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Ref Type Journal Article
PMID (39919334)
Authors Satoh T, Barthélémy P, Nogova L, Honda K, Hirano H, Lee KW, Rha SY, Ryu MH, Park JO, Doi T, Ajani J, Hangai N, Kremer J, Mina M, Liu M, Shitara K
Title Phase 2 study of futibatinib in patients with gastric or gastroesophageal junction cancer harboring FGFR2 amplifications.
Journal Vol Issue Date Pages Journal Short Title
European journal of cancer (Oxford, England : 1990) 218 2025 Jan 27 115262 Eur J Cancer
URL
Abstract Text Aberrant fibroblast growth factor receptor (FGFR)-driven signaling, predominantly arising from FGFR2 amplification, plays a key role in gastric cancer pathogenesis. This open-label, phase 2 study evaluated the efficacy and safety of futibatinib, an irreversible FGFR1-4 inhibitor, in patients with gastric or gastroesophageal junction (GEJ) cancer harboring FGFR2 amplifications.Patients were treated with futibatinib 20 mg orally once daily in a 28-day cycle. The primary endpoint was objective response rate (ORR) per independent central review. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety.Among 28 treated patients, the ORR per independent central review was 17.9 %, comprising five patients with a partial response (median duration of response, 3.9 months), and an additional nine patients with stable disease for a disease control rate of 50.0 %. Median PFS per independent central review and median OS were 2.9 and 5.9 months, respectively. The most common treatment-related adverse events (any grade) were hyperphosphatemia (89.3 %), decreased appetite (32.1 %), and increased aspartate aminotransferase (21.4 %). Only one (3.6 %) patient discontinued study treatment due to an adverse event. Futibatinib demonstrated modest antitumor activity with a safety profile consistent with previous reports in patients with gastric or GEJ cancer harboring FGFR2 amplifications, potentially warranting further investigation.

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FGFR2 amp stomach cancer sensitive Futibatinib Phase II Actionable In a Phase II trial, Lytgobi (futibatinib) treatment of patients with gastric (n=23) or gastroesophageal junction cancer (n=5) harboring FGFR2 amplification resulted in an objective response rate of 17.9% (5/28, all partial responses), disease control rate of 50.0% (14/28), median duration of response of 3.9 months, median progression-free survival of 2.9 months, and median overall survival of 5.9 months by independent central review (PMID: 39919334; NCT04189445). 39919334