Cholangiocarcinoma affects approximately 8,000 to 10,000 individuals a year in the United States.1,2 FGFR genetic aberrations are present in about 20% of these cases.3-6 These types of aberrations include FGFR2 fusions (or translocations) in which 2 chromosomes exchange parts at the FGFR2 location resulting in a structural rearrangement.6,7
In early clinical trials, infigratinib has shown promising clinical activity in cholangiocarcinoma with FGFR2 fusions.8
The single arm, open-label, Phase 2 trial for infigratinib is being conducted in patients with previously treated, advanced cholangiocarcinoma with FGFR2 fusions.8 The trial remains open and is currently enrolling.9
In patients with potential for confirmation (patients completed [or discontinued prior to] 6 cycles). Investigator confirmed.
The primary endpoint of this trial was objective response rate (CR+PR). Disease control rate, best overall response, and progression-free survival were secondary endpoints.8
In the interim analysis, the most common treatment-emergent adverse events (all grades) included hyperphosphatemia (73%), fatigue (49%), stomatitis (45%), alopecia (38%), and constipation (35%). Most adverse events were manageable with drug treatment and routine supportive care.8 The adverse events observed with infigratinib were as expected based on published data for FGFR inhibitor therapies.8,11,12
The best overall response is the best response recorded from the start of treatment until the end of treatment.
The objective response rate is the sum of the CR rate and the PR rate, where CR is 100% reduction in target lesion size or complete tumor disappearance and PR is a ≥30% reduction in the sum of target lesion diameter.
Javle M, Kelley RK, Roychowdhury S, et al. A phase II study of infigratinib (BGJ398), an FGFR-selective tyrosine kinase inhibitor (TKI), in patients with previously-treated advanced cholangiocarcinoma containing FGFR2 fusions. Poster presented at: ESMO 2018 Congress; October 19-23, 2018; Munich, Germany.
Hollebecque A, Borad M, Sahai V, et al. Interim results of fight-202, a phase 2, open-label, multicenter study of INCB054828 in patients with previously treated advanced/metastatic or surgically unresectable cholangiocarcinoma (CCA) with/without fibroblast growth factor (FGF)/FGF receptor genetic alterations. Poster presented at: ESMO 2018 Congress; October 19-23, 2018; Munich, Germany.