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    DRUG:

    Braftovi (encorafenib)

    i
    Other names: W-0090, W 0090, LGX818, NVP-LGX818, NVP-LGX818-NXA, ONO-7702, PF-07263896, W0090, LGX-818, LGX 818, NVPLGX818, NVP LGX818, ONO7702, ONO 7702, PF07263896, PF 07263896
    Company:
    Medison, Nerviano Medical Sciences, Ono Pharma, Pfizer, Pierre Fabre
    Drug class:
    BRAF V600E inhibitor, cRAF inhibitor
    Related drugs:
    4d
    Exploratory Analysis of Biomarkers and Treatment Outcomes From the COLUMBUS Study in BRAF V600E/K-Mutant Advanced or Metastatic Melanoma. (PubMed, Clin Cancer Res)
    The greatest benefits of encorafenib plus binimetinib were observed in patients with evidence of high TMB and/or tumor immune infiltration, suggesting potential immune contributions to efficacy, which were not observed with vemurafenib. BRAF V600 detectability in ctDNA appears to have utility as a marker of prognosis and response in this population.
    Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • IFNG (Interferon, gamma)
    |
    PD-L1 expression • BRAF V600E • TMB-H • BRAF V600 • BRAF V600K
    |
    Zelboraf (vemurafenib) • Mektovi (binimetinib) • Braftovi (encorafenib)
    12d
    OCEANII: Phase II Study Investigating the Combination of Encorafenib and Binimetinib in BRAF V600E Mutated Chinese Patients With Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=63, Active, not recruiting, Pierre Fabre Medicament | Trial completion date: Sep 2026 --> Dec 2026
    Trial completion date
    |
    BRAF V600E • BRAF V600
    |
    Mektovi (binimetinib) • Braftovi (encorafenib)
    13d
    ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer (clinicaltrials.gov)
    P1, N=100, Not yet recruiting, M.D. Anderson Cancer Center
    New P1 trial
    |
    MSI (Microsatellite instability)
    |
    Avastin (bevacizumab) • Erbitux (cetuximab) • 5-fluorouracil • Vectibix (panitumumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Lumakras (sotorasib) • Braftovi (encorafenib) • irinotecan • Tukysa (tucatinib) • Krazati (adagrasib) • Lonsurf (trifluridine/tipiracil) • leucovorin calcium
    14d
    BRICKET: Phase II Study of ctDNA-guided Encorafenib Plus Cetuximab Retreatment in Patients BRAF V600E Mutated mCRC (clinicaltrials.gov)
    P2, N=16, Active, not recruiting, Gruppo Oncologico del Nord-Ovest | Recruiting --> Active, not recruiting
    Enrollment closed • Circulating tumor DNA
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • MSI (Microsatellite instability) • MAP2K1 (Mitogen-activated protein kinase kinase 1)
    |
    BRAF V600E • MSI-H/dMMR • BRAF V600 • KRAS wild-type • NRAS wild-type
    |
    Guardant360® CDx
    |
    Erbitux (cetuximab) • Braftovi (encorafenib)
    16d
    Binimetinib and encorafenib for the treatment of advanced solid tumors with non-V600E BRAF mutations: results from the Phase II BEAVER trial. (PubMed, Nat Commun)
    CDK4/6 and SHP2 emerge as mediators of intrinsic resistance to BRAF/MEK inhibition in Class 2 & 3 BRAF mutant tumors. Therapeutic strategies combining CDK4/6 or SHP2 inhibitors with BRAF/MEK inhibitors in preclinical models show greater efficacy than BRAF/MEK inhibitors alone in these cancers.
    P2 data • Journal
    |
    BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • MAP2K1 (Mitogen-activated protein kinase kinase 1)
    |
    BRAF V600E • NRAS mutation
    |
    Mektovi (binimetinib) • Braftovi (encorafenib)
    22d
    Pharmacist-Led Prevention of Recurrent Cetuximab Infusion Reactions. (PubMed, Cureus)
    A 69-year-old woman with metastatic colorectal cancer (RAS wild-type, microsatellite instability-high, BRAF V600E mutation) receiving encorafenib/binimetinib plus cetuximab developed Grade 2 IR during her first cetuximab infusion (approximately 98 min after initiation)...After discontinuing the infusion, she was treated with oxygen, d-chlorpheniramine, and famotidine, allowing completion at a reduced rate...The generalizability of the findings is limited due to the single-patient design. Prospective validation comparing H1 alone versus combined H1 + H2 premedication, using predefined infusion-rate algorithms, is warranted.
    Journal • MSi-H Biomarker
    |
    BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
    |
    BRAF V600E • MSI-H/dMMR • BRAF V600 • RAS wild-type
    |
    Erbitux (cetuximab) • Mektovi (binimetinib) • Braftovi (encorafenib)
    1m
    Current advances in colorectal cancer treatment: a review of recent clinical trials. (PubMed, Expert Opin Pharmacother)
    Notable findings include durable survival with pembrolizumab and nivolumab + ipilimumab in MSI-H/dMMR mCRC, efficacy of fruquintinib in refractory disease, and promising early outcomes with SCRT-based immunochemotherapy in LARC. Recent trials support precision oncology in CRC, highlighting durable benefits of targeted and immune therapies. However, heterogeneity in trial designs and underrepresentation of real-world populations limit generalizability.
    Review • Journal
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab) • Braftovi (encorafenib) • Fruzaqla (fruquintinib)
    1m
    Switch from cetuximab to panitumumab during encorafenib-based therapy in BRAF V600E mutated metastatic colorectal cancer: an international multicenter analysis from the AGEO group. (PubMed, Clin Res Hepatol Gastroenterol)
    No new IRRs nor toxic deaths were reported. ENCO-PANI appears to be as safe and effective in pts treated for a BRAFm mCRC unable to continue CET and may represent a valid alternative therapeutic option in this setting.
    Journal
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF V600E • MSI-H/dMMR • BRAF V600
    |
    Erbitux (cetuximab) • Vectibix (panitumumab) • Braftovi (encorafenib)
    1m
    TRIDeNT: Nivolumab With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients With BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma (clinicaltrials.gov)
    P2, N=52, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    BRAF mutation • BRAF V600
    |
    Opdivo (nivolumab) • Mekinist (trametinib) • Tafinlar (dabrafenib) • Mektovi (binimetinib) • Braftovi (encorafenib)
    2ms
    Intracranial antitumor efficacy of combination treatment with encorafenib plus binimetinib in BRAF V600E-mutated anaplastic thyroid carcinoma. (PubMed, Auris Nasus Larynx)
    The patient was initially diagnosed with T4bN1bM1 and experienced disease progression following surgery and lenvatinib treatment. This possibility is supported by reliable evidence for the use of BRAF plus MEK inhibitor for brain metastasis from BRAF-mutated malignant melanoma. We conclude that encorafenib plus binimetinib treatment for brain metastasis from BRAF-mutated thyroid cancer is a safe and effective treatment choice.
    Journal
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF V600E • BRAF V600
    |
    Lenvima (lenvatinib) • Mektovi (binimetinib) • Braftovi (encorafenib)