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    BIOMARKER:

    PIK3CA G1049R

    i
    Other names: PIK3CA, Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha, Phosphoinositide-3-kinase, catalytic, alpha polypeptide, Serine/threonine protein kinase PIK3CA, PtdIns-3-kinase subunit P110-alpha, PI3K-alpha, Phosphatidylinositol-4,5-bisphosphate 3-kinase 110 KDa catalytic subunit alpha, Phosphatidylinositol 3-kinase, Catalytic, 110-KD, alpha, PI3-kinase P110 subunit alpha, PI3-kinase subunit alpha, PtdIns-3-kinase subunit alpha, PI3Kalpha, P110alpha, PI3K
    Entrez ID:
    5290
    Related biomarkers:
    Expression
    Mutation
    CNA
    Others
    3ms
    A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer (clinicaltrials.gov)
    P2, N=51, Recruiting, GOG Foundation | Not yet recruiting --> Recruiting
    Enrollment open
    |
    ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MSI (Microsatellite instability)
    |
    PIK3CA mutation • PIK3CA E545 • PIK3CA E542 • PIK3CA M1043I • PIK3CA C420R • PIK3CA N345K • PIK3CA G1049R • PIK3CA Q546
    |
    Piqray (alpelisib) • fulvestrant
    over1year
    A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer (clinicaltrials.gov)
    P2, N=51, Not yet recruiting, GOG Foundation | Trial completion date: Apr 2025 --> Apr 2026 | Initiation date: Apr 2022 --> Jan 2023 | Trial primary completion date: Aug 2024 --> Apr 2025
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MSI (Microsatellite instability)
    |
    ER positive • PIK3CA mutation • PIK3CA E545 • PIK3CA E542 • PIK3CA M1043I • PIK3CA C420R • PIK3CA N345K • PIK3CA G1049R • PIK3CA Q546
    |
    Piqray (alpelisib) • fulvestrant
    2years
    Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer (clinicaltrials.gov)
    P2, N=11, Completed, NRG Oncology | Active, not recruiting --> Completed
    Trial completion
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    PIK3CA mutation • PIK3CA H1047R • PIK3CA E545K • PIK3CA E545 • PIK3CA E542 • PIK3CA H1047L • PIK3CA M1043I • PIK3CA C420R • PIK3CA E545A • PIK3CA N345K • PIK3CA E545G • PIK3CA E545X • PIK3CA G1049R • PIK3CA H1047X • PIK3CA Q546 • PIK3CA Q546K • PIK3CA Q546R
    |
    Aliqopa (copanlisib)
    over2years
    A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer (clinicaltrials.gov)
    P2, N=51, Not yet recruiting, GOG Foundation
    New P2 trial
    |
    ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MSI (Microsatellite instability)
    |
    ER positive • PIK3CA mutation • PIK3CA E545 • PIK3CA E542 • PIK3CA M1043I • PIK3CA C420R • PIK3CA N345K • PIK3CA G1049R • PIK3CA Q546
    |
    Piqray (alpelisib) • fulvestrant
    almost3years
    Mutational Landscape of PI3K-AKT-mTOR Pathway in Breast Cancer: Implications for Targeted Therapeutics. (PubMed, J Cancer)
    Our study reveals the heterogeneity in PI3K-AKT-mTOR pathway among the breast cancer molecular subtypes in our cohort. Moreover, the number and specific sites of PIK3CA mutations have distinct prognostic impact.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • AKT1 (V-akt murine thymoma viral oncogene homolog 1) • PIK3R1 (Phosphoinositide-3-Kinase Regulatory Subunit 1) • PIK3CG (Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Gamma)
    |
    PIK3CA mutation • PIK3CA H1047R • PTEN mutation • PIK3CA E545K • PIK3CA E542K • MTOR mutation • PIK3CA E545 • PIK3CA E542 • PIK3CA H1047L • PIK3CA C420R • PIK3CA N345K • PIK3CA D350G • PIK3CA E545G • PIK3CA G1049R
    3years
    [VIRTUAL] Real-world (rw) clinical outcomes on alpelisib (ALP) in patients (pts) with breast cancer (BC) and PIK3CA mutations (PIK3CAm). (ASCO 2021)
    Cohort A: HR+/HER2- pts receiving fulvestrant (FUL) alone (n = 124) or ALP/FUL (n = 111) in treatment line ≥2L were considered in survival analysis . This study validates the activity of ALP among a diverse real world population, showing pts with PIK3CA mutations have longer rwPFS on ALP/FUL than FUL alone . Pts with SOLAR1m were more likely to be treated with ALP- and tended to be treated in earlier line setting- than pts with OTHERm . No consistent effect in a small subset of pts with OTHERm treated with ALP was observed, but there is evidence that OTHERm may differ in their degree of PI3K activation, oncogenicity, and ALP sensitivity .
    Real-world evidence • Clinical data • Clinical
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PIK3R1 (Phosphoinositide-3-Kinase Regulatory Subunit 1)
    |
    HER-2 negative • PIK3CA mutation • PIK3CA N345K • PIK3CA Q75E • PIK3CA G1049R • PIK3CA G106_108del • PIK3CA Q546 • PIK3CA Q546K • PIK3CA R38C
    |
    Piqray (alpelisib) • fulvestrant
    3years
    [VIRTUAL] A comprehensive characterization of hyper-morph, hypo-morph, and neo-morph mutations in cancer (AACR 2021)
    Further validation of these mutations using PIK3CA reporter assays led to the identification of several significant hypo-morphic signals in TP53 mutant samples. We defined this phenomenon as mutational mimicry (i.e. mutations in proteins mimicking those in established oncogenes) and we propose it as a tool for predicting tumor sensitivity/resistance to drugs.
    BRCA Biomarker
    |
    TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • BRCA (Breast cancer early onset)
    |
    TP53 mutation • PIK3CA mutation • PIK3CA E545K • PIK3CA E545 • PIK3CA H1047 • BRCA mutation • PIK3CA E542 • PIK3CA G1049R • PIK3CA Q546 • PIK3CA Q546K