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Therapy Name Lirafugratinib
Synonyms
Therapy Description

Lyrfigtu (lirafugratinib) is a selective, irreversible FGFR2 inhibitor that blocks FGFR2 signaling, potentially lead to tumor growth inhibition (PMID: 38300868). Lyrfigtu (lirafugratinib) is FDA-approved for use in patients with previously treated advanced or metastatic cholangiocarcinoma harboring FGFR2 fusion or rearrangement (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Lirafugratinib Lyrfigtu RLY4008|RLY 4008|RLY-4008 FGFR2 Inhibitor 24 Lyrfigtu (lirafugratinib) is a selective, irreversible FGFR2 inhibitor that blocks FGFR2 signaling, potentially lead to tumor growth inhibition (PMID: 38300868). Lyrfigtu (lirafugratinib) is FDA-approved for use in patients with previously treated advanced or metastatic cholangiocarcinoma harboring FGFR2 fusion or rearrangement (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FGFR2 amp stomach cancer sensitive Lirafugratinib Preclinical - Cell line xenograft Actionable In a preclinical study, Lyrfigtu (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 N549K endometrial cancer predicted - sensitive Lirafugratinib Preclinical - Cell culture Actionable In a preclinical study, Lyrfigtu (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 K310R FGFR2 N549K endometrial adenocarcinoma sensitive Lirafugratinib Preclinical - Cell line xenograft Actionable In a preclinical study, Lyrfigtu (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 rearrange cholangiocarcinoma sensitive Lirafugratinib FDA approved Actionable In a Phase I/II trial (ReFocus) that supported FDA approval, Lyrfigtu (lirafugratinib) treatment was safe and resulted in an objetive response rate of 47% (53/114, 3 complete and 50 partial responses), a median duration of response of 11.8 mo, a meidan progression-free survival of 11.3 mo, and median overall survial of 22.8 mo in FGFR inhibitor-naive cholangiocarcinoma patients harboring FGFR2 fusions or rearrangements (J Clin Oncol 44, 2026 (suppl 2; abstr 476); NCT04526106). detail... detail...
FGFR2 N549D Advanced Solid Tumor predicted - sensitive Lirafugratinib Preclinical - Biochemical Actionable In a preclinical study, Lyrfigtu (lirafugratinib) treatment inhibited Fgfr2 phosphorylation in cultured cells expressing FGFR2 N549D (PMID: 37270847). 37270847
FGFR2 V564L Advanced Solid Tumor predicted - sensitive Lirafugratinib Preclinical - Biochemical Actionable In a preclinical study, Lyrfigtu (lirafugratinib) treatment inhibited Fgfr2 phosphorylation in cultured cells expressing FGFR2 V564L (PMID: 37270847). 37270847
FGFR2 C383R breast cancer sensitive Lirafugratinib Preclinical - Cell culture Actionable In a preclinical study, Lyrfigtu (lirafugratinib) inhibited proliferation of a breast carcinoma cell line harboring FGFR2 C383R in culture (PMID: 37270847). 37270847
FGFR2 Y375C salivary gland carcinoma predicted - sensitive Lirafugratinib Case Reports/Case Series Actionable In a Phase I/II trial (ReFocus), Lyrfigtu (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 K659M Advanced Solid Tumor predicted - sensitive Lirafugratinib Preclinical - Biochemical Actionable In a preclinical study, Lyrfigtu (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, Lyrfigtu (lirafugratinib) treatment inhibited Fgfr2 phosphorylation in cultured cells expressing FGFR2 L617V (PMID: 37270847). 37270847
FGFR2 V564F Advanced Solid Tumor predicted - sensitive Lirafugratinib Preclinical - Biochemical Actionable In a preclinical study, Lyrfigtu (lirafugratinib) treatment inhibited Fgfr2 phosphorylation in cultured cells expressing FGFR2 V564F (PMID: 37270847). 37270847
FGFR2 N549H Advanced Solid Tumor predicted - sensitive Lirafugratinib Preclinical - Biochemical Actionable In a preclinical study, Lyrfigtu (lirafugratinib) treatment inhibited Fgfr2 phosphorylation in cultured cells expressing FGFR2 N549H (PMID: 37270847). 37270847
FGFR2 C383R FGFR2 N550D intrahepatic cholangiocarcinoma sensitive Lirafugratinib Preclinical - Pdx Actionable In a preclinical study, Lyrfigtu (lirafugratinib) inhibited tumor growth in a patient-derived xenograft (PDX) model of intrahepatic cholangiocarcinoma harboring FGFR2 C383R and FGFR2 N550D (PMID: 39226398). 39226398
FGFR2 fusion cholangiocarcinoma predicted - sensitive Lirafugratinib FDA approved Actionable In a Phase I/II trial (ReFocus) that supported FDA approval, Lyrfigtu (lirafugratinib) treatment was safe and resulted in an objetive response rate of 47% (53/114, 3 complete and 50 partial responses), a median duration of response of 11.8 mo, a meidan progression-free survival of 11.3 mo, and median overall survial of 22.8 mo in FGFR inhibitor-naive cholangiocarcinoma patients harboring FGFR2 fusions or rearrangements (J Clin Oncol 44, 2026 (suppl 2; abstr 476); NCT04526106). detail... detail...
FGFR2 K641N Advanced Solid Tumor predicted - sensitive Lirafugratinib Preclinical - Biochemical Actionable In a preclinical study, Lyrfigtu (lirafugratinib) treatment inhibited Fgfr2 phosphorylation in cultured cells expressing FGFR2 K641N (PMID: 37270847). 37270847
FGFR2 E565A Advanced Solid Tumor predicted - sensitive Lirafugratinib Preclinical - Biochemical Actionable In a preclinical study, Lyrfigtu (lirafugratinib) treatment inhibited Fgfr2 phosphorylation in cultured cells expressing FGFR2 E565A (PMID: 37270847). 37270847
FGFR2 amp colorectal adenocarcinoma sensitive Lirafugratinib Preclinical - Cell culture Actionable In a preclinical study, Lyrfigtu (lirafugratinib) inhibited proliferation of a colorectal adenocarcinoma cell line with FGFR2 amplification in culture (PMID: 37270847). 37270847

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT07359820 Phase II Lirafugratinib A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement (ReFocus202) Recruiting USA | GBR | FRA | ESP 1
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 Completed USA | SWE | NLD | ITA | GBR | FRA | ESP | DEU | AUS 4


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