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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 | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| 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 |
| 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 | 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 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 | 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 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 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 | 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 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 | 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 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 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 | 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 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 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 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 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 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 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 | predicted - 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 |