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    BIOMARKER:

    FGFR amplification

    i
    Other names: FGFR, Fibroblast Growth Factor Receptor
    Related biomarkers:
    Expression
    Mutation
    Fusion
    Others
    4d
    Fulvestrant, Palbociclib and Erdafitinib in ER+/HER2-/FGFR-amplified Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=35, Completed, Vanderbilt-Ingram Cancer Center | Active, not recruiting --> Completed | Trial completion date: Sep 2024 --> Mar 2024
    Trial completion • Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • FGFR2 (Fibroblast growth factor receptor 2) • FGFR1 (Fibroblast growth factor receptor 1) • FGFR4 (Fibroblast growth factor receptor 4) • FGF23 (Fibroblast Growth Factor 23)
    |
    HER-2 negative • FGFR1 amplification • FGFR3 amplification • FGFR4 amplification • FGFR amplification
    |
    Ibrance (palbociclib) • Balversa (erdafitinib) • fulvestrant
    7ms
    Phase II Study of Erdafitinib in Patients With Tumors With FGFR Amplifications: Results From the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol K1. (PubMed, JCO Precis Oncol)
    Erdafitinib did not meet its primary end point of efficacy as determined by ORR in treatment-refractory solid tumors harboring FGFR1-4 amplifications. Our findings support that rearrangements and gene mutations, but not amplifications, of FGFR remain the established FGFR alterations with approved indications for FGFR inhibition.
    P2 data • Journal
    |
    FGFR (Fibroblast Growth Factor Receptor)
    |
    FGFR1 amplification • FGFR mutation • FGFR amplification
    |
    Balversa (erdafitinib)
    8ms
    Paradoxical cancer cell proliferation after FGFR inhibition through decreased p21 signaling in FGFR1-amplified breast cancer cells. (PubMed, Breast Cancer Res)
    Overall, our findings reveal a divergence in FGFR signaling, transitioning from a proliferative to stemness state driven by activation of JAK-STAT signaling and modulation of p21 levels. Activation of these divergent signaling pathways in FGFR amplified cancer cells and paradoxical growth effects highlight a challenge in the use of FGFR inhibitors in cancer treatment.
    Journal
    |
    FGFR1 (Fibroblast growth factor receptor 1) • FGF2 (Fibroblast Growth Factor 2) • CDKN1A (Cyclin-dependent kinase inhibitor 1A)
    |
    FGFR1 amplification • FGFR1 expression • FGFR amplification
    9ms
    Fulvestrant, Palbociclib and Erdafitinib in ER+/HER2-/FGFR-amplified Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=35, Active, not recruiting, Vanderbilt-Ingram Cancer Center | Trial completion date: Dec 2023 --> Sep 2024
    Trial completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • FGFR2 (Fibroblast growth factor receptor 2) • FGFR1 (Fibroblast growth factor receptor 1) • FGFR4 (Fibroblast growth factor receptor 4) • FGF23 (Fibroblast Growth Factor 23)
    |
    HER-2 negative • FGFR1 amplification • FGFR3 amplification • FGFR4 amplification • FGFR amplification
    |
    Ibrance (palbociclib) • Balversa (erdafitinib) • fulvestrant
    1year
    EMSY amplification co-occurs with FGF/FGFR axis amplification in Metastatic Breast Cancer (SABCS 2023)
    Amplification of EMSY has been mostly reported in ovarian (~17%) and sporadic breast cancers (~13%). EMSY has been reported to behave as an oncogene and a transcriptional repressor. It is well known that it can interact with the BRCA2 protein and potentially contributes to the "BRCAness" of tumors harboring its amp.
    BRCA Biomarker • Metastases
    |
    TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • BRCA2 (Breast cancer 2, early onset) • FGFR1 (Fibroblast growth factor receptor 1) • FGFR (Fibroblast Growth Factor Receptor) • CCND1 (Cyclin D1) • FGF19 (Fibroblast growth factor 19) • FGF3 (Fibroblast growth factor 3) • FGF4 (Fibroblast growth factor 4) • EMSY (EMSY Transcriptional Repressor BRCA2 Interacting) • ZNF703 (Zinc Finger Protein 703)
    |
    TP53 mutation • PIK3CA mutation • EMSY mutation • FGFR amplification
    over1year
    Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies (clinicaltrials.gov)
    P1/2, N=30, Recruiting, Effector Therapeutics | N=228 --> 30 | Trial completion date: Sep 2023 --> Mar 2025 | Trial primary completion date: Jul 2023 --> Dec 2024
    Enrollment change • Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase) • FGFR (Fibroblast Growth Factor Receptor) • CCND1 (Cyclin D1)
    |
    KRAS mutation • KRAS G12C • HER-2 negative • KRAS G12 • FGFR amplification
    |
    Herceptin (trastuzumab) • Verzenio (abemaciclib) • Lumakras (sotorasib) • fulvestrant • zotatifin (eFT226)
    over1year
    Phase 2 study of futibatinib in patients with specific FGFR aberrations: Activity in patients with gastric or gastroesophageal junction cancer harboring FGFR2 amplification (ESMO-GI 2023)
    Futibatinib demonstrated modest antitumor activity in heavily pretreated patients with advanced or metastatic gastric or GEJ cancer harboring FGFR2 amplification, with a predictable and manageable safety profile. No new safety signals were observed.
    Clinical • P2 data
    |
    FGFR2 (Fibroblast growth factor receptor 2)
    |
    FGFR2 fusion • FGFR2 amplification • FGFR amplification
    |
    Lytgobi (futibatinib)
    over1year
    Efficacy and safety of futibatinib for refractory advanced solid malignancies with FGFR alterations identified in circulating tumor DNA: TiFFANY, A GOZILA-affiliated Trial. (ASCO 2023)
    Futibatinib demonstrated promising efficacy in refractory advanced solid malignancies with FGFR alterations in ctDNA with an acceptable toxicity profile. Oncogenic co-alterations detected by ctDNA genotyping may predict primary resistance. Clinical trial information: JapicCTI-194624.
    Clinical • Circulating tumor DNA • Metastases
    |
    FGFR (Fibroblast Growth Factor Receptor) • PI3K (Phosphoinositide 3-kinases)
    |
    FGFR mutation • FGFR fusion • FGFR amplification
    |
    Lytgobi (futibatinib)
    almost2years
    Fulvestrant, Palbociclib and Erdafitinib in ER+/HER2-/FGFR-amplified Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=35, Active, not recruiting, Vanderbilt-Ingram Cancer Center | Trial completion date: Dec 2022 --> Dec 2023
    Trial completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • FGFR (Fibroblast Growth Factor Receptor)
    |
    HER-2 negative • FGFR amplification
    |
    Ibrance (palbociclib) • Balversa (erdafitinib) • fulvestrant