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    Association details:
    Biomarker:FGFR2 fusion
    Cancer:Cholangiocarcinoma
    Drug:gunagratinib (ICP-192) (pan-FGFR inhib)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrialsregister.eu
    Title:

    Efficacy and safety of ICP-192 in patients with unresectable or metastatic intrahepatic cholangiocarcinoma who have failed prior treatment and have FGFR2 fusion/rearrangement.

    Excerpt:
    ......
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    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:
    NCT05678270
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO-GI 2023
    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:
    ICP-CL-00301
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2021
    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:
    ICP-CL-00301