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| Profile Name | FGFR2 rearrange |
| 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 rearrange | cholangiocarcinoma | sensitive | FGFR Inhibitor (Pan) | 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 | 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 rearrange | 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 rearrange | 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 rearrange | 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 rearrange | 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 rearrange | pancreatic ductal adenocarcinoma | predicted - sensitive | FGFR Inhibitor (Pan) | 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 | 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 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 | FGFR2 Inhibitor | 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 | predicted - sensitive | FGFR Inhibitor (Pan) | 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 |