Molecular Profile Detail

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Profile Name FGFR3 over exp
Gene Variant Detail

FGFR3 over exp (no effect)

Relevant Treatment Approaches FGFR Inhibitor (Pan) FGFR3 Antibody FGFR3 Inhibitor

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Molecular Profile Indication/Tumor Type Response Type Relevant Treatment Approaches Therapy Name Approval Status Evidence Type Efficacy Evidence References
FGFR3 over exp multiple myeloma sensitive FGFR3 Antibody Vofatamab Phase I Actionable In a Phase I trial, Vofatamab (B-701) demonstrated safety and resulted in stable disease in 42% (6/14) of multiple myeloma patients overexpressing FGFR3 (Blood (ASH Annual Meeting Abstracts) 2012 120: Abstract 4029). detail...
FGFR3 over exp glioblastoma sensitive U0126 Preclinical Actionable In a preclinical study, U0126 inhibited downstream signaling and growth of glioblastoma cells over-expressing Fgfr3 in culture (PMID: 23298836). 23298836
FGFR3 over exp transitional cell carcinoma sensitive FGFR3 Inhibitor Fexagratinib Preclinical Actionable In a preclinical study, AZD4547 inhibited proliferation of urothelial cancer cells with over expression of FGFR3 in culture (PMID: 22869148). 22869148
FGFR3 over exp transitional cell carcinoma sensitive FGFR3 Inhibitor AZ8010 Preclinical Actionable In a preclinical study, AZ8010 inhibited proliferation of urothelial cancer cells with over expression of FGFR3 in culture (PMID: 22869148). 22869148
FGFR3 over exp Advanced Solid Tumor sensitive FGFR Inhibitor (Pan) LY2874455 Preclinical Actionable In a preclinical study, LY2874455 induced tumor regression in FGFR3-over expressing bladder and multiple myeloma xenograft models (PMID: 21900693). 21900693
FGFR3 over exp urinary bladder cancer sensitive FGFR3 Inhibitor SU5402 Preclinical Actionable In a preclinical study, SU5402 inhibited growth of bladder cancer cells over expressing wild-type FGFR3 in culture (PMID: 21119661). 21119661
FGFR3 over exp head and neck squamous cell carcinoma sensitive FGFR Inhibitor (Pan) Rogaratinib Preclinical Actionable In a preclinical study, Rogaratinib (BAY 1163877) inhibited tumor growth in a head and neck squamous cell carcinoma xenograft model with FGFR3 overexpression (Cancer Res August 1, 2015 75:772). detail...
FGFR3 over exp urinary bladder cancer sensitive FGFR Inhibitor (Pan) Dovitinib Phase II Actionable In a Phase II trial, Dovitinib (TKI258) treatment resulted in complete response for 6 months in 8% (1/13) of non-muscle invasive bladder cancer patients over expressing FGFR3 (J Clin Oncol 34, 2016 (suppl; abstr 4526)). detail...
FGFR3 over exp urinary bladder cancer sensitive FGFR Inhibitor (Pan) Infigratinib Preclinical - Pdx Actionable In a preclinical study, treatment with Truseltiq (infigratinib) led to improved progression-free survival in a patient-derived xenograft (PDX) model of bladder cancer with FGFR3 over expression (PMID: 26270481). 26270481
FGFR3 over exp urinary bladder cancer sensitive Dactolisib + Sorafenib Preclinical - Pdx Actionable In a preclinical study, the combination of BEZ235 and Nexavar (sorafenib) resulted in improved progression-free survival in an FGFR3-over expressing patient-derived xenograft (PDX) model of bladder cancer with secondary resistance to BGJ398 due to reactivation of downstream signaling, as evidenced by increased activation of Akt and Erk (PMID: 26270481). 26270481
FGFR3 over exp Advanced Solid Tumor sensitive FGFR Inhibitor (Pan) PRN1371 Preclinical - Cell culture Actionable In a preclinical study, PRN1371 inhibited proliferation in transformed cells overexpressing wild-type FGFR3 in culture (PMID: 28978721). 28978721
FGFR3 over exp Advanced Solid Tumor predicted - sensitive FGFR Inhibitor (Pan) Rogaratinib Phase I Actionable In a Phase I trial, treatment with Rogaratinib (BAY 1163877) was well-tolerated and resulted in objective response rate (ORR) of 15% (15/100) in patients with FGFR1, FGFR2, or FGFR3-overexpressing advanced solid tumors, including urothelial cancer, head and neck squamous cell carcinoma, and non-small cell lung cancer, and led to an ORR of 67% (10/15) in patients with FGFR overexpression, but without an FGFR genetic aberration (PMID: 31405822; NCT01976741). 31405822
FGFR3 over exp lung squamous cell carcinoma no benefit FGFR Inhibitor (Pan) Rogaratinib Phase II Actionable In a Phase II trial (SAKK 19/18), Rogaratinib (BAY 1163877) treatment did not meet its primary endpoint for 6-month progression-free survival (PFS) in patients with advanced lung squamous cell carcinoma with overexpression of FGFR1, FGFR2, or FGFR3, and resulted in only 6.7% (1/15) of patients achieving 6-month PFS, with no objective responses, a median PFS of 1.6 months, and a median overall survival of 3.5 months (PMID: 36099710; NCT03762122). 36099710
FGFR3 over exp transitional cell carcinoma no benefit FGFR Inhibitor (Pan) Rogaratinib Phase II Actionable In a Phase II trial (FORT-1), Rogaratinib (BAY 1163877) treatment did not result in improved outcomes compared to chemotherapy in advanced or metastatic urothelial carcinoma patients with FGFR1 or FGFR3 overexpression, with similar median overall survival (8.3 mo vs 9.8 mo), median progression-free survival (2.7 mo vs. 3.2 mo), and objective response rate (20.7% (18/87) vs 19.3% (17/88)), failing to meet the predetermined criteria for continuation to Phase III (PMID: 36240478; NCT03410693). 36240478
FGFR3 over exp transitional cell carcinoma sensitive FGFR Inhibitor (Pan) Atezolizumab + Rogaratinib Phase I Actionable In a Phase Ib trial (FORT-2), Tecentriq (atezolizumab) and Rogaratinib (BAY 1163877) combined therapy demonstrated safety and led to an objective response rate (ORR) of 43% (16/37, 5 complete and 11 partial responses), disease control rate of 65% (24/37), median progression-free survival of 6.1 mo, median overall survival of 12.0 mo, and ORR of 54% (14/26) at the RP2D of 600mg in cisplatin-ineligible patients with metastatic urothelial cancer with FGFR1 or FGFR3 overexpression (PMID: 39298147; NCT03473756). 39298147