Innovent receives China NMPA approval for Pemazyre to treat locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion

Innovent Biologics, Inc. (Innovent), a world-class biopharmaceutical company, announced that the National Medical Products Administration (NMPA) has approved Pemazyre (pemigatinib) for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement as confirmed by a validated diagnostic test 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 markets, is the first selective tyrosine kinase inhibitor approved for the treatment of cholangiocarcinoma, a type of biliary tract cancer, in China, representing a new milestone following its approval in Hong Kong market in January 2022, and in the Taiwan market in June 2021. The approval in China was based on two clinical studies. One is the FIGHT-202 study, which is a phase 2, multi-center, open-label, single-arm study (NCT02924376) evaluating the safety and efficacy of pemigatinib in adult (age =18 years) patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGFR2 fusion or rearrangement. The other study was a bridging study (CIBI375A201, NCT04256980) conducted in China evaluating the safety and efficacy of pemigatinib in Chinese cholangiocarcinoma patients. The primary end point was overall response rate (ORR) evaluated by an independent radiological review committee (IRRC) per RECIST V1.1. In the FIGHT-202 study, as data cut of date (April 7th,2020), a total of 108 subjects with FGFR2 fusion/rearrangement were enrolled and orally received pemigatinib 13.5mg per day(Q3W 2 weeks on/1 week off), the IRRC-confirmed ORR was 37.0% (95% CI: 27.94%, 46.86%), including 4 complete responses(CR). The median duration of response (DOR) was 8.08 months with responses lasting = 6 months in 26 of the 40 (66.0%) responding patients and = 12 months in 15 (37.5%) patients. In study CIBI375A201, as of data cut-off date (January 29th, 2021), among 30 efficacy evaluable Chinese subjects enrolled, the IRRC-confirmed ORR was 50%(95% CI: 31.3%, 68.7%). The overall safety profiles of FIGHT-202 and the study CIBI375A201 are similar and the majority of the adverse events were grade 1 or 2 per CTCAE V5.0. Pemigatinib was generally well tolerated in Chinese patients with cholangiocarcinoma. Professor Jian Zhou in Zhong Shan Hospital Fudan University stated that:

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