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| Molecular Profile | BRAF V600E |
| Therapy | Cetuximab + Encorafenib + Fluorouracil + Irinotecan + Leucovorin |
| Indication/Tumor Type | colorectal cancer |
| Response Type | sensitive |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| 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 |
| PubMed Id | Reference Title | Details |
|---|---|---|
| Full reference... | ||
| Braftovi (encorafenib) FDA Drug Label | Full reference... | |
| Erbitux (cetuximab) FDA Drug Label | Full reference... | |
| (37040395) | Antitumor Efficacy of Dual Blockade with Encorafenib + Cetuximab in Combination with Chemotherapy in Human BRAFV600E-Mutant Colorectal Cancer. | Full reference... |
| (42219860) | A randomised study of encorafenib, cetuximab, and FOLFIRI versus FOLFIRI with or without bevacizumab in BRAF V600E-mutant colorectal cancer: BREAKWATER Cohort 3. | Full reference... |