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Association details:
Biomarker:TMB-H
Cancer:Gastric Cancer
Drug:Opdivo (nivolumab) (PD1 inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

4405 / 18 - Tumor mutational burden, as a potential predictive marker for the efficacy of immunotherapy in advanced gastric cancer

Published date:
03/15/2023
Excerpt:
...patients with AGC, who received pembrolizumab or nivolumab were included….The OS was longer in the TMB-high group with the median of 20.8 months (95% CI, 2.292-39.281) compared to the TMB-low group with the median of 3.31 months (95% CI, 1.604-5.019; p=0.049).
Evidence Level:
Sensitive: C3 – Early Trials
Title:

A multicenter, open-label, single-arm phase I trial of neoadjuvant nivolumab monotherapy for resectable gastric cancer

Published date:
03/07/2022
Excerpt:
The major pathologic response (MPR) assessed by the independent pathology review committee was achieved in five (16%) patients, of which one patient had a pathologic complete response. The MPR was mostly observed in patients with positive PD-L1 expression, high microsatellite instability, and/or high tumor mutation burden...Neoadjuvant nivolumab monotherapy is feasible with an acceptable safety profile and induces a MPR in certain patients with resectable GC.
DOI:
10.1007/s10120-022-01286-w
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

1419P - Insertion-deletion rate is a qualitative aspect of the tumor mutation burden associated with the clinical outcomes of gastric cancer patients treated with nivolumab

Published date:
09/13/2021
Excerpt:
A total of 105 patients with advanced gastric cancer who were treated with nivolumab...Patients with a high Indel rate (> 40%) had favorable PFS and OS compared to those with a lower Indel rate (≤ 40%) (P = 0.009 ad P = 0.007, respectively).
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Insertion–deletion rate is a qualitative aspect of the tumor mutation burden associated with the clinical outcomes of gastric cancer patients treated with nivolumab

Published date:
09/01/2021
Excerpt:
A total of 105 patients with advanced gastric cancer who were treated with nivolumab as third or later line of therapy were included as the study population….Patients with TMB > 18.03/Mb showed superior progression-free survival (PFS) and overall survival (OS) compared to those with TMB ≤ 18.03/Mb.
DOI:
10.1007/s10120-021-01233-1
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Matched therapies for advanced gastric cancer based on genotype: A real-world study in China.

Published date:
05/19/2021
Excerpt:
...6 (20%) dMMR/MSI-H/TMB-H (received sintilimab, pembrolizumab, tislelizumab or nivolumab, combined with antivascular or not, cohort C)...In cohort C, ORR was 17% (1/6), DCR was 67% (4/6), mPFS and mOS was 1.9 months and 6.8 months, respectively.
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:

Clinicopathological and molecular features of responders to nivolumab for patients with advanced gastric cancer

Excerpt:
ORR was 31% in pts with at least one of the following factors; MMR-D, high TMB, EBV+ and PD-L1+ in TC vs. 0% in those without these factors.
DOI:
10.1186/s40425-019-0514-3