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| Gene | FGFR2 |
| Variant | fusion |
| Impact List | fusion |
| Protein Effect | unknown |
| Gene Variant Descriptions | FGFR2 fusion indicates a fusion of the FGFR2 gene, but the fusion partner is unknown. |
| Associated Drug Resistance | |
| Category Variants Paths |
FGFR2 mutant FGFR2 rearrange FGFR2 fusion |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| FGFR2 fusion | intrahepatic cholangiocarcinoma | sensitive | 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 | intrahepatic cholangiocarcinoma | sensitive | 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 | predicted - sensitive | 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 | 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 fusion | biliary tract cancer | sensitive | 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 | biliary tract cancer | sensitive | Futibatinib | Guideline | Actionable | Lytgobi (futibatinib) is included in the Pan-Asian Guidelines Adaptation (PAGA) for biliary tract cancer patients harboring FGFR2 fusions who have progressed after one or more lines of systemic therapy (PMID: 39232586; ESMO.org). | detail... 39232586 |
| FGFR2 fusion | cholangiocarcinoma | sensitive | 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 | 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 fusion | 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 fusion | Advanced Solid Tumor | no benefit | 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 fusion | Advanced Solid Tumor | no benefit | Zoligratinib | 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 |
| FGFR2 fusion | transitional cell carcinoma | predicted - sensitive | 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 | transitional cell carcinoma | predicted - sensitive | 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 | 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 fusion | 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 fusion | 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 fusion | 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). | 39864891 detail... |
| FGFR2 fusion | 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 fusion | 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 fusion | Advanced Solid Tumor | predicted - sensitive | 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 | 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 | 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 | Advanced Solid Tumor | predicted - sensitive | 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 | cholangiocarcinoma | predicted - sensitive | Lirafugratinib | Phase Ib/II | Actionable | In a Phase I/II trial (ReFocus), Lirafugratinib 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 | 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 fusion | Advanced Solid Tumor | predicted - sensitive | 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 | Erdafitinib | Phase II | Actionable | In a Phase II trial (RAGNAR), Balversa (erdafitinib) treatment resulted in an objective response rate of 56% (10/18), a disease control rate of 94%, 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 (PMID: 37541273; NCT04083976). | 37541273 |
| FGFR2 fusion | intrahepatic cholangiocarcinoma | predicted - sensitive | 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 | predicted - sensitive | 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 | 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 | 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 | 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 | gastroesophageal junction adenocarcinoma | predicted - sensitive | KIN-3248 | Phase I | Actionable | In a Phase I trial, KIN-3248 treatment demonstrated safety and preliminary activity in patients with advanced solid tumors harboring alterations in FGFR2 or FGFR3, with an objective response rate of 9.25% (5/54, 5 partial responses (PR)), including 2 PRs in patients with gastroesophageal jucntion cancer harboring a FGFR2 fusion (PMID: 38602417; NCT05242822). | 38602417 |
| FGFR2 fusion | cholangiocarcinoma | sensitive | Gemcitabine + Pemigatinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, treatment with the combination of Gemzar (gemcitabine) and Pemazyre (pemigatinib) synergistically inhibited viability of a cholangiocarcinoma cell line harboring an FGFR2 fusion in culture, and led to inhibition of tumor growth in a cell line xenograft model (PMID: 38801887). | 38801887 |
| FGFR2 fusion | biliary tract cancer | sensitive | Pemigatinib | Guideline | Actionable | Pemazyre (pemigatinib) is included in the Pan-Asian Guidelines Adaptation (PAGA) for biliary tract cancer patients harboring FGFR2 fusions who have progressed after one or more lines of systemic therapy (PMID: 39232586; ESMO.org). | detail... 39232586 |
| FGFR2 fusion | pancreatic adenocarcinoma | sensitive | Erdafitinib | Guideline | Actionable | Balversa (erdafitinib) is included in guidelines as subsequent therapy for patients with recurrent or locally advanced, metastatic pancreatic adenocarcinoma harboring an FGFR2 fusion with good (ECOG 0-1), intermediate (ECOG 2), or poor (ECOG 3) performance status (NCCN.org). | detail... |
| FGFR2 fusion | lung non-small cell carcinoma | sensitive | Erdafitinib | Guideline | Actionable | Balversa (erdafitinib) is included in guidelines for patients with metastatic non-small cell lung cancer harboring oncogenic or likely oncogenic FGFR alterations (NCCN.org). | detail... |
| FGFR2 fusion | breast cancer | sensitive | Erdafitinib | Guideline | Actionable | Balversa (erdafitinib) is included in guidelines for patients with stage IV (M1) breast cancer harboring FGFR fusion or mutations (NCCN.org). | detail... |
| FGFR2 fusion | salivary gland cancer | sensitive | Erdafitinib | Guideline | Actionable | Balversa (erdafitinib) is included in guidelines for patients with unresectable locally advanced, recurrent, or metastatic salivary gland tumors harboring FGFR mutations or fusions (category 2B) who received prior systemic therapy and have no alternative systemic therapy available (NCCN.org). | detail... |
| FGFR2 fusion | oral cavity cancer | sensitive | Erdafitinib | Guideline | Actionable | Balversa (erdafitinib) is included in guidelines as subsequent-line therapy (category 2B) for patients with oral cavity cancer harboring FGFR mutations or fusions and with no alternative options (NCCN.org). | detail... |
| FGFR2 fusion | oropharynx cancer | sensitive | Erdafitinib | Guideline | Actionable | Balversa (erdafitinib) is included in guidelines as subsequent-line therapy (category 2B) for patients with oropharynx cancer harboring FGFR mutations or fusions and with no alternative options (NCCN.org). | detail... |
| FGFR2 fusion | hypopharynx cancer | sensitive | Erdafitinib | Guideline | Actionable | Balversa (erdafitinib) is included in guidelines as subsequent-line therapy (category 2B) for patients with hypopharynx cancer harboring FGFR mutations or fusions and with no alternative options (NCCN.org). | detail... |
| FGFR2 fusion | supraglottis cancer | sensitive | Erdafitinib | Guideline | Actionable | Balversa (erdafitinib) is included in guidelines as subsequent-line therapy (category 2B) for patients with supraglottic larynx cancer harboring FGFR mutations or fusions and with no alternative options (NCCN.org). | detail... |
| FGFR2 fusion | glottis cancer | sensitive | Erdafitinib | Guideline | Actionable | Balversa (erdafitinib) is included in guidelines as subsequent-line therapy (category 2B) for patients with glottic larynx cancer harboring FGFR mutations or fusions and with no alternative options (NCCN.org). | detail... |
| FGFR2 fusion | ethmoid sinus cancer | sensitive | Erdafitinib | Guideline | Actionable | Balversa (erdafitinib) is included in guidelines as subsequent-line therapy (category 2B) for patients with ethmoid sinus cancer harboring FGFR mutations or fusions and with no alternative options (NCCN.org). | detail... |
| FGFR2 fusion | maxillary sinus cancer | sensitive | Erdafitinib | Guideline | Actionable | Balversa (erdafitinib) is included in guidelines as subsequent-line therapy (category 2B) for patients with maxillary sinus cancer harboring FGFR mutations or fusions and with no alternative options (NCCN.org). | detail... |