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Association details:
| Biomarker: | FGFR2 fusion |
|---|---|
| Cancer: | Cholangiocarcinoma |
| Drug: | derazantinib (ARQ 087) (FGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma (FIDES-01)
Excerpt:
...Substudy 1: FGFR2 gene fusion status based on the following assessments...Substudy 2: FGFR2 mutation status based on local NGS testing performed or commissioned by the respective study site using a validated test. For NGS testing, no central laboratory will be established for the purpose of Substudy 2...
Trial ID:
Source:
Title:
59P - Efficacy of derazantinib in intrahepatic cholangiocarcinoma (iCCA) patients with FGFR2 fusions, mutations or amplifications
Published date:
09/05/2022
Excerpt:
In pts with FGFR2F, confirmed ORR was 21.4% (95% CI 13.9, 30.5), DCR 75.7% (95% CI 66.3, 83.6), mPFS 8.0 mo (95% CI 5.5, 8.3) and mOS 17.2 mo (95% CI 12.5, 22.4).In pts with FGFR2MA, confirmed ORR was 6.5% (95% CI 0.8, 21.4), DCR 58.1% (95% CI 39.1, 75.5), mPFS 8.3 mo (95% CI 1.9, 16.7) and mOS 15.9 mo (95% CI 8.4, NE).Derazantinib results in meaningful clinical benefit for pts with FGFR2 genetic aberrations including FGFR2F and FGFR2MA. Derazantinib-related toxicities were limited: PPE, stomatitis, retinal or nail toxicity were infrequent in the study population.
Source:
Title:
47P - Derazantinib for patients with intrahepatic cholangiocarcinoma harboring FGFR2 fusions/rearrangements: Primary results from the phase II study FIDES-01
Published date:
09/13/2021
Excerpt:
Derazantinib showed clinically meaningful efficacy with durable objective responses, and a manageable safety profile with a particularly low incidence of drug-related hand-foot syndrome, stomatitis, retinal or nail toxicity in pts with iCCA harboring FGFR2fus.
Trial ID:
Source:
Title:
Basilea provides updates on efficacy data with derazantinib in bile duct cancer and on ongoing clinical programs in urothelial and gastric cancer
Published date:
05/31/2021
Excerpt:
Basilea Pharmaceutica Ltd...today reported updated response data from cohort 1 of the FIDES-01 study. The cohort is assessing the anti-tumor efficacy of...derazantinib, in patients with FGFR2 gene fusion-positive intrahepatic cholangiocarcinoma (iCCA)...shows that the objective response rate (ORR) increased from 20.4% to 21.4%, the disease control rate (DCR) from 72.8% to 74.8% and the median progression-free survival (PFS) from 6.6 to 7.8 months...
Trial ID:
Source:
Title:
Basilea reports positive topline results from phase 2 study FIDES-01 for derazantinib in FGFR2 gene fusion-positive patients with bile duct cancer (iCCA)
Published date:
02/10/2021
Excerpt:
In total, 103 patients with iCCA and FGFR2 gene fusions...The objective response rate (ORR) is 20.4% based on 21 patients with a confirmed partial response...The disease control rate (DCR), reflecting the proportion of patients with a partial response or with stable disease, was 72.8%. The median progression-free survival (PFS) in patients was 6.6 months.
Trial ID:
Source:
Title:
Derazantinib (ARQ 087) in advanced or inoperable FGFR2 gene fusion-positive intrahepatic cholangiocarcinoma
Excerpt:
Derazantinib demonstrated encouraging anti-tumour activity and a manageable safety profile in patients with advanced, unresectable iCCA with FGFR2 fusion who progressed after chemotherapy.
DOI:
10.1038/s41416-018-0334-0
Trial ID:
Source:
Title:
ARQ 087, an Oral Pan- Fibroblast Growth Factor Receptor (FGFR) Inhibitor, in Patients with Advanced and/or Metastatic Intrahepatic Cholangiocarcinoma (iCCA)
Excerpt:
Patient 0088 with iCCA (FGFR2 fusion) whose disease progressed after one prior regimen of systemic therapy had a partial response: 44% decrease in tumor burden, completed 4 cycles.... ARQ 087 has a potent biochemical activity against the FGFR2 kinase and has demonstrated in vitro efficacy in models with FGFR2 fusion.
