Therapy Detail

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Therapy Name Cetuximab + Irinotecan + 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).
Irinotecan Camptosar CPT-11 TOPO1 inhibitor 11 Camptosar (irinotecan) inhibits Topoisomerase-I activity, resulting in inhibition of DNA replication, and potentially leading to cell death and is indicated as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic or recurrent colorectal carcinoma (FDA.gov).
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 V47_M438del BRAF V600E colon adenocarcinoma predicted - resistant Cetuximab + Irinotecan + Vemurafenib Case Reports/Case Series Actionable In a clinical case study, BRAF V47_M438del (reported as deletion of exons 2-10) was identified in the post-progression biopsy of a patient with colon adenocarcinoma harboring BRAF V600E, who previously responded to the combination of Captosar (irinotecan), Erbitux (cetuximab), and Zelboraf (vemurafenib) (PMID: 32669268). 32669268
BRAF V600E colorectal cancer sensitive Cetuximab + Irinotecan + Vemurafenib Preclinical - Cell line xenograft Actionable In a preclinical study, Zelboraf (vemurafenib) treatment in combination with Erbitux (cetuximab) and Camptosar (irinotecan) enhanced tumor growth inhibition and increased survival in a cell line xenograft model of colorectal cancer harboring BRAF V600E (PMID: 22180495). 22180495
BRAF V600E colorectal cancer sensitive Cetuximab + Irinotecan + Vemurafenib Phase II Actionable In a Phase II trial (SWOG1406), addition of Zelboraf (vemurafenib) to Camptosar (irinotecan) plus Erbitux (cetuximab) improved progression-free survival (4.4 vs. 2.0 mo, HR 0.50, p=0.001), response rate (17% vs 4%, p=0.05), and disease control rate (67% vs. 22%, p<0.001) in patients with metastatic colorectal cancer harboring BRAF V600E (PMID: 33356422; NCT02164916). 33356422

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT01787500 Phase I Cetuximab + Irinotecan + Vemurafenib Vemurafenib, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or That Cannot Be Removed by Surgery Active, not recruiting USA 0
NCT02164916 Phase II Cetuximab + Irinotecan Cetuximab + Irinotecan + Vemurafenib S1406 Phase II Study of Irinotecan and Cetuximab With or Without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer Completed USA 0


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