ESMO World GI: Third- or Later-Line Treatment With Infigratinib in Patients With Cholangiocarcinoma and FGFR2 Fusions

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At the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer 2020 Virtual, Javle et al reported that third- and later-line treatment with the selective fibroblast growth factor receptor (FGFR) 1-3 inhibitor infigratinib resulted in a progression-free survival and overall response rate benefit for patients with cholangiocarcinoma and FGFR2 fusions (Abstract SO-5).

The authors also reported that outcomes with second-line chemotherapy in patients with cholangiocarcinoma and FGFR2 fusions were similar to those reported in the literature for all patients with cholangiocarcinoma—regardless of genomic status—and remain “dismal.”

According to the study team, chemotherapy is the most common second-line treatment in patients with cholangiocarcinoma. FGFR2 fusions occur in 13% to 17% of patients with cholangiocarcinoma, and several targeted tyrosine kinase inhibitors are in development for this patient population. However, the outcome of patients with cholangiocarcinoma and FGFR2 fusions receiving standard second-line chemotherapy is unknown.

Phase II Trial

Seventy-one patients with advanced cholangiocarcinoma and FGFR2 fusions who had undergone prior treatment with gemcitabine-based chemotherapy were enrolled in a single-arm phase II study. Patients received infigratinib (previously known as BGJ398) at 125 mg orally once daily on days 1–21. Cycles were repeated every 28 days until unacceptable toxicity, disease progression, investigator discretion, or withdrawal of consent.

A retrospective analysis of a subset of patients who received infigratinib as third- or later-line treatment was performed. Investigator-assessed progression-free survival and overall response rate per Response Evaluation Criteria in Solid Tumors version 1.1 following second-line chemotherapy (pre-infigratinib) and third-line or later-line therapy with infigratinib were calculated.

Of the 71 patients, 44 were women; the median patient age was 53 years. Of patients with FGFR2 fusions who were enrolled at the time of analysis, 37 patients (52%) were included in this retrospective analysis.


Median progression-free survival with standard second-line chemotherapy was 4.63 months (95% confidence interval [CI] = 2.69–7.16) compared with 6.77 months (95% CI = 3.94–7.79) with third- and later-line infigratinib.

The overall response rate for second-line chemotherapy was 5.4% (95% CI = 0.7–18.2) compared with 21.6% (95% CI = 9.8–38.2) for third- and later-line infigratinib.

According to the authors, infigratinib administered as third- and later-line treatment resulted in a meaningful benefit.

Disclosure: This study was funded by QED Therapeutics, Inc.

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