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Association details:
| Biomarker: | FGFR2 mutation |
|---|---|
| Cancer: | Cholangiocarcinoma |
| Drug: | Lytgobi (futibatinib) (FGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A Study of TAS-120 in Patients With Advanced Solid Tumors
Excerpt:
...Intrahepatic or extrahepatic cholangiocarcinoma with FGFR2 gene fusions or other FGFR2 abnormalities, i.e., gene mutations (see Appendix A), rearrangements or amplifications...
Trial ID:
Source:
Title:
1383P - Phase I study of the irreversible FGFR inhibitor futibatinib in Japanese patients with advanced solid tumors: Updated dose expansion results and activity in gastric cancer
Published date:
09/13/2021
Excerpt:
In EX, pts with adv FGF/FGFR-aberrant tumors and no alternative treatment options received futibatinib...In the QD dosing cohorts (N=33), confirmed partial responses (PRs) were observed in 3 pts with GC and 1 pt with cholangiocarcinoma (CCA)...The CCA pt with a confirmed PR had an FGFR2 mutation.
Source:
Title:
54P - Efficacy and safety of futibatinib in intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 fusions/other rearrangements: Subgroup analyses of a phase II study (FOENIX-CCA2)
Published date:
09/14/2020
Excerpt:
Pts received oral futibatinib 20 mg 1x/day until PD/intolerance...In pts with confirmed FGFR2 alterations, ORR was 36.2% (21/58 fusions) and 44.4% (4/9 rearrangements). ORR was 33.3% in pts with FGFR2-BICC1. Best overall response in pts with comutations of interest is shown in the table below. These interim data demonstrate manageable AEs and efficacy of futibatinib in iCCA with FGFR2 fusions/other rearrangements. Responses were observed across pt subgroups, including those with common FGFR2 fusions, comutations, and poor prognostic factors.
Trial ID:
