Basilea Pharmaceutica’s analysis of the registrational phase 2 study of potential of derazantinib in the treatment of FGFR-driven tumors, also confirmed the safety profile and tolerability of the drug candidate observed in previous clinical studies.
Dr. Marc Engelhardt, Chief Medical Officer of Basilea, is pleased with the achieved important milestone. He said that the response rate and the safety profile at the time of the interim analysis are promising, especially considering the poor outcomes with chemotherapy in this group of patients reported in the literature. “We are looking forward to the final data once the study is completed mid-2020,” he said.
He added: “The results of the interim analysis underscore the potential of derazantinib in the treatment of FGFR-driven tumors”
The company plans to extend the clinical development program of derazantinib, by starting a phase 2 study in other types of FGFR-driven solid tumors, in the mid-2019. Basilea plans to also expand the ongoing iCCA study by adding a separate cohort of patients with FGFR gene mutations to assess the potential expanded utility of derazantinib in the treatment of iCCA, said Engelhardt in a statement.