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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
    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
    New
    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
    New
    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
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Nivolumab in Combination With Ipilimumab (Part 1); Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer

    Excerpt:
    ...High TMB = ≥ 10 mutations per megabase Low TMB = < 10 mutations per megabase`Objective response rate (ORR) by tumor mutational burden (TMB) using DNA derived from tumor specimens was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment. ...
    Trial ID:
    CheckMate 568
    More C2 evidence
    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
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    New
    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