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Association details:
| Biomarker: | FGFR2 amplification |
|---|---|
| Cancer: | Gastric Cancer |
| Drug: | Lytgobi (futibatinib) (FGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Futibatinib in Patients With Specific FGFR Aberrations
Excerpt:
...Histologically-confirmed, locally-advanced, advanced, or metastatic gastric or gastroesophageal junction cancer harboring a FGFR2 amplification....
Trial ID:
Source:
Title:
Futibatinib, an irreversible FGFR1–4 inhibitor, in patients with advanced solid tumors harboring FGF/FGFR aberrations: a phase I dose-expansion study
Published date:
09/22/2021
Excerpt:
Among the 170 patients who received futibatinib 20 mg QD, 10.6% experienced PRs, and 38.2% experienced SD...In the gastric cancer cohort, the ORR was 22.2% (95% CI, 2.8%–60.0%): PRs were seen in 2 of 9 patients, 1 with an FGFR2 amplification (DOR, 3.5 months) and the other with an FGFR3-TACC3 fusion (DOR, 5.4 months). Three patients experienced SD (including 2 patientswith unconfirmed PRs), and the DCR was 55.6% (95% CI, 21.2%–86.3%).
DOI:
10.1158/2159-8290.CD-21-0697
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...All 3 GC pts with confirmed PRs (tumor shrinkage: 59, 60, and 73%) had FGFR2 amplification (amp) with copy number value (CNV) >10. In the subset of GC pts with FGFR2 amp CNV >10 receiving 20 mg QD (N=9), ORR was 33% with a disease control rate of 44%.
Source:
Title:
544P - Phase I study of the irreversible FGFR inhibitor (i) futibatinib (FBN; TAS-120) in Japanese patients (pts) with advanced (adv) solid tumours
Published date:
09/14/2020
Excerpt:
FBN showed manageable safety and preliminary efficacy in Japanese pts with adv solid tumors...partial responses were observed in pts with gastric (n=2; tumor shrinkages of 59% and 70%) and breast cancer (n=1; tumor shrinkage, 37%) harboring FGFR2 amplifications.
Source:
Title:
Abstract 564: Futibatinib (TAS-120) plus chemotherapy demonstrates a synergistic effect across various FGFR-deregulated cancer cell lines and xenograft models
Published date:
05/15/2020
Excerpt:
A synergistic effect on cell growth inhibition was observed with futibatinib plus chemo in SNU-16 cells (CIs at ED90 were 0.50 [5-FU], 0.71 [paclitaxel], 0.76 [cisplatin], and 0.29 [gemcitabine])...In xenograft models, vs monotherapy, a significant reduction (P<0.01) in RTV occurred with futibatinib plus S-1, paclitaxel (Table), or cisplatin and a numerically greater reduction with futibatinib plus gemcitabine.
Secondary therapy:
gemcitabine; 5-fluorouracil; bisphosphonate bound paclitaxel; cisplatin; gimeracil/oteracil/tegafur
DOI:
10.1158/1538-7445.AM2020-564
