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) 26 MEK1 Inhibitor 26 MEK2 Inhibitor 24 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 61 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 25 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 K601E colon adenocarcinoma predicted - sensitive Binimetinib + Cetuximab + Encorafenib Case Reports/Case Series Actionable In a clinical case study, third-line treatment with the combination of Mektovi (binimetinib), Erbitux (cetuximab), and Braftovi (encorafenib) resulted in improvement in the pleural effusion and ascites in a patient with metastatic colon adenocarcinoma harboring BRAF K601E, however, progression occurred after 2 months of treatment (PMID: 39072179). 39072179
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
BRAF V600E colorectal cancer sensitive Binimetinib + Cetuximab + Encorafenib Clinical Study Actionable In a retrospective analysis, real-world treatment with Erbitux (cetuximab) and Braftovi (encorafenib) with or without Mektovi (binimetinib) led to an objective response rate (ORR) of 32.2% (57/201, 2 complete responses (CR)), disease control rate of 71.2% (126/201), median progression-free survival of 4.5 months, and median overall survival of 9.2 months in metastatic colorectal cancer patients with BRAF V600E, with an ORR of 33.3% (7/21, 1 CR) in patients treated with triplet therapy (PMID: 39255538). 39255538
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 pancreatic ductal adenocarcinoma predicted - sensitive Binimetinib + Cetuximab + Encorafenib Case Reports/Case Series Actionable In a clinical case study, third-line treatment with the combination of Mektovi (binimetinib), Erbitux (cetuximab), and Braftovi (encorafenib) resulted in a partial response with a 74% decrease in primary tumor size in a patient with metastatic pancreatic ductal adenocarcinoma harboring BRAF V600E (PMID: 39461261). 39461261
BRAF V600E MAP2K1 F53L colorectal cancer predicted - resistant Binimetinib + Cetuximab + Encorafenib Case Reports/Case Series Actionable In a Phase III (BEACON CRC) trial, two patients with colorectal cancer harboring BRAF V600E progressed on the combination treatment of Braftovi (encorafenib), Mektovi (binimetinib), and Erbitux (cetuximab), and were found to have acquired MAP2K1 F53L in end-of-treatment ctDNA samples (PMID: 39313594; NCT02928224). 39313594

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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 | TUR | POL | NOR | NLD | ITA | ISR | HUN | GBR | FRA | ESP | DNK | DEU | CZE | CAN | BRA | BEL | AUT | AUS | ARG 7
NCT03803553 Phase III Binimetinib + Cetuximab + Encorafenib Nivolumab Fluorouracil + Irinotecan + Leucovorin Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer Recruiting USA 0
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) Completed USA | NLD | ITA | GBR | FRA | ESP | BEL | AUT 1
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 | SVK | NLD | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CZE | CAN | BRA | AUS 4


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