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    Association details:
    Biomarker:TMB-H
    Cancer:Melanoma
    Drug:Opdivo (nivolumab) (PD1 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ASCO 2023
    Title:

    Association of biomarkers (BMs) with efficacy of adjuvant nivolumab (NIVO) vs placebo (PBO) in patients with resected stage IIB/C melanoma (CA209-76K).

    Published date:
    05/25/2023
    Excerpt:
    ...efficacy of adjuvant nivolumab (NIVO) vs placebo (PBO) in patients with resected stage IIB/C melanoma...Higher IFNγ-sig, TMB, and % CD8+ T cells, and lower CRP levels were associated with longer RFS with NIVO treatment.
    DOI:
    10.1200/JCO.2023.41.16_suppl.9504
    Trial ID:
    CheckMate76K
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ESMO 2019
    Title:

    1310O - Adjuvant nivolumab (NIVO) versus ipilimumab (IPI) in resected stage III/IV melanoma: 3-year efficacy and biomarker results from the phase III CheckMate 238 trial

    Published date:
    09/28/2019
    Excerpt:
    High levels of all biomarkers analyzed (interferon-gamma gene expression signature, tumor mutational burden, and CD8+ T-cell infiltration by immunohistochemistry) showed an association with improved RFS for both NIVO and IPI.
    Trial ID:
    CheckMate 238
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Sci Rep
    Title:

    Next-generation sequencing in advanced Chinese melanoma reveals therapeutic targets and prognostic biomarkers for immunotherapy

    Published date:
    06/10/2022
    Excerpt:
    Among 81 patients enrolled, 25 of them received palliative immunotherapy including anti-PD-1 antibody (pembrolizumab or nivolumab), anti-CTLA4 antibody (ipilimumab) monotherapy or combinations….Patients with TMB > 15 mut/Mb had a significantly longer PFS than patients with TMB ≤ 15 mut/Mb (p = 0.049) (Fig. 4b). High TMB was associated with improved PFS.
    DOI:
    10.6084/m9.figshare.19115486.
    Evidence Level:
    Sensitive: C3 – Early Trials
    New
    Source:
    Cancer Immunol Res
    Title:

    Targeted next generation sequencing identifies markers of response to PD-1 blockade

    Excerpt:
    Response rate, progression-free survival, and overall survival was superior in the high, compared to intermediate and low, mutation load groups....Patients had metastatic melanoma and began anti–PD-1 (nivolumab or pembrolizumab) or anti–PD-L1 (atezolizumab) between January 2011 and March 2015...
    DOI:
    10.1158/2326-6066.CIR-16-0143