Therapy Detail

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Therapy Name Cetuximab + Encorafenib + Fluorouracil + Irinotecan + Leucovorin
Synonyms Encorafenib + Cetuximab + FOLFIRI
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Cetuximab Erbitux IMC-C225 EGFR Antibody 77 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 26 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 that interferes with DNA and RNA synthesis, thereby preventing cancer cell growth (PMID: 28520376). Adrucil (fluorouracil) is FDA-approved for use in patients with adenocarcinoma of the colon, rectum, breast, stomach, and pancreas (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).
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).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
BRAF V600E rectum cancer sensitive Cetuximab + Encorafenib + Fluorouracil + Irinotecan + Leucovorin Guideline Actionable Braftovi (encorafenib) in combination with Erbitux (cetuximab) and FOLFIRI is included in guidelines as a preferred initial therapy (category 2A) for patients with advanced or metastatic rectal cancer harboring BRAF V600E (NCCN.org). detail...
BRAF V600E colorectal cancer sensitive Cetuximab + Encorafenib + Fluorouracil + Irinotecan + Leucovorin FDA approved - On Companion Diagnostic Actionable In a Phase III trial (BREAKWATER) that supported FDA approval, Braftovi (encorafenib) in combination with Erbitux (cetuximab) and FOLFIRI significantly improved objective response rate (64.4%, 47/73 vs 39.2%, 29/74; OR=2.756, p=0.0011) and progression-free survival (15.2 vs 8.3 mo; HR=0.44, p=0.0002) compared to FOLFIRI with or without bevacizumab in metastatic colorectal cancer patients harboring BRAF V600E, and median overall survival was not estimable vs 20.3 mo (HR=0.56) (PMID: 42219860; NCT04607421). detail... detail... detail... 42219860
BRAF V600E colorectal cancer sensitive Cetuximab + Encorafenib + Fluorouracil + Irinotecan + Leucovorin Preclinical - Pdx Actionable In a preclinical study, treatment with the combination of Erbitux (cetuximab), Braftovi (encorafenib), and FOLFIRI resulted in increased tumor growth inhibition and tumor regression compared to Erbitux (cetuximab) plus Braftovi (encorafenib) or FOLFIRI alone in patient-derived xenograft (PDX) models of colorectal cancer harboring BRAF V600E and increased survival and tumor growth inhibition in cell line xenograft models (PMID: 37040395). 37040395
BRAF V600E colon cancer sensitive Cetuximab + Encorafenib + Fluorouracil + Irinotecan + Leucovorin Guideline Actionable Braftovi (encorafenib) in combination with Erbitux (cetuximab) and FOLFIRI is included in guidelines as a preferred initial therapy (category 2A) for patients with advanced or metastatic colon cancer harboring BRAF V600E (NCCN.org). detail...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT06640166 Phase II Cetuximab + Encorafenib + Fluorouracil + Irinotecan + Leucovorin Encorafenib + Cetuximab Beyond Progression in Combination With FOLFIRI in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer Progressing on Encorafenib + Cetuximab. (ECLYPse) Recruiting ITA 0
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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