Basilea starts new cohort in a study, testing derazantinib in iCCA

Basilea starts new cohort in a study, testing derazantinib in iCCA

July 1, 2019 Off By Dino Mustafić

Basilea Pharmaceutica has enrolled the first patient in a newly opened cohort in the ongoing FIDES-01 phase 2 registrational study with the panFGFR kinase inhibitor derazantinib in intrahepatic cholangio­carcinoma (iCCA), the company said Monday.

ICCA is affecting the part of the bile duct inside the liver and patients with advanced iCCA have very limited treatment options and a poor prognosis, Basilea explains.

According to Basilea’s press release, the additional cohort is open for enrollment of approximately 40 patients with FGFR2 gene mutations or amplifications in their tumors. The patients receive once-daily oral derazantinib, the drugmaker said.

Dr. Marc Engelhardt, Basilea’s Chief Medical Officer, said that, 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. He said that, to date, FGFR inhibitors have demonstrated clinical activity in FGFR2-fusion driven iCCA. Furthermore, assessing the activity of derazantinib in a broader range of FGFR2-driven tumors is therefore important to further define the full therapeutic potential of derazantinib in iCCA.

The FIDES-01 (Fibroblast growth factor Inhibition with DErazantinib in Solid tumors) study is a multi-center, open-label phase 2 registrational study of once-daily oral derazantinib for the treatment of patients with inoperable or advanced iCCA and FGFR2 gene fusions or FGFR2 gene mutations or amplifications, Basilea further said in the press release. It also noted that, in January 2019, a pre-planned interim analysis of the FGFR2 fusion-positive cohort of the study showed promising efficacy in this patient population and also confirmed the safety profile and tolerability of the drug candidate observed in previous clinical studies. Basilea said that the topline data for the cohort of FGFR2 fusion-positive patients are expected to be available around mid-2020.