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    Association details:
    Biomarker:TMB-H
    Cancer:Non Small Cell Lung Cancer
    Drug:Opdivo (nivolumab) (PD1 inhibitor) +
    Yervoy (ipilimumab) (CTLA4 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    ESMO.org
    Title:

    Pan-Asian adapted Clinical Practice Guidelines for the management of patients with metastatic non-small-cell lung cancer: a CSCO–ESMO initiative endorsed by JSMO, KSMO, MOS, SSO and TOS

    Published date:
    12/28/2018
    Excerpt:
    Nivolumab plus ipilimumab represents an option for the treatment of patients with NSCLC with a high TMB [I, A].
    DOI:
    10.1093/annonc/mdy554
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ELCC 2021
    Title:

    98O - First-line nivolumab (NIVO) + ipilimumab (IPI) + 2 cycles chemotherapy (chemo) vs 4 cycles chemo in advanced non-small cell lung cancer (aNSCLC): association of blood and tissue tumor mutational burden (TMB) with efficacy in CheckMate 9LA

    Published date:
    03/17/2021
    Excerpt:
    Higher TMB appeared to be associated with improved PFS and ORR benefits of NIVO + IPI + chemo over chemo.
    Secondary therapy:
    Chemotherapy
    Trial ID:
    CheckMate 9LA
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Eur J Cancer
    Title:

    Nivolumab plus ipilimumab versus chemotherapy as first-line treatment in advanced non-small-cell lung cancer with high tumour mutational burden: patient-reported outcomes results from the randomised, open-label, phase III CheckMate 227 trial

    Excerpt:
    First-line nivolumab + ipilimumab demonstrated early, sustained improvements in PROs versus chemotherapy in patients with advanced NSCLC and high TMB.
    DOI:
    10.1016/j.ejca.2019.05.008
    Trial ID:
    CheckMate 227
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    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: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers

    Excerpt:
    ...- High Tumor Mutation Burden...
    Trial ID:
    CHECKMATE 817
    More C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    N Engl J Med
    Title:

    Nivolumab plus Ipilimumab in Lung Cancer with a High Tumor Mutational Burden

    Excerpt:
    Progression-free survival was significantly longer with first-line nivolumab plus ipilimumab than with chemotherapy among patients with NSCLC and a high tumor mutational burden, irrespective of PD-L1 expression level.
    DOI:
    10.1056/NEJMoa1801946
    Trial ID:
    CheckMate 227