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    Association details:
    Biomarker:TMB-H
    Cancer:Small Cell Lung Cancer
    Drug:Opdivo (nivolumab) (PD1 inhibitor) +
    Yervoy (ipilimumab) (CTLA4 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    J Clin Oncol
    Title:

    Nivolumab and Ipilimumab as Maintenance Therapy in Extensive-Disease Small-Cell Lung Cancer: CheckMate 451

    Published date:
    03/08/2021
    Excerpt:
    CheckMate 451, a double-blind phase III trial, evaluated nivolumab plus ipilimumab and nivolumab monotherapy as maintenance therapy following first-line chemotherapy for ED-SCLC....In the TMB-evaluable population, OS was improved with combination therapy versus placebo in patients with TMB ≥13 mut/Mb (HR, 0.61; 95% CI, 0.39 to 0.94; Fig 3A) but not in those with TMB<13 mut/Mb (HR, 1.04; 95% CI, 0.79 to 1.37; Fig 3B).
    DOI:
    10.1200/JCO.20.02212
    Trial ID:
    CheckMate 451
    Test:
    FoundationOne® CDx
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    BIOLUMA: Biomarkers for Nivolumab and Ipilimumab and Evaluation of the Combination in Lung Cancer

    Excerpt:
    ...Only patients with high Tumor Mutation Burden are eligible....
    Trial ID:
    BIOLUMA
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Cancer Cell
    Title:

    Tumor Mutation Burden and Efficacy of Nivolumab Monotherapy and in Combination With Ipilimumab in Small Cell Lung Cancer

    Published date:
    05/14/2018
    Excerpt:
    Efficacy of nivolumab ± ipilimumab was enhanced in patients with high tumor mutational burden. Nivolumab plus ipilimumab appeared to provide a greater clinical benefit than nivolumab monotherapy in the high tumor mutational burden tertile.
    DOI:
    10.1016/j.ccell.2018.04.001
    Trial ID:
    CheckMate 032