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    Association details:
    Biomarker:BRAF V600E
    Cancer:Melanoma
    Drug:Zelboraf (vemurafenib) (BRAF inhibitor, BRAF V600E inhibitor) +
    Cotellic (cobimetinib) (MEK1 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    FDA
    Excerpt:
    COTELLIC is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib.
    Test:
    cobas® 4800 BRAF V600 Mutation Test
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    ESMO.org
    Excerpt:
    Table 3. ESMO-MCBS table for new therapies/indications in melanoma...First-line unresectable or metastatic melanoma with the BRAF V600E mutation.
    DOI:
    10.1093/annonc/mdz411
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Lancet Oncol
    Title:

    Cobimetinib combined with vemurafenib in advanced BRAFV600-mutant melanoma (coBRIM): updated efficacy results from a randomised, double-blind, phase 3 trial

    Published date:
    07/29/2016
    Excerpt:
    ...495 eligible adult patients were enrolled and randomly assigned to the cobimetinib plus vemurafenib group...Median overall survival was 22·3 months (95% CI 20·3–not estimable) for cobimetinib and vemurafenib...data confirm the clinical benefit of cobimetinib combined with vemurafenib and support the use of the combination as a standard first-line approach to improve survival in patients with advanced BRAFV600-mutant melanoma.
    DOI:
    10.1016/S1470-2045(16)30122-X
    Trial ID:
    coBRIM
    Evidence Level:
    Sensitive: B - Late Trials
    New
    Source:
    Lancet Oncol
    Title:

    Cobimetinib combined with vemurafenib in advanced BRAF(V600)-mutant melanoma (coBRIM): updated efficacy results from a randomised, double-blind, phase 3 trial

    Excerpt:
    These data confirm the clinical benefit of cobimetinib combined with vemurafenib and support the use of the combination as a standard first-line approach to improve survival in patients with advanced BRAF(V600)-mutant melanoma.
    DOI:
    10.1016/S1470-2045(16)30122-X
    Trial ID:
    coBRIM
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Treatment of a Resistant Disease Using Decitabine Combined With Vemurafenib Plus Cobimetinib

    Excerpt:
    ...Any patient with metastatic melanoma (any site) whose tumor is V600EBRAF positive, regardless of prior treatment....
    Trial ID:
    NCT01876641
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Vemurafenib Plus Cobimetinib in Advanced or Metastatic Melanoma Patients

    Excerpt:
    ...Documentation of BRAFV600 mutation-positive status in melanoma tumor tissue BRAF V600 mutation test; 6....
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    EADO-WCM 2021
    Title:

    P-126 Efficacy of neoadjuvant targeted therapy for resectable stage IIIB-D or IV BRAF V600 mutation-positive melanoma – real world evidence

    Published date:
    04/15/2021
    Excerpt:
    Patients (pts) with marginally resectable bulky stage III or resectable stage IV histologically confirmed melanoma were enrolled. BRAF V600 mutation status and pathology were confirmed...23 pts were treated with dabrafenib and trametinib, 3 pts were treated with vemurafenib and cobimetinib, and 3 with vemurafenib monotherapy.... BRAFi/MEKi combination is an effective and safe regimen in the perioperative treatment of melanoma.
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    J Transl Med
    Title:

    Impact of initial treatment and prognostic factors on postprogression survival in BRAF-mutated metastatic melanoma treated with dacarbazine or vemurafenib?±?cobimetinib: a pooled analysis of four clinical trials

    Published date:
    08/03/2020
    Excerpt:
    Recursive partitioning analysis (RPA) was performed to model relationships between prespecified covariates and ppOS in patients with BRAFV600-mutated metastatic melanoma who had experienced progressive disease (PD) following treatment with cobimetinib plus vemurafenib, vemurafenib monotherapy, or dacarbazine in the BRIM-2, BRIM-3, BRIM-7, and coBRIM studies....Across treatment cohorts, patients treated with immunotherapy or targeted therapy after PD had better ppOS than those given other treatments....
    DOI:
    https://doi.org/10.1186/s12967-020-02458-x
    Evidence Level:
    Sensitive: C3 – Early Trials
    New
    Source:
    Lancet Oncol
    Title:

    Combination of vemurafenib and cobimetinib in patients with advanced BRAFV600-mutated melanoma: a phase 1b study

    Excerpt:
    ...phase 1b study in patients with advanced BRAF V600-mutated melanoma….patients received vemurafenib 720 mg or 960 mg twice a day continuously and cobimetinib 60 mg, 80 mg...The combination of vemurafenib and cobimetinib was safe and tolerable when administered at the respective maximum tolerated doses.The combination has promising antitumour activity and further clinical development is warranted in patients with advanced BRAF V600-mutated melanoma...
    DOI:
    https://doi.org/10.1016/S1470-2045(14)70301-8