Molecular Profile Detail

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Profile Name FGFR2 rearrange
Gene Variant Detail

FGFR2 rearrange (unknown)

Relevant Treatment Approaches FGFR Inhibitor (Pan) FGFR2 Inhibitor

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Molecular Profile Indication/Tumor Type Response Type Relevant Treatment Approaches Therapy Name Approval Status Evidence Type Efficacy Evidence References
FGFR2 rearrange cholangiocarcinoma predicted - sensitive FGFR Inhibitor (Pan) 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 FGFR Inhibitor (Pan) 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...
FGFR2 rearrange cholangiocarcinoma sensitive FGFR2 Inhibitor 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 FGFR2 Inhibitor Pemigatinib FDA approved - On 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 sensitive FGFR Inhibitor (Pan) Infigratinib FDA approved - On Companion Diagnostic Actionable In a Phase II trial that supported FDA approval, Truseltiq (infigratinib) treatment demonstrated manageable toxicity, resulted in an objective response rate of 23.1% (25/108, 1 complete response, 24 partial responses) in patients with previously treated advanced cholangiocarcinoma harboring an FGFR2 fusion or rearrangement, with a median duration of response of 5.0 months and a median progression-free survival of 7.3 months (J Clin Oncol 39, no. 3_suppl (January 20, 2021) 265-265; NCT02150967). detail... detail... detail...
FGFR2 rearrange cholangiocarcinoma sensitive FGFR Inhibitor (Pan) Infigratinib Guideline Actionable Truseltiq (infigratinib) is included in guidelines as a subsequent-line therapy for patients with cholangiocarcinoma harboring an FGFR2 fusion or rearrangement (NCCN.org). detail...
Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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 USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT 11
NCT04294277 Phase II Pemigatinib Safety and Efficacy of Pemigatinib in Patients With High-risk Urothelial Cancer After Radical Surgery (PEGASUS) Active, not recruiting ITA 0
NCT04507503 Expanded access Futibatinib Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements Available USA 0
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 USA 0
NCT03611868 Phase Ib/II APG-115 + Pembrolizumab A Study of APG-115 in Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors Recruiting USA 1
NCT04003623 Phase II Pemigatinib Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208) Terminated USA 0
NCT03834220 Phase II Debio 1347 Basket Trial in Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3- (FUZE Clinical Trial) Terminated USA | FRA | ESP | AUT 19
NCT04923126 Phase Ib/II PD-0325901 SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma Recruiting USA 0
NCT05216120 Phase II Pemigatinib Pemigatinib in Subjects With Adenosquamous Carcinoma of the Pancreas Not yet recruiting USA 0
NCT01831726 Phase II Dovitinib Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib Completed USA 0
NCT05174650 Phase II Atezolizumab + Derazantinib Treatment of Atezolizumab and Derazantinib in Patients With Advanced iCCA With FGFR2 Fusions/Rearrangements Recruiting DEU 0
NCT01975701 Phase II Infigratinib A Phase 2 Study of BGJ398 in Patients With Recurrent GBM Completed USA | ESP | BEL 3
NCT05267106 Phase II Pemigatinib Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations (FIGHT-209) Recruiting USA | ITA | FRA | ESP | DEU 4
NCT04189445 Phase II Futibatinib Futibatinib in Patients With Specific FGFR Aberrations Recruiting USA | ITA | FRA | ESP | DEU | BEL 9
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 USA | ITA | FRA | ESP | DEU | BEL 14
NCT04233567 Phase II Infigratinib Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations Recruiting USA 0
NCT04601857 Phase II Futibatinib + Pembrolizumab Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma Recruiting USA | FRA | ESP 0
NCT04096417 Phase II Pemigatinib Pemigatinib for the Treatment of Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations Active, not recruiting USA 0