Basilea Pharmaceutica has enrolled the first patient in a newly opened cohort as part of the ongoing FIDES-01 Phase II registrational study on the panFGFR kinase inhibitor derazantinib in patients suffering from intrahepatic cholangio­carcinoma (iCCA).

iCCA impacts the part of the bile duct inside the liver. Patients suffering from advanced iCCA have a poor prognosis with only limited treatment options.

iCCA accounts for 10%-20% of all primary liver cancers.

This new additional cohort will see enrolment of around 40 patients suffering from FGFR2 gene mutations or amplifications in their tumors.

Patients will receive once-daily oral derazantinib. The researchers will analyse the drug candidate’s anti-cancer activity in terms of response rate, progression-free survival, overall survival and duration of response. This examination will help them in further exploring the safety and tolerability of the drug candidate.

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Basilea Pharmaceutica chief medical officer Dr Marc Engelhardt said: “Based on preclinical models and clinical data, derazantinib may provide clinical benefit to patients with iCCA harboring a broad range of different FGFR2 aberrations, including gene fusions, mutations, and amplifications, which are considered to be relevant oncogenic drivers.

“To date, FGFR inhibitors have demonstrated clinical activity in FGFR2-fusion driven iCCA. Assessing the activity of derazantinib in a broader range of FGFR2-driven tumours is therefore important to further define the full therapeutic potential of derazantinib in iCCA.”

FIDES-01 is a multi-centre, open-label registrational trial of once-daily oral derazantinib to treat patients suffering from advanced or inoperable iCCA and FGFR2 gene fusions or FGFR2 gene mutations or amplifications.

Topline data for the group of FGFR2 fusion-positive patients are expected to be available around mid-2020.

Derazantinib, previously known as ARQ 087, is an investigational orally administered small molecule panFGFR kinase inhibitor showing strong activity against FGFR1, FGFR2, and FGFR3.