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Association details:
| Biomarker: | FGFR2 amplification |
|---|---|
| Cancer: | Cholangiocarcinoma |
| Drug: | derazantinib (ARQ 087) (FGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A Phase 1/2 Study of ARQ 087 in Adult Subjects with Advanced Solid Tumors with FGFR Genetic Alterations Studio di fase I/II con ARQ 087 in soggetti adulti con Tumori solidi in stadio avanzato che presentino alterazione genetica FGFR
Excerpt:
...-All subjects eligible for enrollment in the Food-effect Cohort must have the following tumor types: luminal breast A or B, endometrial, urothelial, gastric, or lung cancer with known and/or confirmed FGFR1-3 high level amplification, mutation or gene rearrangement (fusion, translocation), or adrenocortical carcinoma, cholangiocarcinoma, or sarcomas, independent from FGFR1-3 mutation status -All subjects eligible for enrollment in the Food-effect Cohort should agree to and be eligible for paired biopsy 7. ...
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.
Trial ID:
Source:
Title:
Efficacy of derazantinib in intrahepatic cholangiocarcinoma patients with FGFR2 mutations or amplifications: Interim results from the phase 2 study FIDES-01
Published date:
01/18/2022
Excerpt:
Study FIDES-01 enrolls in a dedicated cohort pts with FGFR2M/A+ advanced iCCA who received previous chemotherapy. Pts receive 300 mg derazantinib daily until disease progression, death or intolerance. In 23 pts included in this interim analysis for efficacy, the best overall response (investigator assessment) was confirmed partial response in two (8.7%) and stable disease in additional 15 pts (65.2%), resulting in a disease control rate of 73.9% (95% CI, 51.6–89.8). Using Kaplan-Meier analyses, the median PFS was 7.3 months (95%CI, 3.5–16.7) and the probability of being progression-free at 3 months and at 6 months were 76.3% (95%CI, 51.9–89.4) and 50.3% (95%CI, 21.7–73.4), respectively. Clinically meaningful anti-tumor efficacy was observed across all types of genetic aberrations. The safety profile of derazantinib in FGFR2M/A+ iCCA pts was consistent with that previously reported for FGFR2F+ iCCA pts...derazantinib treatment provides clinical benefit to pts with advanced iCCA harboring FGFR2M/A who progressed after at least one line of standard chemotherapy.
DOI:
10.1200/JCO.2022.40.4_suppl.427
Trial ID:
Source:
Title:
Basilea reports positive interim results from phase 2 study FIDES-01 for derazantinib in FGFR2 gene mutation- or amplification-positive patients with bile duct cancer (iCCA)
Published date:
03/24/2021
Excerpt:
...cohort 2 is enrolling iCCA patients with FGFR2 gene mutations or amplifications...The interim analysis of cohort 2 is based on 14 evaluable patients who had at least one post-baseline tumor assessment. The pre-specified criterion that at least 8 patients met the primary endpoint of obtaining progression-free survival (PFS) of at least 3 months was successfully achieved.
Trial ID:
Source:
Title:
Efficacy of derazantinib in intrahepatic cholangiocarcinoma patients with FGFR2 mutations or amplifications: Pooled analysis of clinical trials and early access programs
Published date:
10/10/2020
Excerpt:
Pooled interim analysis of FGFR2M/A+ iCCA patients treated with DZB on studies ARQ 087-101, FIDES-01 and early access programs (EAP). Within the limitations of small cohort sizes, DZB demonstrated antitumor efficacy in FGFR2M/A+ iCCA patients across three independent clinical data sets.
