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    Association details:
    Biomarker:KRAS mutation
    Cancer:Non Small Cell Lung Cancer
    Drug:Keytruda (pembrolizumab) (PD1 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ESMO-IO 2019
    Title:

    LBA4 - Association of KRAS mutational status with response to pembrolizumab monotherapy given as first-line therapy for PD-L1-positive advanced nonsquamous NSCLC in KEYNOTE-042

    Published date:
    12/12/2019
    Excerpt:
    Outcomes of pembrolizumab and of chemotherapy for pts with and without KRAS mutation and for KRAS G12C carriers are in the Table. Of note, CIs were wide given the modest frequency of KRAS mutation and low frequency of KRAS G12C...These findings also suggest that a pembrolizumab-containing regimen is a clinically relevant comparator for studies of KRAS -targeted therapy given as first-line treatment of NSCLC.
    Trial ID:
    KEYNOTE-042
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Genetic Predictors of Benefit to Pembrolizumab

    Excerpt:
    ...- Chemotherapy naïve NSCLC patients.For NSCLC patients with lung adenocarcinoma, tumors must be Epidermal Growth Factor Receptor (EGFR) and Anaplastic Lymphoma Kinase (ALK) wild-type; if a Kirsten Ras (KRAS) mutation is detected, EGFR and ALK testing is...
    Trial ID:
    NCT02710396
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001)

    Excerpt:
    ...Objective Response Rate (ORR)`Mutant KRAS Specific T cells...
    Trial ID:
    V941-001
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ELCC 2023
    Title:

    66P - Outcome predictors for Pembrolizumab alone or with chemotherapy in advanced non-small cell lung cancer (NSCLC)

    Published date:
    03/23/2023
    Excerpt:
    Among patients harboring any KRAS mutations, we observed an advantage of Pembro-CT over Pembro in terms of PFS (p = 0.02), with a trend of benefit in OS….While no significant differences were found in OS, some patients, notably those harboring KRAS alterations, may benefit from the addition of chemotherapy.
    Secondary therapy:
    Chemotherapy
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ELCC 2022
    Title:

    Pembrolizumab versus best supportive care survival outcomes in ECOG performance status 2 NSCLC patients

    Published date:
    03/23/2022
    Excerpt:
    ...the median OS was 21 vs 2 months with Pembro and BSC (p<0.01) and was consistently better in Pembro patients among KRAS mutant patients...
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    medRxiv
    Title:

    KRAS mutations impact clinical outcome in metastatic non-small cell lung cancer

    Published date:
    02/14/2022
    Excerpt:
    KRAS mutations is a positive predictive factor for treatment with pembrolizumab and a negative predictive factor for platinum doublet chemotherapy as well as general OS in stage IV NSCLC.
    DOI:
    10.1101/2021.11.27.21266822v2
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2021
    Title:

    First-line pembrolizumab monotherapy for PD-L1-positive (TPS = 50%) advanced non-small cell lung cancer (aNSCLC) in the real world: A national French bispective multicentric cohort—ESCKEYP trial (GFPC 05-2018).

    Published date:
    05/19/2021
    Excerpt:
    Bispective, national and multicentric study including consecutively aNSCLC patients who initiated first-line pembrolizumab monotherapy...KRAS mutated: 27.7%, PDL1 TPS > 75%: 53.7%...With a median follow up of 25,8 [95%CI: 24,8-26,7] months, median rwPFS and median OS were 8,2 [95%CI: 6,9-9,5] and 22,6 [95%CI: 18,5-27,4] months, respectively; 6, 12, 18-months survival rates were 76,8%, 64,8% and 54,3%....
    DOI:
    10.1200/JCO.2021.39.15_suppl.9091
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    SITC 2020
    Title:

    Complex markers of survival from pembrolizumab: the potential predictive role of tumor mutational burden (TMB) and KRAS

    Published date:
    11/09/2020
    Excerpt:
    We identified a cohort of metastatic EGFR/ALK wild type NSCLC patients...KRAS mutant status was independently significant for OS benefit from pembrolizumab + chemotherapy [HR=0.01; CI=0.01–0.79; p=0.04] but not for pembrolizumab monotherapy or chemotherapy alone.
    Secondary therapy:
    Chemotherapy
    Evidence Level:
    Sensitive: C3 – Early Trials
    New
    Source:
    Clin Cancer Res
    Title:

    Potential Predictive Value of TP53 and KRAS Mutation Status for Response to PD-1 Blockade Immunotherapy in Lung Adenocarcinoma

    Excerpt:
    To further confirm these observations from a public database, we prospectively collected 20 NSCLC (15 ADC) patients who were treated with pembrolizumab (n = 11) or nivolumab (n = 9) from August 2015 to August 2016 in our center (GLCI)….Patients with TP53 and/or KRAS mutation showed prolonged PFS than both genes negative patients treated with PD-1 inhibitors.
    DOI:
    10.1158/1078-0432.CCR-16-2554
    Trial ID:
    KEYNOTE-001