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    Association details:
    Biomarker:BRAF V600E
    Cancer:Colorectal Cancer
    Drug:Mektovi (binimetinib) (MEK inhibitor) +
    Braftovi (encorafenib) (BRAF inhibitor, cRAF inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    New
    Source:
    PipelineReview
    Title:

    Pierre Fabre receives positive CHMP opinion for BRAFTOVI® (encorafenib) in combination with cetuximab for the treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer

    Published date:
    05/01/2020
    Excerpt:
    BRAFTOVI in combination with cetuximab significantly improved overall survival (OS) in patients with BRAFV600E-mutant mCRC (median 9.3 months vs 5.9 months) and reduced the risk of death by 40%, compared with the cetuximab plus irinotecan-containing regimen (control) arm. Furthermore, the combination reported an improved objective response rate (ORR) (20% vs 2%, p<0.0001, per assessment by blinded independent central review [BICR]), compared with the control arm...
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    European Medicines Agency
    Published date:
    04/30/2020
    Excerpt:
    On 30 April 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Braftovi....in combination with binimetinib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation....in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior systemic therapy.
    Evidence Level:
    Sensitive: C1 - Off-label
      (Approved for Melanoma)
    Excerpt:
    BRAFTOVI is a kinase inhibitor indicated, in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrialsregister.eu
    Title:

    International multicenter study to test the use of 3 combined targeted therapy drugs for Colorectal cancer (encorafenib, binimetinib and cetuximab) in subjects with mutant Metastatic Colorectal Cancer

    Excerpt:
    ...Presence of BRAFV600E mutation in tumor tissue previously determined by a local assay at any time prior to screening.Notes:a. ...
    Trial ID:
    2018-000271-32
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer

    Excerpt:
    ...- Presence of BRAFV600E in tumor tissue as previously determined by a local assay at any time prior to Screening or by the central laboratory...
    Trial ID:
    BEACON CRC
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    A Phase Ib/II Study of LGX818 in Combination With MEK162 in Adult Patients With BRAF Dependent Advanced Solid Tumors

    Excerpt:
    ...- Written documentation of BRAF V600E mutation, or any other BRAF V600 mutation...
    Trial ID:
    NCT01543698
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancer

    Excerpt:
    ...- Presence of BRAF V600E in tumor tissue determined by local assay at any time prior to screening...
    Trial ID:
    ANCHOR-CRC
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Clin Cancer Res
    Title:

    A phase 1b/2 study of the BRAF inhibitor encorafenib plus the MEK inhibitor binimetinib in patients with BRAF V600E/K-mutant solid tumors

    Published date:
    07/15/2020
    Excerpt:
    …phase 1b/2 study reports the safety and activity of the first combination use with BRAF inhibitor (BRAFi) encorafenib plus MEK inhibitor (MEKi) binimetinib in patients with BRAF V600E-mutant solid tumors…In the phase 2 cohorts, confirmed responses were seen in 2 of 11 (18%) evaluable mCRC patients, 11 of 26 (42%) evaluable BRAFi-pretreated melanoma patients, and 28 of 42 (67%) BRAFi-naïve melanoma patients…The combination of encorafenib (450 mg) plus binimetinib (45 mg) showed acceptable tolerability and encouraging activity in patients with BRAF V600-mutant tumors…
    DOI:
    10.1158/1078-0432.CCR-19-3550
    Trial ID:
    NCT01543698