date:
01/12/2021
Excerpt:
...resectable stage IIIA NSCLC patients were treated with neoadjuvant chemo-immunotherapy with Nivolumab….PFS at 18 and 24 months was 100% (95% CI not estimable) for Non-mutated patients with TMB-High vs 70% (95% CI 50-89%) and 58% (95% CI 35-81%) for the rest of patients (mutated patients plus Non-mutated patients with TMB-Low).
Trial ID:
Evidence Level:
Sensitive: C4 – Case Studies
Title:

Relationship of hypothyroidism and immune response to pegylated IL-10/nivolumab

Published date:
08/18/2020
Excerpt:
We describe a case of an advanced disease non-small-cell lung cancer patient with low PD-L1 expression, but high tumor mutation burden (35 muts/Mb) who developed immune-related hypothyroidism and achieved subsequent partial response...with nivolumab and PEGylated IL-10...Results suggest positive antitumor activity to combination IL-10/nivolumab despite low PD-L1 expression but in likely relationship to high tumor mutation burden and in association with immune-mediated thyroid dysfunction in this case.
Secondary therapy:
LY3500518
DOI:
10.2217/imt-2020-0016
Trial ID: