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    Association details:
    Biomarker:BRAF V600E
    Cancer:Colorectal Cancer
    Drug:Braftovi (encorafenib) (BRAF inhibitor, cRAF inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    New
    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: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer

    Excerpt:
    ...- Locally confirmed BRAF V600E mutation in tumor tissue or blood...
    Trial ID:
    SEAMARK
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Phase I Study of Oral LGX818 in Adult Patients With Advanced or Metastatic BRAF Mutant Melanoma

    Excerpt:
    ...Written documentation of BRAF V600E mutation, or any other BRAF V600 mutation....
    Trial ID:
    NCT01436656
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrialsregister.eu
    Title:

    The SEAMARK Study: Phase 2 Study of First-line Encorafenib andCetuximab Plus Pembrolizumab in Participants With BRAF V600E-mutant, MSIH/dMMR Metastatic Colorectal Cancer

    Excerpt:
    ...Locally confirmed BRAF V600E mutation in tumor tissue or blood (eg, ctDNA genetic testing) as determined by either PCR or NGS-based local laboratory assay in a CLIA- or similarly certified laboratory.Screening Inclusion Criteria3. ...
    Trial ID:
    2021-003715-26
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer

    Excerpt:
    ...- Histologically or cytologically confirmed Stage IV CRC that contains BRAF V600E mutation -...
    Trial ID:
    BREAKWATER
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Study Evaluating the Combination of Encorafenib and Cetuximab Versus Irinotecan/Cetuximab or Infusional 5-fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab in Chinese Patients With BRAF V600E Mutant Metastatic Colorectal Cancer.

    Excerpt:
    ...- Presence of a BRAF V600E mutation in tumor tissue previously determined by a local assay at any time before screening or by the central laboratory....
    Trial ID:
    NAUTICALCRC
    Less C2 evidence
    Evidence Level:
    Sensitive: D – Preclinical
    Source:
    Oncotarget
    Title:

    Paradox breaker BRAF inhibitors have comparable potency and MAPK pathway reactivation to encorafenib in BRAF mutant colorectal cancer

    Published date:
    08/25/2020
    Excerpt:
    BRAF V600E-mutated colorectal (WiDr, RKO, Colo 201, and LS411N) and melanoma (G361 and A375) cell lines were treated with each drug covering a 10,000-fold concentration range....Encorafenib was significantly more effective than vemurafenib in 4 out of 6 cell lines (P = 0.0023 LS411N, P = 0.0002 WiDr, P < 0.0001 A375 and Colo 201).
    DOI:
    https://doi.org/10.18632/oncotarget.27681