Lancet Gastroenterol Hepatol: Efficacy and safety of Infigratinib in advanced cholangiocarcinoma with EGFR2 fusion or rearrangement

After the advancement of first-line gemcitabine treatment, there are few treatment options for patients with advanced cholangiocarcinoma

This study aims to evaluate the anti-tumor activity of Infigratinib in patients with locally advanced or metastatic cholangiocarcinoma who have received gemcitabine-based therapy and have FGFR2 mutations

This is a multi-center, open-label, single-arm Phase 2 study, recruiting from 18 academic centers and hospitals 18 years of age or older with histologically confirmed locally advanced or metastatic cholangiocarcinoma with EGFR2 fusion or rearrangement The patient was given Infigratinib 125 mg, orally, 1/day for 21 days and stopped for 7 days until the disease progressed, intolerable toxicity or death occurred

From June 23, 2014 to March 31, 2020, a total of 122 patients were recruited, of which 108 patients with EGFR2 fusion or rearrangement received at least one dose of Infigratinib and completed the entire analysis

The most common adverse reactions of any grade requiring emergency treatment were hyperphosphatemia (83 cases), stomatitis (59 cases), fatigue (43 cases), and hair loss (41 cases)

Infigratinib has good clinical activity and controllable adverse events in previously treated locally advanced or metastatic cholangiocarcinoma patients with FGFR2 gene fusion or rearrangement, and may be a potential new treatment option for such patients

Javle Milind,Roychowdhury Sameek,Kelley Robin Kate et al.