Innovent : Pemazyre Approved In Hong Kong For Treatment Of Adults With Metastatic Cholangiocarcinoma

(RTTNews) - Innovent Biologics Inc. (IVBXF.OB) said Monday that the Hong Kong Department of Health has approved Pemazyre or pemigatinib for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Pemazyre, discovered by Incyte and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan, is the first tyrosine kinase inhibitor approved for the treatment of cholangiocarcinoma, a type of biliary tract cancer, in Hong Kong market.

The approval was based on the FIGHT-202 study, which is a Phase 2, multi-center, open-label, single-arm study evaluating the safety and efficacy of Pemazyre in adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGFR2 fusion or rearrangement.

The median duration of response was 8.08 months with responses lasting greater than or equal to 6 months in 26 of the 40 (66.0%) responding patients and greater than or equal to 12 months in 15 (37.5%) patients.

The safety analysis, including 147 patients, demonstrated that pemigatinib was generally well tolerated. Hyperphosphatemia was the most common (58.5%) treatment-emergent adverse event.