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    Association details:
    Biomarker:TMB-H
    Cancer:Gallbladder Cancer
    Drug:Keytruda (pembrolizumab) (PD1 inhibitor)
    Direction:Sensitive
    Evidence:
    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:

    Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)

    Excerpt:
    ...- Any advanced solid tumor that has failed at least one line of therapy and is TMB-H (≥10 mut/Mb, F1CDx assay), excluding dMMR/MSI-H tumors....
    Trial ID:
    KEYNOTE-158
    Evidence Level:
    Sensitive: C4 – Case Studies
    Source:
    Intern Med
    Title:

    Successful Treatment of Metastatic Gallbladder Carcinoma with a High Tumor Mutational Burden Using Pembrolizumab: A Case Report

    Published date:
    03/15/2023
    Excerpt:
    A woman in her 70s presented with gallbladder carcinoma with liver metastases and peritoneal dissemination….CDx analysis showed that the tumor mutational burden (TMB) was high (34 mutations/megabase). Treatment with pembrolizumab, which is an immune checkpoint inhibitor (ICI), resulted in a partial response...
    DOI:
    10.2169/internalmedicine.1610-23