Therapy Detail

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Therapy Name Binimetinib + Cetuximab + Encorafenib
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Binimetinib Mektovi ARRY-162|ARRY-438162|MEK162 MEK inhibitor (Pan) 23 MEK1 Inhibitor 25 MEK2 Inhibitor 23 Mektovi (binimetinib) inhibits MEK1 and MEK2 resulting in inhibition of growth factor-mediated signaling and decreased tumor cell proliferation (PMID: 23587417). Mektovi (binimetinib) in combination with Braftovi (encorafenib) is FDA approved for use in patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation (FDA.gov).
Cetuximab Erbitux IMC-C225 EGFR Antibody 52 Erbitux (cetuximab) is a monoclonal antibody directed against EGFR, which inhibits signal transduction and cell proliferation (PMID: 28695301). Erbitux (cetuximab) is FDA approved for use in head and neck squamous cell carcinoma and KRAS wild-type, EGFR positive colorectal cancer (FDA.gov).
Encorafenib Braftovi LGX818 BRAF Inhibitor 24 Braftovi (encorafenib) is an inhibitor of Raf kinase with selective activity against BRAF V600E, resulting in growth inhibition (PMID: 24864047). Braftovi (encorafenib) is FDA approved for use in combination with Mektovi (binimetinib) in patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, and in patients with metastatic non-small cell lung cancer harboring BRAF V600E, and in combination with Erbitux (cetuximab) in patients with metastatic colorectal cancer with BRAF V600E (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
BRAF V600E colorectal cancer sensitive Binimetinib + Cetuximab + Encorafenib Phase III Actionable In a Phase III (BEACON CRC) trial, Braftovi (encorafenib), Mektovi (binimetinib), and Erbitux (cetuximab) combination treatment (n=111) resulted in improved median overall survival (9.0 vs 5.4 months, HR=0.52, p<0.001), confirmed response rate (26% vs 2%, p<0.001), and median progression-free survival (4.3 vs 1.5 months, HR=0.38, p<0.001) compared to control (n=107) in patients with metastatic colorectal cancer harboring BRAF V600E (PMID: 31566309; NCT02928224). 31566309
BRAF V600E colorectal cancer sensitive Binimetinib + Cetuximab + Encorafenib Phase II Actionable In a Phase II (ANCHOR CRC) trial, Braftovi (encorafenib), Mektovi (binimetinib), and Erbitux (cetuximab) combination treatment (n=95) demonstrated an acceptable safety profile and resulted in a confirmed objective response rate of 47.8% (44/92), a disease control rate of 88% (81/92), a median progression-free survival of 5.8 months, and a median overall survival of 18.3 months in patients with metastatic colorectal cancer harboring BRAF V600E (PMID: 36763936; NCT03693170). 36763936
BRAF V600E colorectal cancer sensitive Binimetinib + Cetuximab + Encorafenib Clinical Study Actionable In a retrospective study, combination treatment with Mektovi (binimetinib), Erbitux (cetuximab), and Braftovi (encorafenib) resulted in an objective response rate of 31%, a disease control rate of 78%, a median progression-free survival of 4.2 mo, and a median overall survival of 7.1 mo in patients with metastatic colorectal cancer harboring BRAF V600E (PMID: 35696748). 35696748

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02928224 Phase III Cetuximab + Encorafenib Binimetinib + Cetuximab + Encorafenib Cetuximab + Irinotecan Cetuximab + Fluorouracil + Irinotecan + Leucovorin 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 (BEACON CRC) Completed USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 17
NCT05510895 Phase II Binimetinib + Cetuximab + Encorafenib Neoadjuvant Encorafenib, Binimetinib and Cetuximab for Patients With BRAF V600E Mutated/pMMR Localized Colorectal Cancer (NeoBRAF) Recruiting DEU 0
NCT03693170 Phase II Binimetinib + Cetuximab + Encorafenib Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancer (ANCHOR-CRC) Active, not recruiting USA | ITA | GBR | FRA | ESP | BEL | AUT 2
NCT03803553 Phase III Binimetinib + Cetuximab + Encorafenib Nivolumab Fluorouracil + Irinotecan + Leucovorin Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer Recruiting USA 0
NCT05203172 FDA approved Encorafenib Binimetinib + Encorafenib Binimetinib + Encorafenib + Ribociclib Binimetinib + Cetuximab + Encorafenib Binimetinib The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials Recruiting USA | ITA | FRA | ESP | DEU | CAN | AUS 8


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