Reference Detail

Request Content

Contact

Missing content? – Request curation!

Request curation for specific Genes, Variants, or PubMed publications.

Have questions, comments, or suggestions? - Let us know!

Email us at : ckbsupport@genomenon.com

Ref Type Journal Article
PMID (37889382)
Authors Deng T, Zhang L, Shi Y, Bai G, Pan Y, Shen A, Han X, Yang Z, Chen M, Zhou H, Luo Y, Zheng S, Ba Y
Title Pharmacokinetics, pharmacodynamics and efficacy of pemigatinib (a selective inhibitor of fibroblast growth factor receptor 1-3) monotherapy in Chinese patients with advanced solid tumors: a phase i clinical trial.
Journal Vol Issue Date Pages Journal Short Title
Investigational new drugs 41 6 2023 Dec 808-815 Invest New Drugs
URL
Abstract Text Pemigatinib is a selective fibroblast growth factor receptor (FGFR)1-3 inhibitor and has demonstrated acceptable tolerability and clinical activity in advanced solid tumors in Western population. This phase I trial evaluated pharmacokinetics/pharmacodynamics (PK/PD) characteristics, preliminary safety and efficacy of pemigatinib in Chinese patients with advanced, solid tumors. Patients with unresectable advanced or metastatic solid tumors bearing FGF/FGFR1-3 alterations received oral pemigatinib at 13.5 mg once daily (QD) on a 2-weeks-on/1-week-off schedule. The primary endpoint was PK/PD characteristics; secondary endpoints were safety and efficacy. Twelve patients were enrolled (median age: 61 years, 58.3% males). PK data demonstrated pemigatinib (13.5 mg QD) was rapidly absorbed with a geometric mean elimination half-life of 11.3 h. The geometric mean values of maximum serum concentration and area under the plasma concentration-time curve from 0 to 24 h at steady state were 215.1 nmol/L and 2636.9 h·nmol/L, respectively. The mean clearance adjusted by bioavailability at steady state was low (11.8 L/h), and the apparent oral volume of distribution was moderate (170.5 L). The PD marker, serum phosphate level, increased on days 8 and 15 of cycle 1 (mean: 2.25 mg/dL, CV% [percent coefficient of variation]: 31.3%) and decreased to baseline post 1 week off. Three (25.0%) patients experienced grade ≥ 3 treatment-emergent adverse events. Partial response was confirmed in one patient with FGFR1-mutant esophageal carcinoma and one with FGFR2-mutant cholagiocarcinoma. Pemigatinib had similar PK/PD characteristics to Western population and demonstrated an acceptable safety profile and potential anti-cancer benefit in Chinese patients with FGF/FGFR1-3 altered, advanced, solid tumor. (ClinicalTrials.gov: NCT04258527 [prospectively registered February 6, 2020]).

Filtering

  • Case insensitive filtering will display rows if any text in any cell matches the filter term
  • Use simple literal full or partial string matches
  • Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
  • Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

Sorting

  • Generally, the default sort order for tables is set to be first column ascending; however, specific tables may set a different default sort order.
  • Click on any column header arrows to sort by that column
  • Hold down the Shift key and click multiple columns to sort by more than one column. Be sure to set ascending or descending order for a given column before moving on to the next column.

Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
FGFR1 A354V missense unknown FGFR1 A354V lies within Ig-like C2-type domain 3 of the Fgfr1 protein (UniProt.org). A354V has been identified in the scientific literature (PMID: 37889382), but has not been biochemically characterized and therefore, its effect on Fgfr1 protein function is unknown (PubMed, Nov 2025).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FGFR2 F276C cholangiocarcinoma predicted - sensitive Pemigatinib Case Reports/Case Series Actionable In a Phase I trial, Pemazyre (pemigatinib) treatment resulted in an objective response rate of 16.7% (2/12, both partial responses) and a disease control rate of 41.7% (5/12) in patients with advanced solid tumors harboring FGFR1/2/3 alterations including amplification, mutation, or fusion, including a partial response in a patient with cholangiocarcinoma harboring FGFR2 F276C (PMID: 37889382; NCT04258527). 37889382
FGFR1 A354V esophageal carcinoma predicted - sensitive Pemigatinib Case Reports/Case Series Actionable In a Phase I trial, Pemazyre (pemigatinib) treatment resulted in an objective response rate of 16.7% (2/12, both partial responses) and a disease control rate of 41.7% (5/12) in patients with advanced solid tumors harboring FGFR1/2/3 alterations including amplification, mutation, or fusion, including a partial response in a patient with esophageal carcinoma harboring FGFR1 A354V (PMID: 37889382; NCT04258527). 37889382