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 Case Reports/Case Series 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 no benefit 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 safety and resulted in an objective response rate of 42% (43/103, 1 complete response, 42 partial responses), disease control rate of 83% (85/103), median duration of response of 9.7 mo, median progression-free survival of 9.0 mo, and median overall survival of 21.7 mo in patients with advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements (PMID: 36652354; NCT02052778). detail... 36652354
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 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 radiographic tumor reductions in 64% (74/116) and partial responses/stable disease in 72% (83/116) of patients with advanced solid tumors harboring FGFR2 alterations, and an objective response rate of 52% (13/25) and a disease control rate of 88% (22/25) in FGFR inhibitor-naive cholangiocarcinoma patients harboring FGFR2 fusions or rearrangements (J Clin Oncol 41, 2023 (suppl 16; abstr 4009); 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...
FGFR2 fusion cholangiocarcinoma sensitive FGFR2 Inhibitor Pemigatinib Guideline Actionable Pemazyre (pemigatinib) is included in guidelines as second or later-line therapy for patients with cholangiocarcinoma harboring FGFR2 fusions (PMID: 36372281; ESMO.org). 36372281 detail...
FGFR2 fusion cholangiocarcinoma sensitive FGFR Inhibitor (Pan) Futibatinib Guideline Actionable Lytgobi (futibatinib) is included in guidelines as second or later-line therapy for patients with cholangiocarcinoma harboring FGFR2 fusions (PMID: 36372281; ESMO.org). 36372281 detail...
FGFR2 fusion cholangiocarcinoma sensitive FGFR Inhibitor (Pan) Infigratinib Guideline Actionable Truseltiq (infigratinib) is included in guidelines as second or later-line therapy for patients with cholangiocarcinoma harboring FGFR2 fusions (PMID: 36372281; ESMO.org). 36372281 detail...
FGFR2 fusion Advanced Solid Tumor predicted - sensitive FGFR Inhibitor (Pan) Erdafitinib Phase II Actionable In a Phase II trial (RAGNAR), Balversa (erdafitinib) treatment resulted in an objective response rate of 29.5% (64/217, 6 complete and 58 partial responses), a disease control rate of 74%, clinical benefit rate of 46%, a median duration of response of 6.9 months, median progression-free survival of 4.2 months, and median overall survival of 10.7 months in patients with advanced solid tumors harboring FGFR1, FGFR2, or FGFR3 mutations or fusions (PMID: 37541273; NCT04083976). 37541273
FGFR2 fusion pancreatic cancer predicted - sensitive FGFR Inhibitor (Pan) Erdafitinib Phase II Actionable In a Phase II trial (RAGNAR), Balversa (erdafitinib) treatment resulted in an objective response rate of 55.6%, a disease control rate of 94.4%, median duration of response of 7.1 months, median progression-free survival of 7.0 months, and median overall survival of 19.7 months in patients with pancreatic cancer harboring FGFR1 (n=4) or FGFR2 (n=14) fusions (Ann Oncol (2023) 34 (suppl_2): S898; NCT04083976). detail...
FGFR2 fusion intrahepatic cholangiocarcinoma predicted - sensitive FGFR Inhibitor (Pan) HMPL-453 Phase II Actionable In a Phase II trial, HMPL-453 treatment demonstrated acceptable toxicity in patients with advanced intrahepatic cholangiocarcinoma harboring FGFR2 fusions, and resulted in an overall response rate of 31.8% (7/22, all partial responses) and disease control rate (DCR) of 86.4% (19/22), with stable disease in 12 patients, with an objective response rate of 50% and DCR of 90% at a dose of 300mg (n=10) (J Clin Oncol 41, 2023 (suppl 16; abstr e16118); NCT04353375). detail...
FGFR2 fusion cholangiocarcinoma sensitive FGFR2 Inhibitor Pemigatinib Clinical Study Actionable In a retrospective analysis, Pemazyre (pemigatinib) demonstrated safety and efficacy in real-world patients with previously treated, locally advanced or metastatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements, resulting in an objective response rate of 45.8% (33/72, 2 complete and 31 partial responses), disease control rate of 84.7% (61/72), with median duration of response of 7 mo, median progression-free survival of 8.7 mo, and median overall survival of 17.1 mo (PMID: 38340384). 38340384
FGFR2 fusion cholangiocarcinoma predicted - sensitive FGFR2 Inhibitor E7090 Phase II Actionable In a Phase II trial, E7090 demonstrated safety and preliminary activity in patients with cholangiocarcinoma harboring FGFR2 fusions, resulting in an objective response rate of 30% (19/63, 19 partial responses), disease control rate of 79% (50/63), clinical benefit rate of 51% (32/63), with a median time to response of 1.87 mo, median duration of response of 5.6 mo, median progression-free survival of 5.4 mo, and a median overall survival of 13.1 mo (J Clin Oncol, 42, no. 3_suppl (2024) 471; NCT04238715). detail...
FGFR2 fusion intrahepatic cholangiocarcinoma predicted - sensitive FGFR2 Inhibitor 3HP-2827 Preclinical - Pdx Actionable In a preclinical study, 3HP-2827 treatment demonstrated antitumor activity and induced tumor regression in a patient-derived xenograft (PDX) model of intrahepatic cholangiocarcinoma harboring an FGFR2 fusion (Cancer Res (2024) 84 (6_Supplement): 1965). detail...
FGFR2 fusion stomach cancer predicted - sensitive FGFR2 Inhibitor 3HP-2827 Preclinical - Pdx Actionable In a preclinical study, 3HP-2827 treatment demonstrated antitumor activity in a patient-derived xenograft (PDX) model of gastric cancer harboring an FGFR2 fusion (Cancer Res (2024) 84 (6_Supplement): 1965). detail...
FGFR2 fusion lung non-small cell carcinoma predicted - sensitive FGFR2 Inhibitor ABSK061 Case Reports/Case Series Actionable In a Phase I trial, ABSK061 treatment resulted in a partial response in a patient with non-small cell lung cancer harboring an FGFR2 fusion (ESMO Open 9 (2024): 102274); NCT05244551). detail...
FGFR2 fusion Advanced Solid Tumor predicted - sensitive FGFR Inhibitor (Pan) Erdafitinib Case Reports/Case Series Actionable In a Phase II trial (MATCH), Balversa (erdafitinib) treatment resulted in an objective response rate of 16% (4/25), median progression-free survival of 3.6 months, and median overall survival of 11.0 months in patients with advanced solid tumors harboring FGFR1, FGFR2, or FGFR3 mutations or fusions (PMID: 38603650; NCT02465060). 38603650
FGFR2 fusion transitional cell carcinoma predicted - sensitive FGFR Inhibitor (Pan) Erdafitinib Case Reports/Case Series Actionable In a Phase II trial (BCL2001), Balversa (erdafitinib) treatment resulted in an objective response rate of 40% (40/99, 3 complete response, 37 partial response) and a disease control rate of 80% in patients with metastatic or unresectable urothelial carcinoma harboring FGFR alterations, including 5 patients harboring FGFR2 fusions (PMID: 31340094; NCT02365597). 31340094
FGFR2 fusion Advanced Solid Tumor predicted - sensitive FGFR2 Inhibitor Pemigatinib Phase II Actionable In a Phase II trial (FIGHT-207), Pemazyre (pemigatinib) treatment demonstrated safety in previously treated patients with advanced solid tumors harboring a fusion in FGFR1, FGFR2, or FGFR3, and resulted in an objective response rate of 26.5% (13/49, 1 complete and 12 partial responses), with a median duration of response of 7.8 months, a clinical benefit rate of 28.6%, a median progression-free survival of 4.5 months, and a median overall survival of 17.5 months (PMID: 38710951; NCT03822117). 38710951
FGFR2 fusion Advanced Solid Tumor no benefit FGFR2 Inhibitor Debio 1347 Phase II Actionable In a Phase II trial (FUZE), Debio 1347 treatment demonstrated manageable toxicity but limited efficacy in patients with advanced solid tumors harboring a fusion in FGFR1, FGFR2, or FGFR3, resulting in an objective response rate of 5% (3/58, all partial responses), with stable disease in in 45% (26/58) of patients, and a median progression-free survival of 3.55 months at a median follow-up of 3.6 months, and further enrollment to the trial was terminated due to lack of efficacy (PMID: 38771739; NCT03834220). 38771739