Therapy Detail
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| Therapy Name | Cetuximab + Encorafenib + Fluorouracil + Leucovorin + Oxaliplatin |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| 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, and in combination with Braftovi (encorafenib) with or without mFOLFOX6 in patients with metastatic colorectal cancer with BRAF V600E (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, in combination with Erbitux (cetuximab) with or without mFOLFOX6 in patients with metastatic colorectal cancer with BRAF V600E (FDA.gov). |
| Fluorouracil | Adrucil | 5-FU|5-Fluorouracil | Chemotherapy - Antimetabolite 14 | Adrucil (fluorouracil) is an antimetabolite chemotherapeutic agent, which interferes with DNA and RNA synthesis thereby preventing cancer cell growth and is FDA approved for colorectal, breast, stomach, and pancreatic cancer (FDA.gov). |
| Leucovorin | Wellcovorin | Calcium folinate|Calcium citrovorum factor|folinic acid | Chemotherapy - Antimetabolite 14 | Wellcovorin (leucovorin) is a metabolite of folate that enhances the efficacy of fluoruracil (PMID: 32490554). |
| Oxaliplatin | Eloxatin | Diaminocyclohexane Oxalatoplatinum | Chemotherapy - Platinum 7 | Eloxatin (oxaliplatin) is comprised of a platinum complex, which causes DNA-platinum cross-links, inhibition of DNA replication and transcription, and cell toxicity, and is FDA approved for colorectal cancer (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 | Cetuximab + Encorafenib + Fluorouracil + Leucovorin + Oxaliplatin | Preclinical - Cell line xenograft | Actionable | In a preclinical study, treatment with the combination of Erbitux (cetuximab), Braftovi (encorafenib), and FOLFOX resulted in increased tumor growth inhibition and survival compared to Erbitux (cetuximab) plus Braftovi (encorafenib) or FOLFOX alone in colorectal cancer cell line xenograft models harboring BRAF V600E (PMID: 37040395). | 37040395 |
| BRAF V600E | colorectal cancer | sensitive | Cetuximab + Encorafenib + Fluorouracil + Leucovorin + Oxaliplatin | FDA approved - On Companion Diagnostic | Actionable | In a Phase III trial (BREAKWATER) that supported FDA approval, Braftovi (encorafenib) in combination with Erbitux (cetuximab) and mFOLFOX6 (n=27) or FOLFIRI (n=30) were tolerated and resulted in a median duration of treatment of 14 and 15 weeks, respectively, in patients with metastatic colorectal cancer harboring BRAF V600E, with treatment ongoing in 79% (45/57) of the patients at data cutoff date (J Clin Oncol Vol 40, Number 4 Suppl (Feb 2022); NCT04607421). | detail... detail... detail... detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04607421 | Phase III | Bevacizumab + Capecitabine + Oxaliplatin Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin Cetuximab + Encorafenib Cetuximab + Encorafenib + Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab + Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Bevacizumab + Fluorouracil + Irinotecan + Leucovorin Cetuximab + Encorafenib + Fluorouracil + Irinotecan + Leucovorin | A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer | Active, not recruiting | USA | SWE | SVK | POL | NZL | NOR | NLD | ITA | GBR | FIN | ESP | DNK | DEU | CZE | CAN | BRA | BGR | BEL | AUS | ARG | 9 |
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