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Therapy Name	Lirafugratinib
Synonyms
Therapy Description	Lirafugratinib binds to and inhibits FGFR2, selectively targeting primary oncogenic FGFR2 mutations and leads to decreased FGFR2-dependent signaling, potentially resulting in inhibition of tumor cell proliferation (NCI Drug Dictionary; Journal of Clinical Oncology 39, no. 15_suppl).

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Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
Lirafugratinib		RLY4008\|RLY 4008\|RLY-4008	FGFR2 Inhibitor 24	Lirafugratinib binds to and inhibits FGFR2, selectively targeting primary oncogenic FGFR2 mutations and leads to decreased FGFR2-dependent signaling, potentially resulting in inhibition of tumor cell proliferation (NCI Drug Dictionary; Journal of Clinical Oncology 39, no. 15_suppl).

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Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
FGFR2 fusion	cholangiocarcinoma	predicted - sensitive	Lirafugratinib	Phase Ib/II	Actionable	In a Phase I/II trial (ReFocus), Lirafugratinib treatment resulted in radiographic tumor reductions in 64% (74/116) and partial responses/stable disease in 72% (83/116) of patients with advanced solid tumors harboring FGFR2 alterations, and an objective response rate of 52% (13/25) and a disease control rate of 88% (22/25) in FGFR inhibitor-naive cholangiocarcinoma patients harboring FGFR2 fusions or rearrangements (J Clin Oncol 41, 2023 (suppl 16; abstr 4009); NCT04526106).	detail...
FGFR2 Y375C	salivary gland carcinoma	predicted - sensitive	Lirafugratinib	Case Reports/Case Series	Actionable	In a Phase I/II trial (ReFocus), Lirafugratinib treatment resulted in a partial response with near complete resolution of liver metastases, and regression of lung and adrenal metastases in a patient with metastatic carcinoma of the right parotid salivary gland harboring FGFR2 Y375C (PMID: 37270847; NCT04526106).	37270847
FGFR2 C383R FGFR2 N550D	intrahepatic cholangiocarcinoma	sensitive	Lirafugratinib	Preclinical - Pdx	Actionable	In a preclinical study, Lirafugratinib inhibited tumor growth in a patient-derived xenograft (PDX) model of intrahepatic cholangiocarcinoma harboring FGFR2 C383R and FGFR2 N550D (PMID: 39226398).	39226398
FGFR2 amp	stomach cancer	sensitive	Lirafugratinib	Preclinical - Cell line xenograft	Actionable	In a preclinical study, Lirafugratinib treatment inhibited proliferation of gastric carcinoma cell lines with an FGFR2 amplification in culture, and led to tumor regression in a cell line xenograft model (PMID: 37270847).	37270847
FGFR2 K310R FGFR2 N549K	endometrial adenocarcinoma	sensitive	Lirafugratinib	Preclinical - Cell line xenograft	Actionable	In a preclinical study, Lirafugratinib inhibited proliferation of an endometrial adenocarcinoma cell line harboring FGFR2 N549K and FGFR K310R in culture, and led to tumor regression in a cell line xenograft model (PMID: 37270847).	37270847
FGFR2 amp	colorectal adenocarcinoma	sensitive	Lirafugratinib	Preclinical - Cell culture	Actionable	In a preclinical study, Lirafugratinib inhibited proliferation of a colorectal adenocarcinoma cell line with FGFR2 amplification in culture (PMID: 37270847).	37270847
FGFR2 C383R	breast cancer	sensitive	Lirafugratinib	Preclinical - Cell culture	Actionable	In a preclinical study, Lirafugratinib inhibited proliferation of a breast carcinoma cell line harboring FGFR2 C383R in culture (PMID: 37270847).	37270847
FGFR2 N549K	endometrial cancer	predicted - sensitive	Lirafugratinib	Preclinical - Cell culture	Actionable	In a preclinical study, Lirafugratinib treatment led to tumor regression in a cell line xenograft model of endometrial cancer harboring FGFR2 N549K (Cancer Res 2021;81(13_Suppl):Abstract nr 1455).	detail...
FGFR2 E565A	Advanced Solid Tumor	predicted - sensitive	Lirafugratinib	Preclinical - Biochemical	Actionable	In a preclinical study, Lirafugratinib treatment inhibited Fgfr2 phosphorylation in cultured cells expressing FGFR2 E565A (PMID: 37270847).	37270847
FGFR2 K641N	Advanced Solid Tumor	predicted - sensitive	Lirafugratinib	Preclinical - Biochemical	Actionable	In a preclinical study, Lirafugratinib treatment inhibited Fgfr2 phosphorylation in cultured cells expressing FGFR2 K641N (PMID: 37270847).	37270847
FGFR2 K659M	Advanced Solid Tumor	predicted - sensitive	Lirafugratinib	Preclinical - Biochemical	Actionable	In a preclinical study, Lirafugratinib treatment inhibited Fgfr2 phosphorylation in cultured cells expressing FGFR2 K659M (PMID: 37270847).	37270847
FGFR2 L617V	Advanced Solid Tumor	predicted - sensitive	Lirafugratinib	Preclinical - Biochemical	Actionable	In a preclinical study, Lirafugratinib treatment inhibited Fgfr2 phosphorylation in cultured cells expressing FGFR2 L617V (PMID: 37270847).	37270847
FGFR2 N549D	Advanced Solid Tumor	predicted - sensitive	Lirafugratinib	Preclinical - Biochemical	Actionable	In a preclinical study, Lirafugratinib treatment inhibited Fgfr2 phosphorylation in cultured cells expressing FGFR2 N549D (PMID: 37270847).	37270847
FGFR2 N549H	Advanced Solid Tumor	predicted - sensitive	Lirafugratinib	Preclinical - Biochemical	Actionable	In a preclinical study, Lirafugratinib treatment inhibited Fgfr2 phosphorylation in cultured cells expressing FGFR2 N549H (PMID: 37270847).	37270847
FGFR2 V564F	Advanced Solid Tumor	predicted - sensitive	Lirafugratinib	Preclinical - Biochemical	Actionable	In a preclinical study, Lirafugratinib treatment inhibited Fgfr2 phosphorylation in cultured cells expressing FGFR2 V564F (PMID: 37270847).	37270847
FGFR2 V564L	Advanced Solid Tumor	predicted - sensitive	Lirafugratinib	Preclinical - Biochemical	Actionable	In a preclinical study, Lirafugratinib treatment inhibited Fgfr2 phosphorylation in cultured cells expressing FGFR2 V564L (PMID: 37270847).	37270847

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT04526106	Phase I	Lirafugratinib	REFOCUS: a First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients with ICC and Other Advanced Solid Tumors	Active, not recruiting	USA \| SWE \| NLD \| ITA \| GBR \| FRA \| ESP \| DEU \| AUS	4

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