An open-label Phase III study for FIGHT-302 using pemigatinib (INCB54828) is announced by Incyte. It is a selective fibroblast growth factor receptor inhibitor in comparison to cisplatin with gemcitabine chemotherapy, which is the current treatment for patients with surgically unresectable or metastatic cholangiocarcinoma.
Most of the patients with cholangiocarcinoma do not effectively respond to currently available treatment and it cannot be surgically removed. Therefore, there is a requirement to develop new treatment options and FIGHT-302 is one of them.
Cholangiocarcinoma is a bile duct cancer, which is often identified during late stages (stage III and IV). It has a poor prognosis and is most common in individuals with more than 70 years age.
Progression free survival evaluated by independent review is the primary endpoint for FIGHT-302. Response duration, safety and quality of life impact, overall survival, disease control rate and overall response rate are its secondary endpoints.
Mr Vinod Arora, Principal Advisor, IGMPI
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