Molecular Profile Detail

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Profile Name FGFR2 fusion
Gene Variant Detail

FGFR2 fusion (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 fusion intrahepatic cholangiocarcinoma sensitive FGFR2 Inhibitor Derazantinib Phase I Actionable In a Phase Ib/II trial, Derazantinib (ARQ 087) treatment resulted in an overall response rate of 20.7% (6/29), a disease control rate of 82.8% (24/29), and a median progression-free survival of 5.7 months in patients with intrahepatic cholangiocarcinoma harboring FGFR2 fusions (PMID: 30420614; NCT01752920). 30420614
FGFR2 fusion cholangiocarcinoma sensitive FGFR Inhibitor (Pan) Infigratinib Case Reports/Case Series Actionable In a Phase I trial, two patients with cholangiocarcinoma harboring FGFR2 fusions demonstrated a decreased tumor burden when treated with Truseltiq (infigratinib) (PMID: 27870574). 27870574
FGFR2 fusion biliary tract cancer predicted - sensitive FGFR Inhibitor (Pan) Futibatinib Phase I Actionable In a Phase I trial, Lytgobi (futibatinib) treatment resulted in stable disease over 24 weeks in two biliary tract cancer patients harboring FGFR2 fusions (Ann Oncol 2017, Vol 28, Suppl 5, Abstract # 372PD). detail...
FGFR2 fusion cholangiocarcinoma sensitive FGFR Inhibitor (Pan) Futibatinib Phase I Actionable In a Phase I trial, Lytgobi (futibatinib) treatment resulted in an objective response rate of 25% (7/28, 7 partial responses) in patients with cholangiocarcinoma harboring FGFR2 fusions, with 71% of patients experienced tumor shrinkage, 54% (15/28) achieved stable disease (Annals of Oncology, Volume 29, Issue suppl_5). detail...
FGFR2 fusion Advanced Solid Tumor predicted - sensitive FGFR2 Inhibitor Debio 1347 Phase I Actionable In a Phase I trial, Debio 1347 treatment resulted in partial response in 10.5% (6/57) and stable disease in 28.1% (16/57) of patients with advanced solid tumors harboring genomic alterations of FGFR1/2/3, including amplifications, fusions, and mutations (PMID: 30745300; NCT01948297). 30745300
FGFR2 fusion transitional cell carcinoma predicted - sensitive FGFR Inhibitor (Pan) Erdafitinib Phase I Actionable In a Phase I trial, Balversa (erdafitinib) treatment resulted in an objective response rate of 46% (12/26) in patients with urothelial carcinoma harboring FGFR genomic alterations, including 17 with FGFR3 mutations, and 11 with FGFR2 and/or FGFR3 fusions (PMID: 31088831; NCT01703481). 31088831
FGFR2 fusion cholangiocarcinoma predicted - sensitive FGFR Inhibitor (Pan) Erdafitinib Phase I Actionable In a Phase I trial, Balversa (erdafitinib) treatment resulted in an objective response rate of 27% (3/11) in patients with cholangiocarcinoma harboring FGFR genomic alterations, including 1 with FGFR2 mutation, 2 with FGFR3 mutations, and 8 with FGFR2 fusions (PMID: 31088831; NCT01703481). 31088831
FGFR2 fusion 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 fusion 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 fusion 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 fusion intrahepatic cholangiocarcinoma sensitive FGFR Inhibitor (Pan) Futibatinib FDA approved Actionable In a Phase II trial (FOENIX-CCA2) that supported FDA approval, Lytgobi (futibatinib) demonstrated a manageable toxicity profile and resulted in an objective response rate of 41.7% (43/103), a disease control rate of 82.5% in patients with advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 fusions or other rearrangements, with a median progression-free survival of 8.9 mo and median overall survival of 20.0 mo (J Clin Oncol 40, no. 16_suppl (June 01, 2022) 4009; NCT02052778). detail... detail...
FGFR2 fusion Advanced Solid Tumor predicted - sensitive FGFR Inhibitor (Pan) Futibatinib Phase I Actionable In a Phase I trial (FOENIX-101), Lytgobi (futibatinib) treatment demonstrated manageable safety profile, and resulted in a partial response in 6% (5/86) and stable disease in 48% (41/86) of patients with advanced solid tumors harboring FGF/FGFR aberrations, among whom 20% (15/74) harbored FGFR2 fusions (PMID: 32622884; NCT02052778). 32622884
FGFR2 fusion cholangiocarcinoma predicted - sensitive FGFR Inhibitor (Pan) ICP-192 Case Reports/Case Series Actionable In a Phase I trial, ICP-192 (gunagratinib) treatment resulted in a complete response in a patient with cholangiocarcinoma harboring FGFR2 fusion (J Clin Oncol 39, 2021 (suppl 15; abstr 4092); NCT03758664). detail...
FGFR2 fusion stomach cancer predicted - sensitive FGFR2 Inhibitor RLY-4008 Preclinical - Cell line xenograft Actionable In a preclinical study, RLY-4008 treatment led to tumor regression in a cell line xenograft model of gastric cancer harboring an FGFR2 fusion (Cancer Res 2021;81(13_Suppl):Abstract nr 1455). detail...
FGFR2 fusion lung cancer predicted - sensitive FGFR2 Inhibitor RLY-4008 Preclinical - Cell line xenograft Actionable In a preclinical study, RLY-4008 treatment led to tumor regression in a cell line xenograft model of lung cancer harboring an FGFR2 fusion (Cancer Res 2021;81(13_Suppl):Abstract nr 1455). detail...
FGFR2 fusion 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...
FGFR2 fusion Advanced Solid Tumor predicted - sensitive FGFR2 Inhibitor Pemigatinib Case Reports/Case Series Actionable In a Phase I trial (FIGHT-101), Pemazyre (pemigatinib) treatment led to an objective response rate of 25% (5/20, all partial responses) in patients harboring FGFR rearrangements, with all 5 partial responses in patients with FGFR2 fusions, stable disease in 50% (10/20) of patients, and a median progression-free survival of 5.7 months (PMID: 35176457; NCT02393248). 35176457
FGFR2 fusion bladder urothelial carcinoma sensitive FGFR Inhibitor (Pan) Erdafitinib Guideline Actionable Balversa (erdafitinib) is included in guidelines for patients with advanced or metastatic bladder urothelial carcinoma harboring FGFR alterations (PMID: 34861372; ESMO.org). detail... 34861372
FGFR2 fusion cholangiocarcinoma predicted - sensitive FGFR2 Inhibitor RLY-4008 Phase Ib/II Actionable In a Phase I/II trial (ReFocus), RLY-4008 treatment resulted in an objective response rate (ORR) of 88% (15/17), a confirmed ORR of 82.4% (14/17), and a disease control rate of 100% (17/17) at the recommended Phase II dose, and an ORR of 63.2% (24/38) at all dose levels in patients with FGFR inhibitor-naive cholangiocarcinoma harboring FGFR2 fusions or rearrangements (Ann Oncol (2022) 33 (suppl_7): S808-S869; NCT04526106). detail...
FGFR2 fusion intrahepatic cholangiocarcinoma sensitive FGFR2 Inhibitor Derazantinib Phase II Actionable In a Phase II trial (FIDES-01), Derazantinib (ARQ 087) treatment resulted in an objective response rate of 21.4%, a disease control rate of 75.7%, median progression-free survival of 8.0 months, and a median overall survival of 17.2 months in patients with intrahepatic cholangiocarcinoma harboring an FGFR2 fusion (Ann Oncol (2022) 33 (suppl_7): S19-S26; NCT03230318). detail...
FGFR2 fusion cholangiocarcinoma sensitive FGFR Inhibitor (Pan) Futibatinib Guideline Actionable Lytgobi (futibatinib) is included in guidelines as subsequent-line therapy (category 2A) for patients with cholangiocarcinoma harboring an FGFR2 fusion or rearrangement (NCCN.org). detail...