Molecular Profile |
Indication/Tumor Type |
Response Type |
Therapy Name |
Approval Status |
Evidence Type |
Efficacy Evidence |
References |
FGFR3 mutant
|
Advanced Solid Tumor
|
sensitive
|
Infigratinib
|
Preclinical |
Actionable |
In a preclinical study, tumor cell lines with FGFR3 mutations demonstrated sensitivity to Truseltiq (infigratinib) in culture (PMID: 23002168).
|
23002168
|
FGFR3 mutant
|
transitional cell carcinoma
|
no benefit
|
Nivolumab
|
Phase II |
Actionable |
In a Phase II trial (CheckMate 275), Opdivo (nivolumab) (n=270) treatment resulted in similar response rate (20% vs 21%, p=0.2) in patients with FGFR3 mutant or wild-type metastatic transitional cell carcinoma (PMID: 31272788).
|
31272788
|
FGFR3 mutant
|
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 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
|
FGFR3 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...
|
FGFR3 mutant
|
bladder urothelial carcinoma
|
sensitive
|
Infigratinib
|
Phase I |
Actionable |
In a Phase I trial, patients with bladder urothelial carcinoma harboring an FGFR3 mutation demonstrated a disease control rate of 75% (6/8) when treated with Truseltiq (infigratinib), including 3 patients with a partial response and 3 with stable disease (PMID: 27870574; NCT01004224).
|
27870574
|
FGFR3 mutant
|
bladder urothelial carcinoma
|
sensitive
|
Erdafitinib
|
FDA approved - Has Companion Diagnostic |
Actionable |
In a Phase II trial (BCL2001) that supported FDA approval, 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 (PMID: 31340094; NCT02365597).
|
detail...
31340094
detail...
|
FGFR3 mutant
|
bladder urothelial carcinoma
|
sensitive
|
Erdafitinib
|
Guideline |
Actionable |
Balversa (erdafitinib) is included in the guidelines for patients with advanced or metastatic urothelial carcinoma harboring Fgfr3 alterations after progression on platinum-based regimens (NCCN.org).
|
detail...
|
FGFR3 mutant
|
urinary bladder cancer
|
sensitive
|
AZD4547
|
Preclinical - Cell culture |
Actionable |
In a preclinical study, AZD4547 inhibited survival of bladder cancer cells harboring FGFR3 mutation in culture (PMID: 27550940).
|
27550940
|
FGFR3 mutant
|
transitional cell carcinoma
|
sensitive
|
Infigratinib
|
Clinical Study |
Actionable |
In a clinical study, Truseltiq (infigratinib) treatment in patients with FGFR3 alterations led to 25.4% (17/67) confirmed responses and a disease control rate of 64% (43/67), which included complete responses, partial responses, and stable disease, and resulted in a median progression-free survival of 3.75 months and a median overall survival of 7.75 months (PMID: 29848605).
|
29848605
|
FGFR3 mutant
|
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); NCT01004224).
|
detail...
|
FGFR3 mutant
|
transitional cell carcinoma
|
sensitive
|
Erdafitinib
|
Case Reports/Case Series |
Actionable |
In a Phase I trial, Balversa (erdafitinib) treatment resulted in 25% tumor shrinkage at week 8 in an urothelial cancer patient harboring FGFR3 mutations (PMID: 26324363; NCT01703481).
|
26324363
|
FGFR3 mutant
|
transitional cell carcinoma
|
sensitive
|
Erdafitinib
|
Guideline |
Actionable |
Balversa (erdafitinib) is included in the guidelines for patients with advanced or metastatic urothelial carcinoma harboring Fgfr3 alterations after progression on platinum-based regimens (NCCN.org).
|
detail...
|
FGFR3 mutant
|
transitional cell carcinoma
|
sensitive
|
Erdafitinib
|
FDA approved - Has Companion Diagnostic |
Actionable |
In a Phase II trial (BCL2001) that supported FDA approval, 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 (PMID: 31340094; NCT02365597).
|
detail...
31340094
detail...
|
FGFR3 mutant
|
transitional cell carcinoma
|
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 mutant
|
transitional cell carcinoma
|
no benefit
|
Atezolizumab
|
Phase II |
Actionable |
In a Phase II trial (IMVigor 210, CheckMate 275), Tecentriq (atezolizumab) (n=119) treatment resulted in similar response rate (24% vs 21%, p=0.8) in patients with FGFR3 mutant or wild-type metastatic transitional cell carcinoma (PMID: 31272788).
|
31272788
|
FGFR3 mutant
|
Advanced Solid Tumor
|
sensitive
|
Pemigatinib
|
Preclinical - Cell line xenograft |
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...
|
FGFR3 mutant
|
bladder urothelial carcinoma
|
sensitive
|
Dovitinib
|
Phase II |
Actionable |
In a Phase II trial, Dovitinib (TKI258) treatment resulted in complete response in 33% (1/3) of patients with BCG-unresponsive, non-muscle-invasive, urothelial carcinoma of the bladder harboring FGFR3 mutations (PMID: 27932416).
|
27932416
|
FGFR3 mutant
|
Advanced Solid Tumor
|
predicted - sensitive
|
Debio 1347
|
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
|