Bridge Biotherapeutic’s announced its subsidiary, QED Therapeutics, has secured both Fast Track Designation in adults with first-line advanced or metastatic cholangiocarcinoma and Orphan Drug Designation for infigratinib for treatment of cholangiocarcinoma.
The company also announced that enrollment is ongoing and patient dosing has started in the PROOF trial, a Phase 3 clinical trial evaluating oral infigratinib in adults for first-line treatment of advanced cholangiocarcinoma with FGFR2 (fibroblast growth factor receptor 2) gene fusions or translocations. The PROOF trial will enroll approximately 384 patients who will be randomized 2:1 to infigratinib versus standard of care. The primary endpoint is progression-free survival compared to standard of care chemotherapy (gemcitabine and cisplatin).
About Infigratinib (BGJ398)
Infigratinib (BGJ398) is an orally administered FGFR1-3 tyrosine kinase inhibitor in development for the treatment of patients with FGFR-driven diseases, including cholangiocarcinoma (bile duct cancer. Because infigratinib sparingly inhibits FGFR4, patients may tolerate it better than pan–FGFR1-4 inhibitors. Infigratinib is not chemotherapy.
About Cholangiocarcinoma (bile duct cancer)
Cholangiocarcinoma affects approximately 8,000 to 10,000 individuals a year in the United States. FGFR genetic aberrations are present in about 20% of these cases. These types of aberrations include FGFR2 fusions (or translocations) in which 2 chromosomes exchange parts at the FGFR2 location resulting in a structural rearrangement.