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.

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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.

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.

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“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.