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Therapy Name | Binimetinib + Cetuximab + Encorafenib |
Synonyms | |
Therapy Description | |
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). |
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 |
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 |