Innovent Biologics, Inc. announced that the results of the Phase 2 study in Chinese patients with advanced cholangiocarcinoma were released at the European Society for Medical Oncology (ESMO) Congress 2021. This study, which is a bridging study of the FIGHT-202, is a Phase 2, open-label, multi-center, single-arm study to evaluate the efficacy and safety of pemigatinib a selective fibroblast growth factor receptor (FGFR) inhibitor – in Chinese patients with unresectable, advanced/recurrent or metastatic cholangiocarcinoma(CCA) with FGFR2 fusion/rearrangement that failed to prior systemic therapy. As of January 29, 2021, the data cutoff date, 3 subjects were enrolled and treated at 9mg pemigatinib in stage 1 to evaluate pharmacokinetic (PK) in Chinese population. The other 31 subjects with documented FGFR2 fusion or arrangement were enrolled in stage 2 and received 13.5mg pemigatinib. Subjects in both stages were orally given pemigatinib QD on a 2 weeks on/1 week off schedule until disease progression, unacceptable toxicity, withdrawal of consent, or physician decision. The primary endpoint was objective response rate (ORR) assessed by independent radiological review committee (IRRC) per RECIST V1.1 in 31 patients enrolled in stage 2. 30 subjects in stage 2 were included in the efficacy evaluable population with 1 participant excluded due to inadequate FGFR2 aberrant frequency. All 34 subjects in both stages were included for safety analysis. As of data cutoff date, each subject experienced at least 1 treatment-related adverse event(TRAE), the most common TRAE were hyperphosphatemia(73.5%), xerostomia(55.9%) and alopecia(50.0%), and 14.7% had grade 3 or higher TRAEs. Three participants had SAEs, which were rectal polyps, abnormal liver function and bile duct infection. There was no treatment discontinuation and deaths due to TRAE.