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 58 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) 28 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 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
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

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries


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