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Profile Name | FGFR2 rearrange |
Gene Variant Detail | |
Relevant Treatment Approaches |
Molecular Profile | Indication/Tumor Type | Response Type | Relevant Treatment Approaches | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|---|
FGFR2 rearrange | cholangiocarcinoma | sensitive | Pemigatinib | Guideline | Actionable | Pemazyre (pemigatinib) is included in guidelines as subsequent-line therapy for patients with cholangiocarcinoma harboring FGFR2 fusions or rearrangements (NCCN.org). | detail... | |
FGFR2 rearrange | cholangiocarcinoma | sensitive | Pemigatinib | FDA approved - Has Companion Diagnostic | Actionable | In a Phase II (FIGHT-202) trial, Pemazyre (pemigatinib) treatment resulted in an objective response in 35.5% (38/107, 3 complete response, 35 partial response) of patients with advanced cholangiocarcinoma harboring FGFR2 fusions or rearrangements, with a disease control rate of 82% (88/107), median time-to-response of 2.7 months, and a median progression-free survival of 6.9 months (PMID: 32203698; NCT02924376). | detail... 32203698 detail... | |
FGFR2 rearrange | cholangiocarcinoma | predicted - sensitive | Futibatinib | Phase I | Actionable | In a Phase I trial, TAS-120 treatment resulted in partial response in 2 patients with cholangiocarcinoma harboring FGFR2 rearrangements (Annals of Oncology, Volume 29, Issue suppl_5). | detail... | |
FGFR2 rearrange | intrahepatic cholangiocarcinoma | predicted - sensitive | Futibatinib | Case Reports/Case Series | Actionable | In a Phase II trial (FOENIX-CCA2), Futibatinib (TAS-120) demonstrated manageable toxicity profile, resulted in an objective response rate (ORR) of 37.3% (25/67), a median duration of response of 8.3 months, and a disease control rate of 82% in patients with intrahepatic cholangiocarcinoma harboring FGFR2 fusions (82%) or other rearrangements (18%), ORR was 44.4% (4/9) in patients harboring FGFR2 rearrangements (Annals of Oncology (2020) 31 (suppl_4): S261-S262; NCT02052778). | detail... |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT04093362 | Phase III | Futibatinib Cisplatin + Gemcitabine | Futibatinib Vs Gemcitabine-Cisplatin Chemotherapy as 1st-Line Treatment of Patients With Advanced Cholangiocarcinoma (CCA) Harboring FGFR2 Gene Rearrangements (FOENIX-CCA3) | Recruiting | ||
NCT04003623 | Phase II | Pemigatinib | Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208) | Recruiting | ||
NCT04189445 | Phase II | Futibatinib | Futibatinib in Patients With Specific FGFR Aberrations | Recruiting | ||
NCT04233567 | Phase II | Infigratinib | Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations | Recruiting | ||
NCT01975701 | Phase II | Infigratinib | A Phase 2 Study of BGJ398 in Patients With Recurrent GBM | Completed | ||
NCT04096417 | Phase II | Pemigatinib | Pemigatinib for the Treatment of Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations | Recruiting | ||
NCT02706691 | Phase II | Infigratinib | Pan FGFR Kinase Inhibitor BGJ398 in Treating Patients With FGFR1-3 Translocated, Mutated, or Amplified Recurrent Head and Neck Cancer | Terminated | ||
NCT04601857 | Phase II | Futibatinib + Pembrolizumab | Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma | Recruiting | ||
NCT01831726 | Phase II | Dovitinib | Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib | Completed | ||
NCT03834220 | Phase II | Debio 1347 | Basket Trial in Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3- (FUZE Clinical Trial) | Active, not recruiting | ||
NCT03656536 | Phase III | Pemigatinib Cisplatin + Gemcitabine | A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma - (FIGHT-302) | Recruiting |