Therapy Detail
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| Therapy Name | Cetuximab + Fluorouracil + Leucovorin + Vemurafenib |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Cetuximab | Erbitux | IMC-C225 | EGFR Antibody 56 | 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). |
| 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). |
| Vemurafenib | Zelboraf | RO5185426|PLX4032 | RAF Inhibitor (Pan) 27 | Zelboraf (vemurafenib) inhibits BRAF V600E, wild-type BRAF, ARAF, and CRAF (PMID: 20179705), which may result in an inhibition of the MAPK signaling pathway resulting in a reduction of tumor cell proliferation (PMID: 20823850). Zelboraf (vemurafenib) is FDA approved for BRAF V600E-mutant melanoma and for BRAF V600-positive Erdheim-Chester disease (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| BRAF V600E MAP2K1 K57T | colorectal cancer | predicted - resistant | Cetuximab + Fluorouracil + Leucovorin + Vemurafenib | Case Reports/Case Series | Actionable | In a Phase II trial (MODUL), a patient with metastatic colorectal cancer harboring BRAF V600E was found to have acquired MAP2K1 K57T prior to progression on treatment with the combination of Zelboraf (vemurafenib), Erbitux (cetuximab), Adrucil (fluorouracil), and Wellcovorin (leucovorin) (PMID: 36921494; NCT02291289). | 36921494 |
| BRAF V600E | colorectal cancer | no benefit | Cetuximab + Fluorouracil + Leucovorin + Vemurafenib | Phase II | Actionable | In a Phase II trial (MODUL), patients with metastatic colorectal cancer harboring BRAF V600E did not demonstrate improved progression-free survival when treated with the combination of Zelboraf (vemurafenib), Erbitux (cetuximab), Adrucil (fluorouracil), and Wellcovorin (leucovorin) compared to the control treatment of Avastin (bevacizumab) with a fluoropyrimidine (HR=0.95 and P=0.872) (PMID: 36921494; NCT02291289). | 36921494 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|
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