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    Association details:
    Biomarker:TMB-H
    Cancer:Gastric Cancer
    Drug:Keytruda (pembrolizumab) (PD1 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    NCCN
    Excerpt:
    Gastic Cancer: Useful in certain circumstances…Pembrolizumab for TMB high (≥10 mutations/megabase) tumors
    Evidence Level:
    Sensitive: C1 - Off-label
      (Approved for Solid Tumor)
    New
    Excerpt:
    KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated:...for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Exploratory Single-arm, Single-center Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer With Combination of Palizumab and SOX Regimen

    Excerpt:
    ...Consistent with high tumor mutation load TMB-H (≥10 mutations/megabases) 3....
    Trial ID:
    NCT06036745
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    AACR 2023
    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
    Source:
    ASCO 2021
    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
    Source:
    ESMO 2020
    Title:

    1442p - Association of TMB using the Foundation Medicine Companion Diagnostic (F1CDx) with efficacy of first-line pembrolizumab (pembro) or pembro plus chemotherapy (pembro + chemo) versus chemo in patients with gastric cancer (gc) from KEYNOTE-06

    Published date:
    09/14/2020
    Excerpt:
    This prespecified exploratory analysis from the randomized KEYNOTE-062 trial provides evidence of an association between TMB and clinical response with first-line pembro monotherapy and pembro + chemo but not with chemo in patients with GC. Data further suggest a survival benefit in pembro-treated patients with TMB ≥10 mut/Mb, which include a majority of patients with tumors with high microsatellite instability.
    Secondary therapy:
    Chemotherapy
    Trial ID:
    KEYNOTE-062
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ESMO 2020
    Title:

    1442p - Association of TMB using the Foundation Medicine Companion Diagnostic (F1CDx) with efficacy of first-line pembrolizumab (pembro) or pembro plus chemotherapy (pembro + chemo) versus chemo in patients with gastric cancer (gc) from KEYNOTE-06

    Published date:
    09/14/2020
    Excerpt:
    This prespecified exploratory analysis from the randomized KEYNOTE-062 trial provides evidence of an association between TMB and clinical response with first-line pembro monotherapy and pembro + chemo but not with chemo in patients with GC. Data further suggest a survival benefit in pembro-treated patients with TMB ≥10 mut/Mb, which include a majority of patients with tumors with high microsatellite instability.
    Trial ID:
    KEYNOTE-062