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Innovent Biologics Begins Phase III Trial of First-Line Pemazyre for Bile Duct Cancer in China

NEW YORK – Innovent Biologics said on Monday that it has dosed the first patient with advanced, FGFR2 rearrangement-positive bile duct cancer in a Phase III clinical trial of pemigatinib (Pemazyre) in China.

Jiangsu, China-based Innovent, which in 2018 obtained the rights to develop and commercialize Incyte's pemigatinib in mainland China, Hong Kong, Macau, and Taiwan, is specifically evaluating the agent in the first-line treatment setting. In the randomized, Phase III trial, researchers will compare the activity of pemigatinib and chemotherapy in patients with unresectable or metastatic cholangiocarcinoma whose tumors harbor FGFR2 rearrangements.

In April 2020, the US Food and Drug Administration granted accelerated approval to the FGFR1/2/3 inhibitor as a later-line treatment for cholangiocarcinoma with FGFR2 rearrangements based on the results of a Phase II, single-arm study. The FDA also approved Foundation Medicine's FoundationOne CDx next-generation sequencing assay as a companion diagnostic to identify FGFR2 fusion-positive cholangiocarcinoma patients who are eligible for pemigatinib.

In March 2021, both the European Commission and the Japanese Ministry of Health, Labor, and Welfare approved the drug for this same subset of previously treated cholangiocarcinoma patients.

According to Hui Zhou, Innovent's senior VP, pemigatinib's activity and safety in the treatment refractory setting for FGFR2 fusion-positive patients suggests that the agent could likewise benefit FGFR2 rearrangement-positive patients in the first-line setting in this Phase III trial.

"The poor prognosis and the side effects associated with systematic chemotherapy increase the urgency of improving upon the treatment efficacy as well as the quality of life of patients with cholangiocarcinoma," Zhou said in a statement. "Data from previous clinical trials of pemigatinib in participants with advanced cholangiocarcinoma with FGFR2 fusion as second line or later treatment has not only shown satisfactory safety results but also revealed compelling efficacy signals."