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 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 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 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 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 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). 31405822
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 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 lung squamous cell carcinoma no benefit FGFR Inhibitor (Pan) Rogaratinib Phase II Actionable In a Phase II trial, Rogaratinib (BAY 1163877) treatment did not result in improved progression-free survival (PFS) of metastatic lung squamous cell carcinoma patients with overexpression of FGFR1, FGFR2, or FGFR3, as only 10% (1/10) of patients achieved 6-month PFS, further clinical development of this agent was halted (J Clin Oncol 39, no. 15_suppl (May 20, 2021) e2119; NCT03762122). detail...
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 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 transitional cell carcinoma sensitive FGFR3 Inhibitor AZD4547 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 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
Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03088059 Phase II Niraparib Durvalumab + Monalizumab Methotrexate Carboplatin Rogaratinib Mitomycin C Docetaxel Afatinib Paclitaxel Durvalumab Monalizumab Palbociclib Bleomycin Gemcitabine Fluorouracil Biomarker-based Study in R/M SCCHN (UPSTREAM) Recruiting ITA | FRA | BEL 1
NCT03410693 Phase II Docetaxel Vinflunine Paclitaxel Rogaratinib Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma (FORT-1) Completed USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT 21
NCT03473756 Phase Ib/II Atezolizumab Atezolizumab + Rogaratinib Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma (FORT-2) Active, not recruiting USA | ITA | FRA | ESP | DEU | AUT 2
NCT04040725 Phase II Rogaratinib Rogaratinib for BCG Refractory High Risk Non-Muscle Invasive Bladder Cancer With FGFR1/2 Overexpression Withdrawn 0
NCT03517956 Phase I Copanlisib + Rogaratinib Phase 1 Study of the Combination of Rogaratinib With Copanlisib in Patients With Fibroblast Growth Factor Receptor (FGFR)-Positive, Locally Advanced or Metastatic Solid Tumors (ROCOCO) Completed USA | ESP | DEU | BEL 2