Infigratinib Yields PFS, ORR Benefit in Patients With Cholangiocarcinoma and FGFR2 Fusions

According to phase 2 study findings presented at the virtual 22nd ESMO World Congress on Gastrointestinal Cancer, third- and later-line treatment with infigratinib led to a meaningful benefit in survival and response among patients with cholangiocarcinoma (CCA) and FGFR2 fusions.

“To date, the outcome of patients with CCA and FGFR2 fusions receiving standard second-line chemotherapy is unknown,” wrote lead investigator Milind Javle, MD, The University of Texas MD Anderson Cancer Center, Houston, and colleagues.

A total of 71 patients (median age, 53 years) with advanced CCA and FGFR2 fusions who had received prior gemcitabine-based chemotherapy were enrolled in the single-arm study. These patients were given infigratinib 125 mg once daily on days 1 through 21, with cycles repeated every 28 days until unacceptable toxicity, disease progression, or withdrawal of consent occurred.

Dr Javle et al conducted a retrospective analysis of a subset of 37 (52%) patients, measuring outcomes including investigator-assessed progression-free survival (PFS) and the objective response rate after second-line chemotherapy (pre-infigratinib) and third-line or later-line infigratinib therapy.

The median PFS with standard second-line chemotherapy versus third- and later-line infigratinib was 4.63 months (95% CI, 2.69-7.16) versus 6.77 months (95% CI, 3.94-7.79), respectively. The ORR was 5.4% (95% CI, 0.7-18.2) versus 21.6% (95% CI, 9.8-38.2), respectively.

“Outcomes from second-line chemotherapy in patients with CCA and FGFR2 fusions were similar to those reported in the literature for all patients with CCA regardless of genomic status and remain dismal,” Dr Javle and colleagues wrote.

“Infigratinib administered as third- and later-line treatment resulted in a meaningful PFS and ORR benefit in patients with CCA and FGFR2 fusions,” they concluded.—Hina M. Porcelli

Javle M, Sadeghi S, Roychowdhury S, et al. Efficacy of second-line chemotherapy in patients with advanced or metastatic cholangiocarcinoma and FGFR2 fusions: A retrospective analysis. Presented at: the 22nd ESMO World Congress on Gastrointestinal Cancer; July 1-4, 2020; virtual. Abstract SO-5.