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| Profile Name | FGFR2 fusion |
| Gene Variant Detail | |
| Relevant Treatment Approaches | FGFR Inhibitor (Pan) FGFR2 Inhibitor |
| 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 | 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 | 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 | cholangiocarcinoma | predicted - sensitive | FGFR2 Inhibitor | 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 | 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 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 | 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 | 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 | gastroesophageal junction adenocarcinoma | predicted - sensitive | FGFR Inhibitor (Pan) | 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 | FGFR2 Inhibitor | 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 FGFR2 fusion in culture, and led to inhibition of tumor growth in a cell line xenograft model (PMID: 38801887). | 38801887 |