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Therapy Name	Lifirafenib
Synonyms
Therapy Description	Lifirafenib (BGB-283) is a dual RAF kinase and EGFR inhibitor, which may lead to decreased tumor cell proliferation and reduced growth of tumors with activation of BRAF and/or EGFR (PMID: 26208524, PMID: 32182156).

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Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
Lifirafenib		BGB-283	BRAF Inhibitor 26 EGFR Inhibitor (Pan) 63	Lifirafenib (BGB-283) is a dual RAF kinase and EGFR inhibitor, which may lead to decreased tumor cell proliferation and reduced growth of tumors with activation of BRAF and/or EGFR (PMID: 26208524, PMID: 32182156).

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Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
BRAF V600X	Advanced Solid Tumor	predicted - sensitive	Lifirafenib	Phase I	Actionable	In a Phase I trial, Lifirafenib (BGB-283) treatment demonstrated safety and resulted in partial response (PR) in 15.1% (8/53) of advanced solid tumor patients harboring a BRAF mutation, including 5 patients with BRAF V600E/K-mutant melanoma, 2 patients with BRAF V600E-mutant thyroid cancer, and 1 patient with BRAF V600E-mutant low-grade serous ovarian carcinoma, complete response in 1.9% (1/53), in a patient with melanoma, and stable disease in 50.9% (27/53) (PMID: 32182156; NCT02610361).	32182156
BRAF V600E	thyroid cancer	predicted - sensitive	Lifirafenib	Case Reports/Case Series	Actionable	In a Phase I trial, Lifirafenib (BGB-283) treatment resulted in partial response in 15.1% (8/53) of solid tumor patients with BRAF mutations, including 2 thyroid cancer patients harboring BRAF V600E (1 in dose-escalation phase, 1 in the dose-expansion), and in the dose-expansion phase 1 of 3 thyroid cancer patients harboring a BRAF V600 mutation demonstrated a partial response and 2 demonstrated stable disease, resulting in a disease control rate of 100% (3/3) (PMID: 32182156; NCT02610361).	32182156
BRAF V600E	ovarian serous carcinoma	predicted - sensitive	Lifirafenib	Case Reports/Case Series	Actionable	In a Phase I trial, Lifirafenib (BGB-283) treatment demonstrated safety and resulted in partial response (PR) in 15.1% (8/53) of advanced solid tumor patients harboring a BRAF mutation, including 1 patient with BRAF V600E-mutant low-grade serous ovarian cancer (PMID: 32182156; NCT02610361).	32182156
BRAF V600E/K	melanoma	predicted - sensitive	Lifirafenib	Case Reports/Case Series	Actionable	In a Phase I trial, Lifirafenib (BGB-283) treatment resulted in partial response in 15.1% (8/53) of solid tumor patients with BRAF mutations, including 5 of 23 patients with melanoma harboring BRAF V600E or V600K overall, and in the dose expansion phase 57.1% (4/7) patient with BRAF V600-mutant melanoma had a partial response (PMID: 32182156; NCT02610361).	32182156
BRAF V600E	colorectal cancer	sensitive	Lifirafenib	Preclinical - Pdx & cell culture	Actionable	In a preclinical study, Lifirafenib (BGB-283) inhibited Braf phosphorylation and cell proliferation in colorectal cancer cell lines harboring BRAF V600E in culture, and resulted in partial tumor regression in both cell line and patient-derived xenograft models (PMID: 26208524).	26208524
BRAF G469A	lung adenocarcinoma	sensitive	Lifirafenib	Preclinical - Patient cell culture	Actionable	In a preclinical study, cells derived from a lung adenocarcinoma patient harboring BRAF G469A were sensitive to treatment with Lifirafenib (BGB-283) in culture, demonstrating inhibition of cell growth (PMID: 32540409).	32540409
BRAF L597V	lung adenocarcinoma	sensitive	Lifirafenib	Preclinical - Patient cell culture	Actionable	In a preclinical study, cells derived from a lung adenocarcinoma patient harboring BRAF L597V were sensitive to treatment with Lifirafenib (BGB-283) in culture, demonstrating inhibition of cell growth (PMID: 32540409).	32540409
BRAF V600E	Advanced Solid Tumor	sensitive	Lifirafenib	Preclinical - Cell culture	Actionable	In a preclinical study, Lifirafenib (BGB-283) inhibited viability of a variety of cancer cell lines harboring BRAF V600E in culture (PMID: 26208524).	26208524
BRAF V600E	melanoma	sensitive	Lifirafenib	Preclinical - Cell culture	Actionable	In a preclinical study, Lifirafenib (BGB-283) inhibited Braf phosphorylation and cell proliferation in melanoma cell lines harboring BRAF V600E in culture (PMID: 26208524).	26208524
BRAF V600E	melanoma	sensitive	Lifirafenib	Preclinical - Cell culture	Actionable	In a preclinical study, Lifirafenib (BGB-283) treatment inhibited viability of a melanoma cell line harboring BRAF V600E in culture (PMID: 31618628).	31618628
BRAF wild-type	Advanced Solid Tumor	no benefit	Lifirafenib	Preclinical - Cell culture	Actionable	In a preclinical study, a variety of BRAF wild-type tumor cell lines were insensitive to Lifirafenib (BGB-283) in culture (PMID: 26208524).	26208524
BRAF L485_P490delinsFS	Advanced Solid Tumor	predicted - sensitive	Lifirafenib	Preclinical - Biochemical	Actionable	In a preclinical study, Lifirafenib (BGB-283) inhibited Mek and Erk phosphorylation in cells expressing BRAF L485_P490delinsFS in culture (PMID: 37656784).	37656784

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT02610361	Phase I	Lifirafenib	Study of the Safety and Pharmacokinetics of BGB-283 in Patients With Solid Tumors	Completed	NZL \| AUS	0

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