Therapy Detail

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Therapy Name Cetuximab + Encorafenib
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 (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, and in combination with Erbitux (cetuximab) in patients with metastatic colorectal cancer with BRAF V600E (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 L115P colorectal cancer sensitive Cetuximab + Encorafenib Preclinical - Cell culture Actionable In a preclinical study, combination therapy consisting of Erbitux (cetuximab) and Encorafenib (LGX818) inhibited survival of colorectal cancer cells harboring BRAF V600E that acquired a MAP2K1 L115P mutation and subsequent resistance to Tafinlar (dabrafenib) and Mekinist (trametinib) combination treatment in culture (PMID: 27312529). 27312529
BRAF V600E colon neuroendocrine neoplasm predicted - sensitive Cetuximab + Encorafenib Case Reports/Case Series Actionable In a clinical case study, treatment with the combination of Erbitux (cetuximab) and Braftovi (encorafenib) resulted in reduced liver metastasis and a progression-free survival of 14 months in a patient with colorectal neuroendocrine carcinoma harboring BRAF V600E (PMID: 37981300). 37981300
BRAF V600E colorectal cancer sensitive Cetuximab + Encorafenib Guideline Actionable Braftovi (encorafenib) in combination with Erbitux (cetuximab) is included in the Pan-Asian Guidelines Adaptation (PAGA) as a second- or subsequent-line therapy for patients with advanced or metastatic colorectal cancer harboring BRAF V600E (PMID: 37236086; ESMO.org). detail... 37236086
BRAF V600E colorectal cancer sensitive Cetuximab + Encorafenib Guideline Actionable Braftovi (encorafenib) in combination with Erbitux (cetuximab) is included in guidelines as second-line or subsequent therapy for patients with metastatic colorectal cancer harboring BRAF V600E (PMID: 36307056; ESMO.org). 36307056 detail...
BRAF V600E colorectal cancer sensitive Cetuximab + Encorafenib FDA approved - On Companion Diagnostic Actionable In a Phase III (BEACON CRC) trial that supported FDA approval, Braftovi (encorafenib) and Erbitux (cetuximab) combination treatment (n=113) resulted in improved median overall survival (8.4 vs 5.4 months, HR=0.60, p<0.001), confirmed response rate (20% vs 2%, p<0.001), and median progression-free survival (4.2 vs 1.5 months, HR=0.40, p<0.001) compared to control (n=107) in patients with metastatic colorectal cancer harboring BRAF V600E (PMID: 31566309; NCT02928224). detail... 31566309
BRAF V600E colorectal cancer sensitive Cetuximab + Encorafenib Preclinical - Cell culture Actionable In a preclinical study, combination therapy consisting of Erbitux (cetuximab) and Encorafenib (LGX818) inhibited survival of colorectal cancer cell lines harboring BRAF V600E in culture (PMID: 27312529). 27312529
BRAF V600E colorectal cancer sensitive Cetuximab + Encorafenib Clinical Study Actionable In a retrospective study, combination treatment with Erbitux (cetuximab) and Braftovi (encorafenib) resulted in an objective response rate of 17%, a disease control rate of 65%, a median progression-free survival of 4.6 mo, and a median overall survival of 7.2 mo in patients with metastatic colorectal cancer harboring BRAF V600E (PMID: 35696748). 35696748
BRAF V600E colorectal cancer sensitive Cetuximab + Encorafenib Clinical Study Actionable In a retrospective analysis, real-world treatment with Erbitux (cetuximab) and Braftovi (encorafenib) with or without Mektovi (binimetinib) led to an objective response rate (ORR) of 32.2% (57/201, 2 complete responses (CR)), disease control rate of 71.2% (126/201), median progression-free survival of 4.5 months, and median overall survival of 9.2 months in metastatic colorectal cancer patients with BRAF V600E, with an ORR of 32% (50/180, 1 CR) in patients treated with doublet therapy (PMID: 39255538). 39255538
BRAF V600E colon cancer sensitive Cetuximab + Encorafenib Guideline Actionable Braftovi (encorafenib) in combination with Erbitux (cetuximab) is included in guidelines as primary or subsequent therapy for patients with colon cancer harboring BRAF V600E (NCCN.org). detail...
BRAF V600E rectum cancer sensitive Cetuximab + Encorafenib Guideline Actionable Braftovi (encorafenib) in combination with Erbitux (cetuximab) is included in guidelines as primary or subsequent therapy for patients with rectal cancer harboring BRAF V600E (NCCN.org). detail...
BRAF V600E pseudomyxoma peritonei sensitive Cetuximab + Encorafenib Preclinical - Pdx & cell culture Actionable In a preclinical study, treatment with the combination of Braftovi (encorafenib) and Erbitux (cetuximab) inhibited viability and induced apoptosis in a patient-derived pseudomyxoma peritonei cell line harboring BRAF V600E in culture and inhibited tumor growth and improved survival of a patient-derived xenograft (PDX) model (PMID: 39018564). 39018564
BRAF V600E appendix adenocarcinoma sensitive Cetuximab + Encorafenib Guideline Actionable Braftovi (encorafenib) in combination with Erbitux (cetuximab) is included in guidelines for patients with advanced or metastatic appendiceal adenocarcinoma harboring BRAF V600E (NCCN.org). detail...
BRAF V600E MAP2K1 V211D colorectal cancer resistant Cetuximab + Encorafenib Preclinical - Cell culture Actionable In a preclinical study, colorectal cancer cells harboring BRAF V600E that acquired a MAP2K1 V211D mutation and subsequent resistance to Erbitux (cetuximab) and Selumetinib (AZD6244) combination treatment were resistant to combination therapy consisting of Erbitux (cetuximab) and Encorafenib (LGX818) in culture (PMID: 27312529). 27312529

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT05308446 Phase II Cetuximab + Encorafenib Cetuximab + Encorafenib + Nivolumab Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Mutation Active, not recruiting USA 1
NCT06578559 Phase II Cetuximab + Encorafenib Phase II Study of ctDNA-guided Encorafenib Plus Cetuximab Retreatment in Patients BRAF V600E Mutated mCRC (BRICKET) Recruiting ITA 0
NCT05706779 Phase II Cetuximab + Encorafenib Encorafenib Plus Cetuximab in a Neoadjuvant Setting in Patients With BRAF Mutation Localised Colon or Upper Rectum Cancer (NEORAF) Recruiting FRA 0
NCT01719380 Phase Ib/II Cetuximab + Encorafenib Alpelisib + Cetuximab + Encorafenib Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer Completed USA | NOR | NLD | ITA | FRA | ESP | DEU | CAN | BEL | AUS 2
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
NCT05710406 Phase II Cetuximab + Encorafenib Testing the Use of BRAF-Targeted Therapy After Surgery and Usual Chemotherapy for BRAF-Mutated Colon Cancer Recruiting USA 0
NCT02928224 Phase III Cetuximab + Encorafenib Binimetinib + Cetuximab + Encorafenib Cetuximab + Irinotecan Cetuximab + Fluorouracil + Irinotecan + Leucovorin Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer (BEACON CRC) Completed USA | TUR | POL | NOR | NLD | ITA | ISR | HUN | GBR | FRA | ESP | DNK | DEU | CZE | CAN | BRA | BEL | AUT | AUS | ARG 7


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