Molecular Profile Detail

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Profile Name FGFR1 over exp
Gene Variant Detail

FGFR1 over exp (no effect)

Relevant Treatment Approaches FGFR Inhibitor (Pan) FGFR1 Inhibitor GSK3052230

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Molecular Profile Indication/Tumor Type Response Type Relevant Treatment Approaches Therapy Name Approval Status Evidence Type Efficacy Evidence References
FGFR1 over exp Her2-receptor negative breast cancer predicted - sensitive FGFR1 Inhibitor Lucitanib Phase II Actionable In a Phase II (FINESSE) trial, Lucitanib (E-3810) treatment resulted in improved objective response rate (25%, 5/20 vs 8%, 3/39) and median progression-free survival (158 vs 109 days) in patients with metastatic hormone receptor-positive, Erbb2 (Her2)-negative breast cancer with high Fgfr1 expression (H-score>=50) compared to those with low Fgfr1 expression (H-score<50) (PMID: 31619444; NCT02053636). 31619444
FGFR1 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
FGFR1 over exp renal cell carcinoma not applicable Sorafenib Phase II Emerging In a clinical analysis of a Phase II trial, high Fgfr1 expression level was associated with decreased progression free survival in renal cell carcinoma patients treated with Nexavar (sorafenib) (PMID: 25900027). 25900027
FGFR1 over exp lung cancer predicted - sensitive FGFR Inhibitor (Pan) Rogaratinib Preclinical - Pdx Actionable In a preclinical study, a lung cancer patient-derived xenograft (PDX) model with FGFR1 overexpression demonstrated decreased tumor volume when treated with Rogaratinib (BAY 1163877) (PMID: 30807645). 30807645
FGFR1 over exp uterus leiomyosarcoma sensitive FGFR1 Inhibitor AZD4547 Preclinical - Cell culture Actionable In a preclinical study, AZD4547 inhibited survival of FGFR1 over expressing uterus leiomyosarcoma cells in culture (PMID: 27535980). 27535980
FGFR1 over exp thyroid gland cancer sensitive FGFR Inhibitor (Pan) Lenvatinib Preclinical Actionable In a preclinical study, Lenvima (lenvatinib) inhibited FGFR1 phosphorylation and signaling in thyroid cancer cells overexpressing FGFR1 (PMID: 25295214). 25295214
FGFR1 over exp uterus leiomyosarcoma sensitive FGFR Inhibitor (Pan) Infigratinib Preclinical - Cell culture Actionable In a preclinical study, Infigratinib (BGJ398) inhibited survival of FGFR1-overexpressing uterus leiomyosarcoma cells in culture (PMID: 27535980). 27535980
FGFR1 over exp lung cancer predicted - sensitive FGFR Inhibitor (Pan) Docetaxel + Rogaratinib Preclinical - Pdx Actionable In a preclinical study, the combination of Rogaratinib (BAY 1163877) and Taxotere (docetaxel) resulted in improved inhibition of tumor growth and duration of response, leading to three complete responses and seven partial responses compared to Taxotere (docetaxel) alone, resulting in only six partial responses, in lung cancer patient-derived xenograft models with FGFR1 overexpression (n=10) (PMID: 30807645). 30807645
FGFR1 over exp head and neck squamous cell carcinoma sensitive FGFR Inhibitor (Pan) Infigratinib Preclinical Actionable In a preclinical study, Infigratinib (BGJ398) inhibited cell growth and induced apoptosis in HNSCC cells over expressing Fgfr1 in culture and in xenograft models (PMID: 26015511). 26015511
FGFR1 over exp Advanced Solid Tumor sensitive FGFR Inhibitor (Pan) PRN1371 Preclinical - Cell culture Actionable In a preclinical study, PRN1371 inhibited proliferation of transformed cells over expressing wild-type FGFR1 in culture (PMID: 28978721). 28978721
FGFR1 over exp colon cancer sensitive FGFR Inhibitor (Pan) Rogaratinib Preclinical Actionable In a preclinical study, syngeneic colon cancer mouse models with FGFR1 over expression demonstrated antitumor activity when treated with Rogaratinib (BAY 1163877), with a partial response observed in 22% (2/9) and stable disease in one (PMID: 30807645). 30807645
FGFR1 over exp uterus leiomyosarcoma sensitive FGFR1 Inhibitor PD173074 Preclinical - Cell culture Actionable In a preclinical study, PD173074 inhibited survival of FGFR1 over expressing uterus leiomyosarcoma cells in culture (PMID: 27535980). 27535980
FGFR1 over exp Advanced Solid Tumor sensitive FGFR1 Inhibitor Derazantinib Preclinical - Cell culture Actionable In a preclinical study, Derazantinib (ARQ 087) inhibited growth of transformed cells overexpressing Fgfr1 in culture (PMID: 27627808). 27627808
Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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) Active, not recruiting USA 5
NCT03473756 Phase Ib/II Atezolizumab Atezolizumab + Rogaratinib Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma (FORT-2) Recruiting USA 7
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 | CAN 27
NCT04040725 Phase II Rogaratinib Rogaratinib for BCG Refractory High Risk Non-Muscle Invasive Bladder Cancer With FGFR1/2 Overexpression Withdrawn 0