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Association details:
| Biomarker: | FGFR2-BICC1 fusion |
|---|---|
| Cancer: | Cholangiocarcinoma |
| Drug: | Lytgobi (futibatinib) (FGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
CT010 - Primary results of phase 2 FOENIX-CCA2: The irreversible FGFR1-4 inhibitor futibatinib in intrahepatic cholangiocarcinoma (iCCA) with FGFR2 fusions/rearrangements
Published date:
03/10/2021
Excerpt:
The study met its primary objective with a confirmed ORR of 41.7% (43/103). Responses were durable, with a median (m) DOR of 9.7 mo and 72% of responses ≥6 mo. DCR was 82.5%. mPFS was 9.0 mo; mOS was 21.7 mo, with a 12-mo OS rate of 72%...ORR was consistent in pts with FGFR2 fusions (43.8%) and other FGFR2 rearrangements (34.8%) and in pts with BICC1 (41.7%)...
Trial ID:
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:
Source:
Title:
Phase I, first-in-human study of futibatinib, a highly selective, irreversible FGFR1–4 inhibitor in patients with advanced solid tumors
Excerpt:
Secondary objectives included assessment of clinical PK, pharmacodynamics (PD), and preliminary antitumor activity of futibatinib….Confirmed PRs were observed in three patients with intrahepatic CCA (iCCA) harboring FGFR2–SORBS1 or FGFR2–BICC1 fusions (n = 2, 16-mg q.d. cohort; n = 1, 24-mg q.d. cohort)...
DOI:
https://doi.org/10.1016/j.annonc.2020.06.018
Trial ID:
