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Association details:
| Biomarker: | FGFR2 fusion |
|---|---|
| Cancer: | Cholangiocarcinoma |
| Drug: | gunagratinib (ICP-192) (FGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A Study of ICP-192 in Patients With FGFR2-Rearranged Unresectable or Metastatic Intrahepatic Cholangiocarcinoma
Excerpt:
...FGFR2 fusion /rearrangement as confirmed by the central laboratory....
Trial ID:
Source:
Title:
Gunagratinib, a highly selective irreversible FGFR inhibitor, in patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR pathway alterations: A phase IIa dose-expansion study.
Published date:
01/17/2023
Excerpt:
Among the 17 patients who have completed at least one tumor assessment, 9 patients had confirmed partial response (PR) and 7 patients had stable disease (SD). The ORR was 52.9% (9/17). The disease control rate (DCR) was 94.1% (16/17). The median progression free survival (mPFS) was 6.93 months (95% CI, 5.42–not reached) (not mature at cutoff)...The study data demonstrated that gunagratinib is safe and well-tolerated in previously treated patients with locally advanced or metastatic CCA harboring FGFR2 gene fusions or rearrangements.
DOI:
10.1200/JCO.2023.41.3_suppl.572
Trial ID:
Source:
Title:
Phase I result of ICP-192 (gunagratinib), a highly selective irreversible FGFR inhibitor, in patients with advanced solid tumors harboring FGFR pathway alterations.
Published date:
05/19/2021
Excerpt:
...patients with cholangiocarcinoma harboring FGFR2 gene fusion/translocation received the treatment of gunagratinib daily at 12 mg continuously….the overall response rate (ORR) was 33.3%, including 1 patient (8.3%) of cholangiocarcinoma with complete response (CR) and 3 patients (25%) with partial response (PR). The disease control rate (DCR) was 91.7% (11 of 12 patients)...Anti-tumor activity was demonstrated in patients with FGF/FGFR gene aberrations in multiple tumor types, including cholangiocarcinoma...
DOI:
10.1200/JCO.2021.39.15_suppl.4092
Trial ID:
