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BIOMARKER:

FGFR mutation

i
Other names: FGFR, Fibroblast Growth Factor Receptor
Related biomarkers:
10d
Intrahepatic cholangiocarcinoma: tumour heterogeneity and its clinical relevance. (PubMed, Clin Mol Hepatol)
However, caution is advised with the pathological diagnosis as iCCA shows tumour heterogeneity, making it difficult to distinguish small duct type iCCA from hepatocellular carcinoma (HCC), and combined HCC-CCA. This review focuses on the pathological/molecular features of both subtypes of iCCA (large and small duct type), as well as diagnostic pitfalls, their clinical relevance, and future perspectives.
Clinical • Review • Journal
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FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation • FGFR fusion
2ms
Case Report: Erdafitinib-induced Central Serous Chorioretinopathy. (PubMed, Optom Vis Sci)
Erdafitinib, a potent tyrosine kinase receptor inhibitor of fibroblast growth factor receptors 1-4, demonstrates anti-tumor activity in advanced urothelial carcinoma with fibroblast growth factor receptor mutations with a response rate of approximately 40%. However, central serous chorioretinopathy develops in 25% of patients treated with daily 8 milligram dose of erdafitinib. While most mild to moderate erdafitinib induced central serous chorioretinopathies resolve with dose interruption or reduction, occasionally discontinuation of the medication is necessary. Therefore, careful coordination with oncologists is important to assess the impact of erdafitinib on vision, quality of life, and survival prognosis.
Clinical • Journal
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FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation
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Balversa (erdafitinib)
2ms
Determination of total and unbound levels of a potent inhibitor of fibroblast growth factor receptor, infigratinib, in human plasma, cerebrospinal fluid and brain tumor by a validated LC-MS/MS assay (SNO 2021)
CONCLUSIONS A sensitive and rapid bioanalytical method is successfully developed and validated to quantify total and unbound infigratinib levels in human plasma, CSF and glioblastoma tissue. The method is presently employed to evaluate plasma pharmacokinetics and CNS penetration of infigratinib in recurrent glioblastoma patients in an ongoing Phase 0 clinical trial.
FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation
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Truseltiq (infigratinib)
3ms
Clinical • Trial completion date
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FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation • FGFR fusion
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gemcitabine • Balversa (erdafitinib) • mitomycin
3ms
CR108661: A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations (clinicaltrials.gov)
P2, N=336, Recruiting, Janssen Research & Development, LLC | Trial completion date: Sep 2026 --> Nov 2027
Clinical • Trial completion date
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FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation • FGFR fusion
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Balversa (erdafitinib)
3ms
Study to Evaluate the Efficacy and Safety of TT-00420 in Cholangiocarcinoma (clinicaltrials.gov)
P2, N=80, Not yet recruiting, TransThera Sciences (Nanjing), Inc. | Trial completion date: Jun 2023 --> Sep 2023
Clinical • Trial completion date
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FGFR2 (Fibroblast growth factor receptor 2)
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FGFR2 mutation • FGFR2 fusion • FGFR1 mutation • FGFR mutation • FGFR1 fusion • FGFR wild-type
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TT-00420
3ms
The frequency and somatic mutation landscape of Fibroblast growth factor receptor ( FGFR ) alterations in breast cancer (SABCS 2021)
High-level FGFR amplifications are observed in >11% of breast cancers, especially the ER+/HER2- subtype, while mutations/fusions are rare. These data support the ongoing studies evaluating targeted therapies for FGFR amplified ER + breast cancer. Correlations with clinical information (MC cohort) and associations with actionable alterations are ongoing and may inform potential combination strategies.
Tumor Mutational Burden • BRCA Biomarker • MSi-H Biomarker
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • PTEN (Phosphatase and tensin homolog) • FGFR2 (Fibroblast growth factor receptor 2) • FGFR3 (Fibroblast growth factor receptor 3) • FGFR1 (Fibroblast growth factor receptor 1) • CCND1 (Cyclin D1) • TACC3 (Transforming acidic coiled-coil containing protein 3) • FGFR (Fibroblast Growth Factor Receptor) • CDK4 (Cyclin-dependent kinase 4) • FGFR4 (Fibroblast growth factor receptor 4) • PIK3R1 (Phosphoinositide-3-Kinase Regulatory Subunit 1) • BAG4 (BAG Cochaperone 4) • EMSY (EMSY Transcriptional Repressor BRCA2 Interacting) • TACC1 (Transforming Acidic Coiled-Coil Containing Protein 1)
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MSI-H/dMMR • HER-2 amplification • HER-2 negative • HER-2 mutation • FGFR1 amplification • FGFR2 mutation • FGFR2 fusion • FGFR2 N549K • FGFR mutation • FGFR1 fusion • FGFR3 fusion • FGFR fusion • FGFR3 Y375C • FGFR2 Y375C
5ms
Clinical • Trial completion date
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FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation • FGFR fusion
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gemcitabine • Balversa (erdafitinib) • mitomycin
5ms
PEGASUS: Safety and Efficacy of Pemigatinib in Patients With High-risk Urothelial Cancer After Radical Surgery (clinicaltrials.gov)
P2; Trial completion date: Jan 2024 --> Oct 2024 | Trial primary completion date: Jul 2023 --> Apr 2024
Trial completion date • Trial primary completion date • Clinical
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FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation
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FoundationOne® CDx
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Pemazyre (pemigatinib)
6ms
[VIRTUAL] Stacking on the Targets: Secondary Resistant, Potential Targetable Genetic Alterations in Patients With Epidermal Growth Factor Receptor NSCLC (IASLC-WCLC 2021)
One patient had BRAF V600E mutation and received BRAF+MEK inhibitors in addition to continuing osimertinib with excellent clinical response, and 1 had HER2 mutation who received carboplatin/pemetrexed/pembrolizumab. Ongoing trials such as the ORCHARD trial are looking at biomarker-driven therapies for patients who progress on osimertinib but do not account for rarer or newer actionable mutations. Real world data on specifics of resistance mutations to osimertinib could lay the foundation for more robust multi-arm clinical trials.
Clinical • PD(L)-1 Biomarker
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EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • FGFR1 (Fibroblast growth factor receptor 1)
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BRAF V600E • EGFR mutation • BRAF V600 • EGFR L858R • EGFR T790M • MET amplification • EGFR exon 19 deletion • ALK fusion • RET mutation • ROS1 fusion • MET mutation • FGFR1 mutation • FGFR mutation • FGFR1 fusion • BRAF amplification
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Keytruda (pembrolizumab) • Tagrisso (osimertinib) • carboplatin • pemetrexed
6ms
[VIRTUAL] The Characteristics of FGFR Genetic Aberrations in Chinese Lung Cancer Patients (IASLC-WCLC 2021)
Frequency of FGFR fusions Fusions Fusion region N (%) FGFR3-TACC3 EX18E:EX11 3(7.14%) EX17:EX8 3(7.14%) EX17:EX10 2(4.76%) EX18E:EX13 1(2.38%) EX8:EX9 1(2.38%) FGFR3-LETM1 EX8:Promoter 1(2.38%) FGFR3-SZT2 EX7:EX61 1(2.38%) FGFR3-PCDH7(intergenic) EX8:intergenic 1(2.38%) FAM53A(intergenic)-FGFR3 intergenic:EX18E,intergenic:EX8 2(4.76%) FGFR3-chr20 55284041 EX18E:chr20 55284041 1(2.38%) FGFR2-FAM184B EX17:EX8 1(2.38%) FGFR2-GRK5 EX17:EX1 1(2.38%) FGFR2-SORBS1 EX17:EX24 1(2.38%) FGFR2-PROM1 EX18:EX11 1(2.38%) FGFR2-chr10 122732846 EX17:chr10 122732846 1(2.38%) FGFR2-NPVF(intergenic) EX14:intergenic 1(2.38%) OPALIN-FGFR2 EX6E:EX2 1(2.38%) ATE1-FGFR2 EX11:EX2,EX5:EX17 2(4.76%) chr10 123156582-FGFR2 chr10 123156582:EX18 1(2.38%) DEC1(intergenic)-FGFR2 intergenic:EX6 1(2.38%) FGFR1-TACC1 EX1:EX2 1(2.38%) FGFR1-STAU1 EX1:EX7 1(2.38%) FGFR1-LETM2 EX12:EX8 1(2.38%) FGFR1-KCNU1(intergenic) EX3:intergenic 1(2.38%) FGFR1-SLC22A23 EX13:EX10 1(2.38%) FGFR1-ISL1(intergenic) EX8:intergenic,EX4:intergenic 2(4.76%) DDHD2-FGFR1 EX5:EX2 1(2.38%) ZMAT4-FGFR1 EX2:EX2 1(2.38%) HELZ-FGFR1 EX33E:EX6 1(2.38%) chr8 76149982-FGFR1 EX0:EX2 1(2.38%) chr8 138590655-FGFR1 EX0:EX2 1(2.38%) UNC5D(intergenic)-FGFR1 intergenic:EX2 1(2.38%) LOC100996508-FGFR1 EX1:EX2 1(2.38%) TACC1(intergenic)-FGFR1 intergenic:EX2 1(2.38%) Total 42(100%) Conclusion We report the prevalence of FGFR aberrations in a large lung cancer pts, including mutations, gene amplifications, gene deletion and one novel FGFR fusion. Our results revealed the potential therapeutic strategies with FGFR inhibitors for Chinese patients with lung cancer.
Clinical
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ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • FGFR2 (Fibroblast growth factor receptor 2) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • FGFR3 (Fibroblast growth factor receptor 3) • FGFR1 (Fibroblast growth factor receptor 1) • TACC3 (Transforming acidic coiled-coil containing protein 3) • FGFR (Fibroblast Growth Factor Receptor) • FGFR4 (Fibroblast growth factor receptor 4) • SORBS1 (Sorbin And SH3 Domain Containing 1)
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MET amplification • FGFR1 amplification • EGFR overexpression • FGFR2 mutation • ALK fusion • FGFR2 fusion • RET mutation • ALK mutation • ROS1 fusion • MET mutation • FGFR mutation • FGFR2 overexpression • FGFR1 fusion • FGFR fusion • FGFR3 amplification • ALK-ROS1 fusion • FGFR2 expression
6ms
[VIRTUAL] Genomic Profiles and Potential Determinants of Response and Resistance in KRAS p.G12C - mutated NSCLC Treated With Sotorasib (IASLC-WCLC 2021)
The presence of KEAP1 mutation was observed across all groups and was more prevalent in early progressors. These findings warrant further investigation of the longitudinal cfDNA dynamics in patients receiving sotorasib.
IO biomarker
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EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • FGFR (Fibroblast Growth Factor Receptor)
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KRAS mutation • EGFR mutation • KRAS G12C • KEAP1 mutation • RET mutation • MET mutation • KRAS G12 • FGFR mutation • MTOR mutation
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Lumakras (sotorasib)
6ms
[VIRTUAL] The analysis of FGFR-gene family alterations in glioma (ESMO 2021)
We report the prevalence of FGFR variants was 9.1% in in Chinese glioma patients, including mutations, gene amplifications, and novel FGFR fusions. Moreover, targeting FGFR pathway in gliomas with FGFR alterations may be a therapeutic strategy.
FGFR2 (Fibroblast growth factor receptor 2) • FGFR3 (Fibroblast growth factor receptor 3) • FGFR1 (Fibroblast growth factor receptor 1) • FGFR (Fibroblast Growth Factor Receptor) • FGFR4 (Fibroblast growth factor receptor 4) • CEACAM1 (CEA Cell Adhesion Molecule 1)
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FGFR2 mutation • FGFR2 fusion • FGFR mutation • FGFR1 fusion • FGFR fusion • FGFR3 amplification • FGFR4 mutation
6ms
[VIRTUAL] Real-world and in silico incidence of fibroblast growth factor receptor (FGFR) 1-4 molecular alterations across multiple cancer types (ESMO 2021)
Background: Deregulation of FGFR pathway has been proved to increase cells survival and proliferation leading to FDA approval of drugs in urothelial cancer (erdafitinib) and cholangiocarcinoma [CC] (pemigatinib) as well as agnostic indication trials (ongoing). Most patients do not show a FGFR alteration. Cancers of higher incidence of P are urothelial, ovarian and glioblastoma. Incidence in most of other tumor types is ≤1%.
Clinical • Real-world evidence
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FGFR1 (Fibroblast growth factor receptor 1) • FGFR (Fibroblast Growth Factor Receptor)
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FGFR1 mutation • FGFR mutation • FGFR1 fusion
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Balversa (erdafitinib) • Pemazyre (pemigatinib)
7ms
NCCH2006/MK010 Trial (FORTUNE Trial) (clinicaltrials.gov)
P2, N=45, Recruiting, National Cancer Center, Japan
Clinical • New P2 trial
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EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • FGFR2 (Fibroblast growth factor receptor 2) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • FGFR4 (Fibroblast growth factor receptor 4) • NTRK (Neurotrophic receptor tyrosine kinase)
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EGFR mutation • BRAF mutation • NRAS mutation • BRAF V600 • FGFR1 amplification • FGFR2 fusion • FGFR mutation • FGFR1 fusion
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E7090
7ms
Clinical • New P2 trial
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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ER positive • HER-2 negative • FGFR1 amplification • FGFR mutation
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Focus V (anlotinib) • fulvestrant
8ms
Using deep learning to identify bladder cancers with FGFR-activating mutations from histology images. (PubMed, Cancer Med)
TIL percentage is a computationally derived image biomarker from routine tumor histology that can predict whether a tumor has FGFR mutations. CNNs and other digital pathology methods may complement genome sequencing and provide earlier screening options for candidates of targeted therapies.
Journal
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FGFR2 (Fibroblast growth factor receptor 2) • FGFR3 (Fibroblast growth factor receptor 3) • FGFR (Fibroblast Growth Factor Receptor)
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FGFR2 mutation • FGFR3 mutation • FGFR mutation
8ms
Clinical • New P2 trial
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FGFR2 (Fibroblast growth factor receptor 2)
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FGFR2 mutation • FGFR2 fusion • FGFR1 mutation • FGFR mutation • FGFR1 fusion
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TT-00420
8ms
Targeting the Fibroblast Growth Factor Receptor (FGFR) Family in Lung Cancer. (PubMed, Cells)
We also discuss the current understanding of the mechanisms of resistance to FGFR-targeting compounds and therapeutic strategies to circumvent resistance. Finally, we highlight our perspectives on the development of new biomarkers for stratification and prediction of FGFR inhibitor response to enable personalisation of treatment in patients with lung cancer.
Review • Journal
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EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • FGFR (Fibroblast Growth Factor Receptor)
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KRAS mutation • EGFR mutation • FGFR mutation
8ms
Clinical • Trial primary completion date
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FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation
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Balversa (erdafitinib)
9ms
FOENIX-CCA2: A Study of TAS-120 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=386, Active, not recruiting, Taiho Oncology, Inc. | Trial completion date: May 2021 --> Dec 2021 | Trial primary completion date: Dec 2019 --> May 2021
Clinical • Trial completion date • Trial primary completion date
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FGFR2 (Fibroblast growth factor receptor 2) • FGF19 (Fibroblast growth factor 19)
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FGFR2 mutation • FGFR2 amplification • FGFR2 fusion • FGFR3 mutation • FGFR mutation • FGFR3 fusion • FGFR fusion • FGF19 amplification
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futibatinib (TAS 120)
9ms
CR108661: A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations (clinicaltrials.gov)
P2, N=280, Recruiting, Janssen Research & Development, LLC | Trial completion date: Sep 2025 --> Sep 2026
Clinical • Trial completion date
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FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation • FGFR fusion
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Balversa (erdafitinib)
9ms
Polymorphous low-grade neuroepithelial tumor of the young: A detailed patho-molecular analysis and discussion of a case. (PubMed, Clin Neuropathol)
PLNTYs are rare brain tumors, and their accurate diagnosis is important to avoid improper management. Their prognosis shall be stratified according to their mutations.
Clinical • Journal
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EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • TP53 (Tumor protein P53) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • FGFR (Fibroblast Growth Factor Receptor) • ATRX (ATRX Chromatin Remodeler) • CD34 (CD34 molecule)
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BRAF V600E • EGFR mutation • BRAF V600 • IDH2 mutation • FGFR mutation • TP53 expression
10ms
IDH-mutant gliomas with additional class-defining molecular events. (PubMed, Mod Pathol)
While these tumors are rare and the significance of these alterations needs further exploration, alterations in FGFR, NTRK, and BRAF could have potential therapeutic implications and affect clinical trial design and results in IDH-mutant studies. Our data highlights that single gene testing for IDH1 in diffuse gliomas may be insufficient for detection of targets with potential important prognostic and treatment value.
Journal
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BRAF (B-raf proto-oncogene) • PTEN (Phosphatase and tensin homolog) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • FGFR1 (Fibroblast growth factor receptor 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • NTRK (Neurotrophic receptor tyrosine kinase)
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BRAF V600E • BRAF V600 • FGFR1 mutation • FGFR mutation • NTRK fusion
10ms
Fibroblast growth factor receptor (FGFR) gene: pathogenesis and treatment implications in urothelial carcinoma of the bladder. (PubMed, J Clin Pathol)
In April 2020, the Food and Drug Administration (FDA) approved the first targeted FGFR therapy, erdafitinib, in patients with locally advanced or metastatic bladder cancer who have progressed on platinum-based chemotherapy. Herein, we reviewed the normal structure and function of FGFR We also explored its role in the development of urothelial carcinoma and major developments in the FGFR-targeted therapy.
Journal
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FGFR3 (Fibroblast growth factor receptor 3) • HRAS (Harvey rat sarcoma viral oncogene homolog) • FGFR (Fibroblast Growth Factor Receptor)
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HRAS mutation • FGFR3 mutation • FGFR mutation • FGFR3 fusion • FGFR3 amplification
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Balversa (erdafitinib)
11ms
Targeting FGFR in non-small cell lung cancer: implications from the landscape of clinically actionable aberrations of FGFR kinases. (PubMed, Cancer Biol Med)
We report the prevalence of FGFR anomalies in a large NSCLC population, including mutations, gene amplifications, and novel FGFR fusions.
Clinical • Journal
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FGFR2 (Fibroblast growth factor receptor 2) • FGFR3 (Fibroblast growth factor receptor 3) • FGFR1 (Fibroblast growth factor receptor 1) • TACC3 (Transforming acidic coiled-coil containing protein 3) • FGFR (Fibroblast Growth Factor Receptor) • FGFR4 (Fibroblast growth factor receptor 4)
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FGFR1 amplification • EGFR overexpression • FGFR1 overexpression • FGFR2 fusion • FGFR mutation • FGFR1 fusion • FGFR fusion
11ms
[VIRTUAL] Erdafitinib in combination with BCLXL/BCL2 inhibitor induce apoptosis in urothelial carcinoma cells without FGFR mutation (AACR 2021)
Although Erdafitinib has recently emerged as a treatment for metastatic urothelial carcinoma, it has been shown to be effective against FGFR mutations, but the target patient population is small, and a new treatment for urothelial carcinoma without FGFR mutations is needed. Furthermore, we found that in combination with Navitoclax, a BCLXL/BCL2 inhibitor, it induced potent apoptosis in urothelial carcinoma cell lines without FGFR mutation. This combination therapy may represent a new treatment for urothelial carcinoma without FGFR mutations.
Combination therapy • IO biomarker
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MCL1 (Myeloid cell leukemia 1) • FGFR (Fibroblast Growth Factor Receptor) • BCL2L1 (BCL2-like 1)
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FGFR mutation
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Balversa (erdafitinib) • navitoclax (ABT 263)
11ms
Clinical • Trial primary completion date
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FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation
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Balversa (erdafitinib)
11ms
[VIRTUAL] Clinical characteristics and treatment outcomes in lung cancer patients with FGFR genes alterations (ELCC 2021)
Conclusions Our cohort did not show that FGFR genes alterations confer distinct clinical characteristics in LG patients. However, much more investigation is needed.
Clinical • PD(L)-1 Biomarker • IO biomarker
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EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • FGFR2 (Fibroblast growth factor receptor 2) • FGFR3 (Fibroblast growth factor receptor 3) • FGFR1 (Fibroblast growth factor receptor 1) • FGFR (Fibroblast Growth Factor Receptor)
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KRAS mutation • EGFR mutation • PIK3CA mutation • FGFR2 mutation • FGFR mutation • PIK3CA mutation + KRAS mutation
12ms
PEGASUS: Safety and Efficacy of Pemigatinib in Patients With High-risk Urothelial Cancer After Radical Surgery (clinicaltrials.gov)
P2; Not yet recruiting --> Recruiting | Trial completion date: Mar 2023 --> Jan 2024 | Initiation date: Mar 2020 --> Jul 2020 | Trial primary completion date: Dec 2022 --> Jul 2023
Trial completion date • Trial primary completion date • Enrollment open • Trial initiation date • Clinical
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FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation
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FoundationOne® CDx
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cisplatin • Pemazyre (pemigatinib)
12ms
Clinical • Enrollment open • Combination therapy
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POLE (DNA Polymerase Epsilon)
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MSI-H/dMMR • FGFR1 mutation • FGFR mutation
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Pemazyre (pemigatinib) • epacadostat (INCB024360) • retifanlimab (INCMGA0012)
1year
PIK3CA gene mutations in the helical domain correlate with high tumor mutation burden and poor prognosis in metastatic breast carcinomas with late-line therapies. (PubMed, Aging (Albany NY))
Cox regression analyses suggested that PIK3CA-HD mutations, FGFR aberrations and high TMB were all significant risk factors for poor PFS. In conclusion, future research needs to focus more on the treatment strategies targeting PIK3CA-HD mutations.
Journal • Tumor Mutational Burden
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PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • NF1 (Neurofibromin 1) • FGFR (Fibroblast Growth Factor Receptor)
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TMB-H • PIK3CA mutation • FGFR mutation
1year
[VIRTUAL] A Phase 2 Study of Erdafitinib in Patients with Advanced Solid Tumors and Fibroblast Growth Factor Receptor Gene Alterations (IASLC-WCLC 2020)
Results Starting December 2019, patients will be enrolled at ~158 sites in 15 countries. Conclusion Results of this study may provide efficacy and safety data for erdafitinib across multiple FGFR-altered solid tumors and evaluate the potential benefit of targeting the underlying altered biology of FGFR irrespective of tumor histology in adult and adolescent patients.
Clinical • P2 data
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FGFR3 (Fibroblast growth factor receptor 3) • FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation • FGFR fusion
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Balversa (erdafitinib)
1year
[VIRTUAL] A Kinome CRISPR Screen in FGFR-Amplified Lung Cancer (IASLC-WCLC 2020)
Results We identify several kinases including polo-like kinase I (PLK1) as key determinants of sensitivity to AZD4547, a selective FGFR inhibitor currently investigated in phase III clinical trials. We provided evidence showing that genetic and pharmacological inhibition of PLK1 synergistically enhances the effect of FGFR inhibitors in FGFR-amplified lung SQLC. Conclusion CRISPR/Cas9 screening is a powerful tool to uncover genetic determinants underlying drug sensitivity in cancer.
FGFR (Fibroblast Growth Factor Receptor) • PLK1 (Polo Like Kinase 1)
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FGFR mutation
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ABSK091
1year
[VIRTUAL] Identification of FGFR Mutations in Chinese Lung Cancer Patients by Next-Generation Sequencing (IASLC-WCLC 2020)
Food and Drug Administration (FDA) has approved Balversa (erdafitinib) for metastatic bladder cancer treatment, and more FGFR inhibitors are currently being evaluated clinically in many other cancer types, including lung cancer...Hopefully, more patients with other FGFR mutations may benefit from FGFR inhibitors as well, which needs further clinical investigation. Meanwhile, the exclusive relationship between druggable FGFR mutations and other actionable variations in lung cancers defines a unique molecular subtype, extending the number of patients who can benefit from targeted therapy.
Clinical • Next-generation sequencing
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EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • FGFR2 (Fibroblast growth factor receptor 2) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • FGFR3 (Fibroblast growth factor receptor 3) • FGFR1 (Fibroblast growth factor receptor 1) • FGFR (Fibroblast Growth Factor Receptor) • FGFR4 (Fibroblast growth factor receptor 4)
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BRAF V600E • EGFR mutation • BRAF V600 • FGFR1 amplification • FGFR2 mutation • ALK fusion • FGFR2 fusion • ROS1 fusion • FGFR3 S249C • FGFR1 mutation • FGFR3 Y373C • FGFR mutation • FGFR3 fusion • FGFR3 G370C • FGFR3 R248C • FGFR3 Y375C • NTRK1 mutation • FGFR2 S252W
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Balversa (erdafitinib)
1year
New P2 trial • Combination therapy
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MSI (Microsatellite instability) • FGFR2 (Fibroblast growth factor receptor 2) • POLE (DNA Polymerase Epsilon)
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MSI-H/dMMR • FGFR2 mutation • FGFR2 fusion • FGFR mutation • FGFR1 fusion • FGFR2 rearrangement
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Pemazyre (pemigatinib) • epacadostat (INCB024360) • retifanlimab (INCMGA0012)
1year
[VIRTUAL] A phase II open-label study in adult and adolescent patients (pts) with advanced solid tumors harboring fibroblast growth factor receptor (FGFR) gene alterations. (ASCO-GI 2021)
As of December 2019, pts are being enrolled at ~158 sites in 15 countries. Results of this study will provide efficacy and safety data for erdafitinib across multiple solid tumors with FGFR alterations and evaluate the potential benefit of targeting the underlying altered biology of FGFR irrespective of tumor histology in adult and adolescent pts.
Clinical • P2 data
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FGFR3 (Fibroblast growth factor receptor 3) • FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation • FGFR fusion
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Balversa (erdafitinib)
1year
Clinical • Trial completion date
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FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation
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Balversa (erdafitinib)
1year
A comprehensive pan-cancer study of fibroblast growth factor receptor aberrations in Chinese cancer patients. (PubMed, Ann Transl Med)
FGFR1 amplification was the most common genetic alteration in CRC, breast cancer, and lung cancer; while FGFR2 amplification was more commonly observed in gastric cancer than in other cancers in our cohort. Our study advances the understanding of the distribution of FGFR aberrations in various cancer types in the Chinese population, which will facilitate the further development of FGFR inhibitors.
Clinical • Journal • Pan Tumor
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FGFR2 (Fibroblast growth factor receptor 2) • FGFR3 (Fibroblast growth factor receptor 3) • FGFR1 (Fibroblast growth factor receptor 1) • FGFR (Fibroblast Growth Factor Receptor) • FGFR4 (Fibroblast growth factor receptor 4)
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FGFR1 amplification • FGFR2 amplification • FGFR mutation • FGFR fusion
1year
[VIRTUAL] FGFR Gene Mutation Analysis in Urothelial Cancer Using the therascreen FGFR RGQ Assay in FFPE Specimen Type (AMP 2020)
The test is indicated for use as an aid in identifying patients with urothelial cancer (UC) which harbor these alterations and are therefore eligible for treatment with BALVERSA (erdafitinib)... The therascreen FGFR RGQ RT-PCR Test is a robust, reproducible and fast assay for molecular diagnostic utilization in urothelial cancer using FFPE specimen type.
FGFR3 (Fibroblast growth factor receptor 3) • FGFR (Fibroblast Growth Factor Receptor)
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FGFR3 mutation • FGFR3 S249C • FGFR3 Y373C • FGFR mutation • FGFR3 fusion • FGFR3 R248C • IKZF1 deletion + PAX5 deletion
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Balversa (erdafitinib)
1year
Erdafitinib: A novel therapy for FGFR-mutated urothelial cancer. (PubMed, Am J Health Syst Pharm)
Erdafitinib is the first small-molecule FGFR inhibitor approved for use in advanced bladder cancer.
Journal
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FGFR2 (Fibroblast growth factor receptor 2) • FGFR3 (Fibroblast growth factor receptor 3) • FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation
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Balversa (erdafitinib)
1year
Safety and Efficacy of Ponatinib for Treatment of Pediatric Recurrent or Refractory Leukemias or Solid Tumors (clinicaltrials.gov)
P1/2, N=60, Recruiting, Incyte Biosciences International Sàrl | Trial completion date: Jun 2022 --> Jun 2024
Clinical • Trial completion date
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RET (Ret Proto-Oncogene) • KIT (KIT proto-oncogene, receptor tyrosine kinase) • FGFR (Fibroblast Growth Factor Receptor)
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EGFR mutation • KIT mutation • RET mutation • FGFR mutation
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Iclusig (ponatinib)
over1year
Clinical • Trial primary completion date
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FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation
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Balversa (erdafitinib)
over1year
Landscape of FGF/FGFR Alterations in 12,372 Chinese Cancer Patients. (PubMed, J Cancer)
The microsatellite instability status was negatively associated with amplifications (p=0.0017). FGF/FGFR alterations were widely occurred in cancer patients, and the mutational landscape may contribute to the further study design and development of FGF/FGFR inhibitors.
Clinical • Journal
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MSI (Microsatellite instability) • FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation • FGF amplification
over1year
Pemigatinib, a potent inhibitor of FGFRs for the treatment of cholangiocarcinoma. (PubMed, Future Oncol)
Based on the results of FIGHT-202 trial, in April 2020 the US FDA approved the FGFR inhibitor pemigatinib in advanced previously treated cholangiocarcinoma patients with FGFR2 rearrangements, opening the way to targeted therapy in this disease. This review summarizes the body of evidence about the efficacy of pemigatinib in cholangiocarcinoma.
Journal
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FGFR2 (Fibroblast growth factor receptor 2)
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FGFR2 mutation • FGFR2 fusion • FGFR mutation
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Pemazyre (pemigatinib)
over1year
Mutation profiling of uterine cervical cancer patients treated with definitive radiotherapy. (PubMed, Gynecol Oncol)
FGFR mutations are associated with worse PFS in UCC patients treated with definitive radiotherapy. These results warrant further validation in prospective studies.
Clinical • Journal
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TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • FGFR3 (Fibroblast growth factor receptor 3) • FGFR1 (Fibroblast growth factor receptor 1) • NOTCH1 (Notch 1) • ARID1A (AT-rich interaction domain 1A) • FBXW7 (F-Box And WD Repeat Domain Containing 7) • FGFR4 (Fibroblast growth factor receptor 4) • EP300 (E1A binding protein p300)
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PIK3CA mutation • ARID1A mutation • FGFR3 mutation • FGFR mutation
over1year
[VIRTUAL] A randomized phase 2 study of erdafitinib (ERDA) versus intravesical chemotherapy (IC) in patients with high-risk non-muscle invasive bladder cancer (HR-NMIBC) with FGFR mutations or fusions, who recurred after Bacillus Calmette-Guérin (BCG) therapy (DGU 2020)
Cohort 1 (n = 240): high-grade disease Ta / T1 lesion (papillary only) with disease recurrence after BCG therapy will be randomized to ERDA or IC (gemcitabine / mitomycin C); Cohort 2 (n = 20): carcinoma in situ (CIS) with / without papillary disease to receive ERDA Cohort 3 (n = 20): marker lesion study in patients with intermediate-risk papillary disease only to receive ERDA. Patients will be enrolled at sites in ~ 14 countries. EudraCT: 2019-002449-39.
P2 data • Clinical
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FGFR2 (Fibroblast growth factor receptor 2) • FGFR3 (Fibroblast growth factor receptor 3) • FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation • FGFR fusion
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gemcitabine • Balversa (erdafitinib)
over1year
[VIRTUAL] FIND: Phase II study to evaluate the efficacy of Erdafitinib in patients with NSCLC and FGFR alterations (DGHO 2020)
"Oncogenic driver FGFR alterations are rare in NSCLC patients and require screening in large collaborative networks such as nNGM. Further thorough preclinical and clinical assessment is needed to identify NSCLC patients benefiting from FGFR inhibition."
P2 data • Clinical
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FGFR3 (Fibroblast growth factor receptor 3) • TACC3 (Transforming acidic coiled-coil containing protein 3) • FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation
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Balversa (erdafitinib)
over1year
[VIRTUAL] FIND: Phase II study to evaluate the efficacy of Erdafitinib in patients with NSCLC and FGFR alterations (DGHO 2020)
"Oncogenic driver FGFR alterations are rare in NSCLC patients and require screening in large collaborative networks such as nNGM. Further thorough preclinical and clinical assessment is needed to identify NSCLC patients benefiting from FGFR inhibition."
P2 data • Clinical
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FGFR3 (Fibroblast growth factor receptor 3) • TACC3 (Transforming acidic coiled-coil containing protein 3) • FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation
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Balversa (erdafitinib)
over1year
[VIRTUAL] FIND: Phase II study to evaluate the efficacy of Erdafitinib in patients with NSCLC and FGFR alterations (DGHO 2020)
"Oncogenic driver FGFR alterations are rare in NSCLC patients and require screening in large collaborative networks such as nNGM. Further thorough preclinical and clinical assessment is needed to identify NSCLC patients benefiting from FGFR inhibition."
P2 data • Clinical
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FGFR3 (Fibroblast growth factor receptor 3) • TACC3 (Transforming acidic coiled-coil containing protein 3) • FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation
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Balversa (erdafitinib)
over1year
[VIRTUAL] Novel therapeutic targets in cholangiocarcinoma: Beyond IDH (ILCA 2020)
Increasing evidence suggests that the TME of CCA may play a crucial role in promoting enhanced malignant behavior, response to therapy and onset of resistance. In this context, molecular signals deriving from tumor supporting stromal cells, such as activated stromal fibroblasts and inflammatory cells, are currently being explored as they may represent valuable alternative targets for more effective therapies.
FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation • FGFR fusion
over1year
Trametinib for the treatment of recurrent/progressive pediatric low-grade glioma. (PubMed, J Neurooncol)
Trametinib appears to be an effective treatment for patients with recurrent/progressive pLGG. The toxicities of this therapy warrant further investigation, with particular attention to the potential risk for intracranial hemorrhage. Early phase multi-institutional clinical trials are underway.
Clinical • Journal
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BRAF (B-raf proto-oncogene) • CDKN2A (Cyclin-dependent kinase inhibitor 2A) • NF1 (Neurofibromin 1) • FGFR (Fibroblast Growth Factor Receptor) • KIAA1549
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BRAF mutation • NF1 mutation • CDKN2A mutation • KIAA1549-BRAF fusion • BRAF fusion • FGFR mutation • miR138 underexpression + miR497 overexpression
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Mekinist (trametinib)
over1year
Enrollment change • Enrollment closed • Clinical
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FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation
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Balversa (erdafitinib)
over1year
Current and novel therapeutic opportunities for systemic therapy in biliary cancer. (PubMed, Br J Cancer)
Beyond targeted therapies, active research avenues explore the development of novel therapeutics that target the crosstalk between cancer and stroma, the cellular pathways involved in the regulation of cell death, the chemoresistance phenotype and the dysregulation of RNA. In this review, we discuss the therapeutic opportunities currently available in the management of BTC patients, and explore the strategies that can support the implementation of precision oncology in BTCs, including novel molecular targets, liquid biopsies and patient-derived predictive tools.
Review • Journal
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FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation
over1year
Clinical • P2 data
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FGFR3 (Fibroblast growth factor receptor 3) • FGFR (Fibroblast Growth Factor Receptor) • FGF (Fibroblast Growth Factor)
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FGFR mutation • FGFR fusion
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Balversa (erdafitinib)
over1year
Clinical • P2 data • IO biomarker
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FGFR3 (Fibroblast growth factor receptor 3) • FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation
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Balversa (erdafitinib)
over1year
FGFR2 (Fibroblast growth factor receptor 2) • FGFR1 (Fibroblast growth factor receptor 1) • FGFR (Fibroblast Growth Factor Receptor) • FGF (Fibroblast Growth Factor) • CSF1R (Colony stimulating factor 1 receptor)
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FGFR2 mutation • FGFR2 fusion • FGFR mutation • FGFR fusion • FGFR expression
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derazantinib (ARQ 087)
over1year
Brief Report: SWOG S1400D (NCT02965378), a Phase II Study of the Fibroblast Growth Factor Receptor Inhibitor AZD4547 in Previously-treated Patients with Fibroblast Growth Factor Pathway-Activated Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study). (PubMed, J Thorac Oncol)
AZD4547 had an acceptable safety profile but minimal activity in this predominantly FGFR 1/3 amplified cohort. Evaluation of other targeted agents in Lung-MAP is currently ongoing. ClinicalTrials.gov Identifier: NCT02965378.
Clinical • P2 data • Journal
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FGFR3 (Fibroblast growth factor receptor 3) • FGFR1 (Fibroblast growth factor receptor 1) • FGFR (Fibroblast Growth Factor Receptor) • FGF (Fibroblast Growth Factor)
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FGFR1 amplification • FGFR3 S249C • FGFR mutation • FGFR3 fusion • FGFR3 amplification
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ABSK091
over1year
Expression Atlas of FGF and FGFR Genes in Pancancer Uncovered Predictive Biomarkers for Clinical Trials of Selective FGFR Inhibitors. (PubMed, Biomed Res Int)
High positive FGFR1 or 3 expression ratios were predicted in cholangiocarcinoma (58%), followed by bladder cancer (42%), endometrial carcinoma (35%), and ovarian cancer (34%). FGFR expression was a promising predictive biomarker for FGFR inhibition response in clinical trials, and different combinations of FGFR genes should be used in screening for patients in certain tumor types.
Clinical • Journal • Pan Tumor
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FGFR1 (Fibroblast growth factor receptor 1)
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FGFR mutation • FGFR1 expression • FGFR expression
over1year
Molecular therapeutic targets in non-small cell lung cancer. (PubMed, Expert Rev Anticancer Ther)
Though next-generation tyrosine kinase inhibitors (TKIs) have been developed, the appropriate sequencing of these drugs is not clear. Evaluating combination therapies to prevent or delay the onset of resistance and understanding mechanisms of resistance are critical areas of emerging research.
Journal
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EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • FGFR (Fibroblast Growth Factor Receptor)
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KRAS mutation • EGFR mutation • HER-2 amplification • KRAS G12C • MET amplification • EGFR exon 20 insertion • RET mutation • RET rearrangement • KRAS G12 • KRAS amplification • EGFR exon 20 mutation • FGFR mutation
over1year
Macrophage correlates with immunophenotype and predicts anti-PD-L1 response of urothelial cancer. (PubMed, Theranostics)
M1 infiltration is a robust biomarker for immunotherapeutic response and immunophenotype determination in an mUC setting. Innate immunity activation involving macrophage polarization remodeling and anti-FGFR mutations may be promising strategies for synergy with anti-PD-L1 treatments and may help prolong the clinical survival of patients with mUC.
Journal • Tumor Mutational Burden • PD(L)-1 Biomarker
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TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • CD8 (cluster of differentiation 8) • FGFR (Fibroblast Growth Factor Receptor)
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PD-L1 expression • FGFR mutation
over1year
The future of bladder cancer therapy: Optimizing the inhibition of the fibroblast growth factor receptor. (PubMed, Cancer Treat Rev)
Recently, erdafitinib, a pan-FGFR inhibitor, was approved by the FDA in patients with metastatic BC who have progressed on platinum-based chemotherapy...Efficacy and safety data including insights from mechanism-based toxicity are reported for selected populations of metastatic BC with FGFR aberrations. Current strategies to managing resistance to anti-FGFR agents is addressed, and the importance of developing reliable biomarkers as the therapeutic landscape moves towards an individualized therapeutic approach.
Review • Journal
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FGFR (Fibroblast Growth Factor Receptor) • FGF (Fibroblast Growth Factor)
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FGFR mutation
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Balversa (erdafitinib)
over1year
Phase II Study of AZD4547 in Patients With Tumors Harboring Aberrations in the FGFR Pathway: Results From the NCI-MATCH Trial (EAY131) Subprotocol W. (PubMed, J Clin Oncol)
Preliminary signals of activity appeared to be limited to cancers harboring FGFR activating mutations and fusions, although AZD4547 did not meet the primary end point. Different FGFR somatic alterations may confer different levels of signaling potency and/or oncogene dependence.
Clinical • P2 data • Journal
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FGFR2 (Fibroblast growth factor receptor 2) • FGFR3 (Fibroblast growth factor receptor 3) • FGFR (Fibroblast Growth Factor Receptor) • FGF (Fibroblast Growth Factor)
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FGFR1 amplification • FGFR2 amplification • FGFR2 fusion • FGFR1 mutation • FGFR mutation • FGFR1 fusion • FGFR3 amplification
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ABSK091
over1year
[VIRTUAL] Genomic aberration of FGF/FGFR and genes related to primary resistance to FGFR inhibitor in urothelial carcinoma (AUA 2020)
The incidence of genomic FGF/FGFR aberration in urothelial carcinoma is approximately 41.0%. Of which, the frequency of genetic alteration related to resistance to FGFR inhibitor is practically 53.0%, including KRAS (6%), ERBB2 (12%), PIK3CA (14%) and TSC1 (10%). Source of Funding: No
Tumor Mutational Burden • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker
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HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • FGFR2 (Fibroblast growth factor receptor 2) • FGFR3 (Fibroblast growth factor receptor 3) • FGFR1 (Fibroblast growth factor receptor 1) • TACC3 (Transforming acidic coiled-coil containing protein 3) • FGFR4 (Fibroblast growth factor receptor 4) • TSC1 (TSC complex subunit 1) • FGF (Fibroblast Growth Factor)
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FGFR3 mutation • FGFR mutation • FGFR3 fusion • IKZF1 deletion + PAX5 deletion
over1year
[VIRTUAL] Landscape of FGFRactivating aberrations in Chinese non-small cell lung cancer (AACR-II 2020)
In addition, FGFR amplification was detected in 24 patients, with FGFR1 amplification being the most common event. Notably, FGFR oncogenic mutations, fusions, and gene amplifications were almost always mutually exclusive events.Conclusion We herein report an incidence of FGFR anomalies in a large Chinese NSCLC population, including mutations, gene amplifications, and previously characterized and novel FGFR fusions involving TACC3, INA, RAPGEFL1, and SLC20A2.
FGFR2 (Fibroblast growth factor receptor 2) • FGFR3 (Fibroblast growth factor receptor 3) • FGFR1 (Fibroblast growth factor receptor 1) • TACC3 (Transforming acidic coiled-coil containing protein 3) • FGFR4 (Fibroblast growth factor receptor 4) • FGF (Fibroblast Growth Factor)
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EGFR amplification • FGFR1 amplification • EGFR overexpression • FGFR1 overexpression • FGFR2 fusion • FGFR mutation • FGFR1 fusion
over1year
[VIRTUAL] Biochemical characterization of FGFR2-PPHLN1 and BCR-FGFR1, drivers of epithelial and hematological malignancies (AACR-II 2020)
Preliminary data suggests that transformed cells expressing either FGFR2-PPHLN1, or kinase activated FGFR2(N549K)-PPHLN1, may be sensitive to treatment with FGFR inhibitor TAS-120, suggesting that TAS-120 treatment could be beneficial for patients with FGFR2-PPHLN1 driven ICC. Transformed cells expressing BCR-FGFR1 are sensitive to the Hsp90 inhibitor, Ganetespib, and also respond to combined treatment with Ganetespib and FGFR inhibitor BGJ398, suggesting novel clinical treatment options for patients positive for this fusion. Collectively, we show that the tyrosine kinase activity provided by FGFR2 or FGFR1, respectively is required for the biological activity of these fusion proteins, and we establish novel treatment options for patients with FGFR2-PPHLN1 or BCR-FGFR1 driven malignancies.
FGFR2 (Fibroblast growth factor receptor 2) • FGFR1 (Fibroblast growth factor receptor 1) • FGF (Fibroblast Growth Factor)
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FGFR2 mutation • FGFR2 fusion • FGFR2 N549K • FGFR mutation • FGFR1 fusion • FGFR1 expression
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Truseltiq (infigratinib) • futibatinib (TAS 120) • ganetespib (ADX-1612)
over1year
[VIRTUAL] Clinical outcome in terms of survival and treatment response of patients with metastatic urothelial carcinoma harboring FGFR alterations compared to wild-type tumors. (ASCO 2020)
FGFR is a relatively common molecular alteration in UC. Patients harboring a FGFR alteration present a better prognosis than wild type tumors. Clinical benefit with chemotherapy and CPIs was similar in both populations.
Clinical • Clinical data
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FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation
over1year
[VIRTUAL] Genomic landscape of FGF/FGFR pathway alternations across 12,372 pan-cancer patients. (ASCO 2020)
Our study investigated the molecular landscape of FGF/FGFR pathway alternations and the interplay between co-occurrence and mutual exclusivity between pathway genes in a large pan-cancer cohort. FGF/FGFR pathway mutations occurs in a variety of solid tumors, indicating that these patients may benefit from FGFR inhibitors. Research Funding: None
Clinical • Pan tumor
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MSI (Microsatellite instability) • FGFR2 (Fibroblast growth factor receptor 2) • FGFR3 (Fibroblast growth factor receptor 3) • FGFR1 (Fibroblast growth factor receptor 1) • FGFR (Fibroblast Growth Factor Receptor) • FGFR4 (Fibroblast growth factor receptor 4) • FGF (Fibroblast Growth Factor)
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FGFR2 fusion • FGFR mutation • FGFR1 fusion • FGF amplification
over1year
[VIRTUAL] Safety and efficacy of pemigatinib plus pembrolizumab combination therapy in patients (pts) with advanced malignancies: Results from FIGHT-101, an open-label phase I/II study. (ASCO 2020)
PEMI + PEMBRO combination therapy was tolerable with no new safety signals, and demonstrated preliminary antitumor activity in pts with advanced malignancies including those with FGF/FGFR alterations. Research Funding: Incyte Corporation
Clinical • P1/2 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
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FGFR (Fibroblast Growth Factor Receptor) • FGF (Fibroblast Growth Factor)
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FGFR mutation
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Keytruda (pembrolizumab) • Pemazyre (pemigatinib)
almost2years
Clinical • New trial • IO Companion diagnostic • IO biomarker
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PD-L1 (Programmed death ligand 1) • FGFR (Fibroblast Growth Factor Receptor)
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PD-L1 expression • FGFR mutation
almost2years
Enrollment open • Clinical
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FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation • FGFR fusion
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gemcitabine • Balversa (erdafitinib) • mitomycin
2years
Clinical • Trial completion
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FGF (Fibroblast Growth Factor)
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FGFR mutation • FGFR expression
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rogaratinib (BAY 1163877)
2years
Enrollment open • Clinical
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FGFR (Fibroblast Growth Factor Receptor)
|
FGFR mutation • FGFR fusion
|
Balversa (erdafitinib)
2years
New P2 trial • Clinical
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FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation • FGFR fusion
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gemcitabine • Balversa (erdafitinib) • mitomycin
over2years
New P2 trial • Clinical
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FGFR (Fibroblast Growth Factor Receptor)
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FGFR mutation • FGFR fusion
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Balversa (erdafitinib)
over2years
Trial completion date • Clinical
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FGFR (Fibroblast Growth Factor Receptor)
|
FGFR mutation
|
Balversa (erdafitinib)
over2years
Trial completion date • Clinical
|
FGFR (Fibroblast Growth Factor Receptor)
|
FGFR mutation
|
Balversa (erdafitinib)
almost3years
Trial completion date • Trial primary completion date • Clinical
|
FGFR (Fibroblast Growth Factor Receptor)
|
FGFR mutation
|
Balversa (erdafitinib)
over3years
Trial completion date • Clinical
|
FGFR (Fibroblast Growth Factor Receptor)
|
FGFR mutation
|
Balversa (erdafitinib)