The study enrolled 21 GC and GEJ patients with FGFR2 gene amplification. 20 patients (95.2%) who had >1 post-baseline tumor assessment per RECIST v1.1 were evaluable. Confirmed objective response rate (cORR) was 23.8% (95% CI: 8.2 – 47.2), disease control rate (DCR) was 76.2% (95% CI: 52.8 – 91.8) and median duration of response (DOR) was 3.8 months (95% CI: 3.6 – NE). Median progression-free survival (mPFS) was 3.3 months (95% CI: 2.3 – 4.5) and median overall survival (mOS) was 8.0 months (95% CI: 4.1 – NE). Among 20 evaluable patients who had post-baseline assessments, cORR was 25.0% (95% CI: 8.7–49.1) and DCR was 80.0% (95% CI: 56.3–94.3).
Infigratinib was generally well tolerated with a manageable safety profile. There were no treatment-related adverse events (TRAEs) leading to dose discontinuation, death, or drug-induced liver injury.
“The encouraging data presented at ESMO highlight infigratinib’s potential to provide a meaningful clinical benefit to patients whose disease has progressed on other treatments,” said
FGFR pathway aberrations are common in multiple cancer types, including gastric cancer. Infigratinib is an ATP-competitive, FGFR1-3 selective oral tyrosine kinase inhibitor. Infigratinib received Breakthrough Therapy Designation from the
About the Study
The Phase 2 clinical trial is a multicenter, open-label, single-arm study in
About Infigratinib
Infigratinib is an orally administered, ATP-competitive, tyrosine kinase inhibitor of fibroblast growth factor receptor (FGFR) that targets the FGFR protein, blocking downstream activity. In clinical studies, infigratinib demonstrated a clinically meaningful rate of tumor shrinkage (overall response rate) and duration of response in cholangiocarcinoma. It is currently being evaluated in clinical studies for locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma, and other advanced solid tumors with FGFR genomic alterations.
About
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