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| Profile Name | FGFR3 fusion |
| Gene Variant Detail | |
| Relevant Treatment Approaches |
| Molecular Profile | Indication/Tumor Type | Response Type | Relevant Treatment Approaches | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|---|
| FGFR3 fusion | Advanced Solid Tumor | predicted - sensitive | Futibatinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Lytgobi (futibatinib) demonstrated growth inhibition and reduced FGFR phosphorylation in human cancer cell lines and xenograft models harboring FGFR mutations (Mol Cancer Ther 2013;12(11 Suppl):A270). | detail... | |
| FGFR3 fusion | transitional cell carcinoma | sensitive | Infigratinib | Phase I | Actionable | In a Phase I trial, Truseltiq (infigratinib) treatment resulted in complete response in 4% (1/25) and partial response in 32% (8/25) of urothelial carcinoma patients harboring FGFR3 mutations or fusions (J Clin Oncol 34, 2016 (suppl; abstr 4517)). | detail... | |
| FGFR3 fusion | urinary bladder cancer | sensitive | Fexagratinib | Preclinical - Cell culture | Actionable | In a preclinical study, AZD4547 inhibited survival of bladder cancer cells harboring FGFR3 fusion in culture (PMID: 27550940). | 27550940 | |
| FGFR3 fusion | transitional cell carcinoma | predicted - sensitive | Docetaxel + Vofatamab | Phase Ib/II | Actionable | In a Phase I/II trial, Vofatamab (B-701) in combination with Taxotere (docetaxel) demonstrated safety and preliminary efficacy, resulted in enhanced activity in patients with locally advanced or metastatic urothelial carcinoma harboring FGFR3 mutations or fusions comparing to wild-type patients (Journal of Clinical Oncology 36, no. 15_suppl (May 20 2018) 4534-4534; NCT02401542). | detail... | |
| FGFR3 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 | |
| FGFR3 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 | |
| FGFR3 fusion | urinary bladder cancer | sensitive | Regorafenib | Preclinical - Cell culture | Actionable | In a preclinical study, bladder cancer cell lines harboring an FGFR3 fusion were sensitive to treatment with Stivarga (regorafenib), demonstrating inhibition of cell growth (PMID: 33563752). | 33563752 | |
| FGFR3 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 | |
| FGFR3 fusion | transitional cell carcinoma | sensitive | Pemigatinib | Phase II | Actionable | In a Phase II trial (FIGHT-201), Pemazyre (pemigatinib) treatment resulted in an objective response rate (ORR) of 17.8%, median duration of response (mDOR) of 6.2 mo, median progression-free survival (mPFS) of 4.0 mo, and median overall survival (mOS) of 6.8 mo with continuous dosing, and an ORR of 23.3%, mDOR of 6.2 mo, mPFS of 4.3 mo, and mOS of 8.9 mo with intermittent dosing in patients with urothelial carcinoma harboring FGFR3 mutations or fusions/rearrangements (PMID: 37956738; NCT02872714). | 37956738 | |
| FGFR3 fusion | transitional 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 urothelial carcinoma harboring an FGFR3 fusion (ESMO Open 9 (2024): 102274); NCT05244551). | detail... | |
| FGFR3 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 | |
| FGFR3 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 | |
| FGFR3 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 | |
| FGFR3 fusion | transitional cell carcinoma | no benefit | Derazantinib | Phase Ib/II | Actionable | In a Phase I/II trial (FIDES-02), Derazantinib (ARQ 087) treatment was well tolerated but demonstrated limited efficacy in patients with urothelial carcinoma harboring FGFR1 (n=4), FGFR2 (n=7), or FGFR3 (n=35) mutations or FGFR3 fusions (n=6), with an objective response rate of 8.2% (4/49, all partial responses) and disease control rate of 30.6% (15/49) by independent central review (PMID: 38627238; NCT04045613). | 38627238 | |
| FGFR3 fusion | transitional cell carcinoma | no benefit | Atezolizumab + Derazantinib | Phase Ib/II | Actionable | In a Phase I/II trial (FIDES-02), combination treatment with Derazantinib (ARQ 087) and Tecentriq (atezolizumab) was well tolerated but demonstrated limited efficacy in patients with urothelial carcinoma harboring FGFR3 mutations (n=8) or FGFR3 fusions (n=2), with an objective response rate (ORR) of 0% (0/10) and disease control rate of 20.0% (2/10) by independent central review (PMID: 38627238; NCT04045613). | 38627238 | |
| FGFR3 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... | |
| FGFR3 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... |