Molecular Profile Detail

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Showing 1 to 26 of 26 entries

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
FGFR2 rearrange	cholangiocarcinoma	sensitive	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	intrahepatic cholangiocarcinoma	sensitive	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 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	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 rearrange	cholangiocarcinoma	sensitive	Futibatinib	Guideline	Actionable	Lytgobi (futibatinib) is included in guidelines as second or later-line therapy for patients with cholangiocarcinoma harboring FGFR2 fusions and rearrangements (PMID: 39864891; ESMO.org).	detail... 39864891
FGFR2 rearrange	cholangiocarcinoma	sensitive	Pemigatinib	Guideline	Actionable	Pemazyre (pemigatinib) is included in guidelines as second or later-line therapy for patients with cholangiocarcinoma harboring FGFR2 fusions or rearrangements (PMID: 39864891; ESMO.org).	detail... 39864891
FGFR2 rearrange	cholangiocarcinoma	sensitive	Erdafitinib	Guideline	Actionable	Balversa (erdafitinib) is included in guidelines as subsequent-line therapy for patients with cholangiocarcinoma harboring FGFR2 fusions or rearrangements (NCCN.org).	detail...
FGFR2 mutant	intrahepatic cholangiocarcinoma	predicted - sensitive	Derazantinib	Phase II	Actionable	In a Phase II trial (FIDES-01), Derazantinib (ARQ 087) treatment resulted in an objective response rate of 6.5%, a disease control rate of 58.1%, median progression-free survival of 8.3 months, and a median overall survival of 15.9 months in patients with intrahepatic cholangiocarcinoma harboring an FGFR2 mutation or amplification (Ann Oncol (2022) 33 (suppl_7): S19-S26; NCT03230318).	detail...
FGFR2 mutant	transitional cell carcinoma	predicted - sensitive	Cetrelimab + Erdafitinib	Phase II	Actionable	In a Phase II trial, the combination of Balversa (erdafitinib) and Cetrelimab (JNJ-63723283) treatment resulted in an overall response rate of 54.5% (6 complete responses), disease control rate of 79.5%, median duration of response of 11.10 months, median progression-free survival of 10.97 months, and a 12-month overall survival of 68% in patients with metastatic urothelial carcinoma harboring FGFR mutations (J Clin Oncol 41, 2023 (suppl 16; abstr 4504); NCT03473743).	detail...
FGFR2 mutant	Advanced Solid Tumor	predicted - sensitive	Sunitinib	Phase II	Actionable	In a Phase II trial (TAPUR), Sutent (sunitinib) treatment resulted in a disease control rate of 39% (11/28) and an objective response rate of 11% (3/28, all partial responses (PR)) in advanced solid tumor patients harboring FGFR2 alterations including mutation (n=19), amplification (amp) (n=2), fusion (n=2), mutation and amp (n=4), or fusion, mutation, and amp (n=1), with 2 PR in lung cancer and 1 PR in uterine cancer harboring FGFR2 mutations (Cancer Res (2025) 85 (8_Supplement_2): CT226).	detail...
FGFR2 rearrange	cholangiocarcinoma	predicted - sensitive	Infigratinib	Phase II	Actionable	In a Phase II trial, 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...
FGFR2 mutant	Advanced Solid Tumor	predicted - sensitive	Zoligratinib	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 mutant	cholangiocarcinoma	predicted - sensitive	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 mutant	Advanced Solid Tumor	predicted - sensitive	ICP-192	Phase I	Actionable	In a Phase I trial, ICP-192 (gunagratinib) was well-tolerated, and resulted in an overall response rate or 33.3% (4/12, 1 complete response, 3 partial response) and a disease control rate of 91.7% (11/12) in patients with advanced solid tumors harboring FGF/FGFR gene aberrations (J Clin Oncol 39, 2021 (suppl 15; abstr 4092); NCT03758664).	detail...
FGFR2 rearrange	cholangiocarcinoma	sensitive	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 mutant	cholangiocarcinoma	sensitive	Infigratinib	Case Reports/Case Series	Actionable	In a Phase I trial, a patient with cholangiocarcinoma harboring an FGFR2 mutation demonstrated a decreased tumor burden when treated with Truseltiq (infigratinib) (PMID: 27870574).	27870574
FGFR2 mutant	breast cancer	no benefit	Sunitinib	Case Reports/Case Series	Actionable	In a Phase II trial (TAPUR), Sutent (sunitinib) treatment did not meet the predetermined efficacy criteria in metastatic breast cancer patients with FGFR2 amplification (n=2), FGFR2 mutation (including FGFR2 rearrangement) (n=6), or both (n=2), resulting in no objective responses or stable disease of at least 16 weeks, median progression-free survival of 8 weeks, and a median overall survival of 22 weeks (PMID: 38354330; NCT02693535).	38354330
FGFR2 mutant	Advanced Solid Tumor	predicted - sensitive	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 rearrange	cholangiocarcinoma	sensitive	Futibatinib	Case Reports/Case Series	Actionable	In a Phase I trial, Lytgobi (futibatinib) treatment resulted in partial response in 2 patients with cholangiocarcinoma harboring FGFR2 rearrangements (Annals of Oncology, Volume 29, Issue suppl_5).	detail...
FGFR2 rearrange	pancreatic ductal adenocarcinoma	predicted - sensitive	Erdafitinib	Case Reports/Case Series	Actionable	In a clinical case study, Balversa (erdafitinib) treatment resulted in decrease in the pulmonary lesions, symptom improvement, and decreased CA 19-9 levels with treatment continuing at least 12 months in a patient with pancreatic ductal adenocarcinoma harboring an FGFR2 rearrangement (PMID: 36240849).	36240849
FGFR2 rearrange	breast cancer	no benefit	Sunitinib	Case Reports/Case Series	Actionable	In a Phase II trial (TAPUR), Sutent (sunitinib) treatment did not meet the predetermined efficacy criteria in metastatic breast cancer patients with FGFR2 amplification (n=2), FGFR2 mutation (including FGFR2 rearrangement) (n=6), or both (n=2), resulting in no objective responses or stable disease of at least 16 weeks, median progression-free survival of 8 weeks, and a median overall survival of 22 weeks (PMID: 38354330; NCT02693535).	38354330
FGFR2 rearrange	Her2-receptor negative breast cancer	predicted - sensitive	Tinengotinib	Case Reports/Case Series	Actionable	In a Phase I trial, Tinengotinib (TT-00420) treatment was well tolerated and resulted in stable disease in 53.3% (23/43) and partial response in 16.3% (7/43) of patients with advanced solid tumors, including a partial response in a patient with hormone receptor-positive, ERBB2 (Her2)-negative breast cancer harboring an FGFR2 rearrangement (PMID: 38297981; NCT03654547).	38297981
FGFR2 rearrange	cholangiocarcinoma	sensitive	Erdafitinib	Case Reports/Case Series	Actionable	In a Phase II trial, Balversa (erdafitinib) treatment resulted in a confirmed objective response rate (ORR) of 40.9% (9/22, 1 complete, 8 partial responses), a median progression-free survival of 5.6 months, and median overall survival of 25.8 months in patients with cholangiocarcinoma harboring an FGFR rearrangement or FGFR short variant, with an ORR of 57.1% (8/14) with FGFR rearrangement and 12.5% (1/8) with FGFR short variant (PMID: 39138436; NCT02699606).	39138436
FGFR2 mutant	Advanced Solid Tumor	sensitive	Pemigatinib	Preclinical - Cell culture	Actionable	In a preclinical study, a variety of cancer cell lines harboring mutations in FGFR1, FGFR2, and/or FGFR3 demonstrated sensitivity to Pemazyre (pemigatinib) in culture and in cell line xenograft models, resulting in inhibition of tumor growth (Cancer Res 2015;75(15 Suppl):Abstract nr 771).	detail...
FGFR2 mutant	endometrial cancer	sensitive	PRN1371	Preclinical - Cell culture	Actionable	In a preclinical study, PRN1371 inhibited proliferation of endometrial cancer cells harboring FGFR2 mutations in culture (AACR; Cancer Res 2016;76(14 Suppl):Abstract nr 1249).	detail...
FGFR2 mutant	endometrial cancer	sensitive	Infigratinib	Preclinical	Actionable	In a preclinical study, Truseltiq (infigratinib) inhibited the growth of FGFR2-mutated endometrial cancer cells in vitro and in xenograft models (PMID: 23443805).	23443805

Showing 1 to 26 of 26 entries

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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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