^
    Back
    Association details:
    Biomarker:BRAF V600E
    Cancer:Non Small Cell Lung Cancer
    Drug:Mektovi (binimetinib) (MEK inhibitor) +
    Braftovi (encorafenib) (BRAF inhibitor, cRAF inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    FDA
    Published date:
    10/11/2023
    Excerpt:
    BRAFTOVIis a kinase inhibitor indicated:...in combination with binimetinib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.
    Test:
    FoundationOne® CDx, FoundationOne® Liquid CDx
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lung Cancer

    Excerpt:
    ...- Presence of a BRAFV600E mutation in lung cancer tissue as determined by a local laboratory assay or the presence of other BRAFV600 mutations other than V600E (i.e. K or D) will be considered...
    Trial ID:
    PHAROS
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrialsregister.eu
    Title:

    A study comparing combination of Encorafenib + Binimetinib in Patients with BRAF V600E-mutant Non-small Cell Lung Cancer. Estudio para evaluar la combinación de Encorafenib + Binimetinib en pacientes con cáncer de pulmón no microcítico con mutación BRAFV600E

    Excerpt:
    ...Presence of a BRAFV600E mutation in lung cancer tissue as determined by a local laboratory assay. ...
    Trial ID:
    2019-000417-37
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    J Clin Oncol
    Title:

    Phase II, Open-Label Study of Encorafenib Plus Binimetinib in Patients With BRAFV600-Mutant Metastatic Non-Small-Cell Lung Cancer

    Published date:
    06/04/2023
    Excerpt:
    ...98 patients (59 treatment-naïve and 39 previously treated) with BRAFV600E-mutant metastatic NSCLC received encorafenib plus binimetinib….ORR by IRR was 75% (95% CI, 62 to 85) in treatment-naïve and 46% (95% CI, 30 to 63) in previously treated patients; median DOR was not estimable (NE; 95% CI, 23.1 to NE) and 16.7 months (95% CI, 7.4 to NE), respectively. DCR after 24 weeks was 64% in treatment-naïve and 41% in previously treated patients. Median PFS was NE (95% CI, 15.7 to NE) in treatment-naïve and 9.3 months (95% CI, 6.2 to NE) in previously treated patients....For patients with treatment-naïve and previously treated BRAFV600E-mutant metastatic NSCLC, encorafenib plus binimetinib showed a meaningful clinical benefit...
    DOI:
    10.1200/JCO.23.00774
    Trial ID:
    PHAROS
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2023
    Title:

    Efficacy and safety of encorafenib (enco) plus binimetinib (bini) in patients with BRAF V600E-mutant (BRAFV600E) metastatic non-small cell lung cancer (NSCLC) from the phase 2 PHAROS study.

    Published date:
    05/25/2023
    Excerpt:
    The ORR (95% CI) by IRR was 75% (62, 85) in treatment-naive and 46% (30, 63) in previously treated pts….The combination of enco+bini showed meaningful clinical benefit in treatment-naive and previously treated pts with BRAFV600E metastatic NSCLC.
    DOI:
    10.1200/JCO.2023.41.16_suppl.9018
    Trial ID:
    PHAROS