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• W4361958271 abstract "<div>AbstractPurpose:<p><i>FGFR</i> genomic alterations (amplification, mutations, and/or fusions) occur in ∼8% of gliomas, particularly <i>FGFR1</i> and <i>FGFR3</i>. We conducted a multicenter open-label, single-arm, phase II study of a selective FGFR1–3 inhibitor, infigratinib (BGJ398), in patients with <i>FGFR</i>-altered recurrent gliomas.</p>Patients and Methods:<p>Adults with recurrent/progressive gliomas harboring <i>FGFR</i> alterations received oral infigratinib 125 mg on days 1 to 21 of 28-day cycles. The primary endpoint was investigator-assessed 6-month progression-free survival (PFS) rate by Response Assessment in Neuro-Oncology criteria. Comprehensive genomic profiling was performed on available pretreatment archival tissue to explore additional molecular correlations with efficacy.</p>Results:<p>Among 26 patients, the 6-month PFS rate was 16.0% [95% confidence interval (CI), 5.0–32.5], median PFS was 1.7 months (95% CI, 1.1–2.8), and objective response rate was 3.8%. However, 4 patients had durable disease control lasting longer than 1 year. Among these, 3 had tumors harboring activating point mutations at analogous positions of <i>FGFR1</i> (K656E; <i>n</i> = 2) or <i>FGFR3</i> (K650E; <i>n</i> = 1) in pretreatment tissue; an <i>FGFR3-TACC3</i> fusion was detected in the other. Hyperphosphatemia was the most frequently reported treatment-related adverse event (all-grade, 76.9%; grade 3, 3.8%) and is a known on-target toxicity of FGFR inhibitors.</p>Conclusions:<p>FGFR inhibitor monotherapy with infigratinib had limited efficacy in a population of patients with recurrent gliomas and different <i>FGFR</i> genetic alterations, but durable disease control lasting more than 1 year was observed in patients with tumors harboring <i>FGFR1</i> or <i>FGFR3</i> point mutations or <i>FGFR3-TACC3</i> fusions. A follow-up study with refined biomarker inclusion criteria and centralized <i>FGFR</i> testing is warranted.</p></div>" @default.
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• W4361958271 date "2023-03-31" @default.
• W4361958271 modified "2023-10-03" @default.
• W4361958271 title "Data from Infigratinib in Patients with Recurrent Gliomas and <i>FGFR</i> Alterations: A Multicenter Phase II Study" @default.
• W4361958271 doi "https://doi.org/10.1158/1078-0432.c.6531203.v1" @default.
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