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    BIOMARKER:

    PIK3CA mutation + PTEN mutation

    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, PTEN, Phosphatase and
    Entrez ID:
    5290; 5728
    Related biomarkers:
    Expression
    Mutation
    CNA
    Others
    1year
    PIK3CA mutations in endometrial cancer: a pre-planned biomarker analysis from the phase II MITO END-3 study of carboplatin and paclitaxel with or without avelumab in advanced or recurrent endometrial cancer (AIOM 2024)
    The frequent alterations of the PI3K pathway in gynecological cancers could emerge as new treatment target. Our data confirm the high frequency of PIK3CA mutations establishing EC as an ideal candidate for testing of PI3K inhibitors regardless of the TCGA classification. Moreover, these data confirm that other targetable mutations are present also in MSS EC group thus suggesting that new target agents should be explored.
    P2 data • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MSI (Microsatellite instability) • PTEN (Phosphatase and tensin homolog) • ARID1A (AT-rich interaction domain 1A) • POLE (DNA Polymerase Epsilon)
    |
    TP53 mutation • MSI-H/dMMR • PIK3CA mutation • TP53 wild-type • PIK3CA H1047R • PTEN mutation • ARID1A mutation • POLE mutation • PIK3CA E545K • PIK3CA E545 • PIK3CA E542 • PIK3CA H1047L • PIK3CA mutation + PTEN mutation • PIK3CA C420R • PIK3CA E545A • PIK3CA E545G • PIK3CA Q546 • PIK3CA Q546R
    |
    FoundationOne® CDx
    |
    carboplatin • paclitaxel • Bavencio (avelumab)
    1year
    Efficacy of trastuzumab deruxtecan (T-DXd) in patients with metastatic lobular breast cancer with or without HER2 mutations: the MSKCC experience (SABCS 2024)
    The SUMMIT trial demonstrated meaningful activity of neratinib + fulvestrant + trastuzumab in patients with HR+, HER2 non-amplified, HER2-mutant MBC. In patients with mILC and HER2 mutation, there was a trend toward longer TTP with T-DXd. Genomic data could aid in prognostication in patients with mILC treated with T-DXd. These findings warrant confirmation in larger cohorts.
    Clinical • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog)
    |
    HER-2 negative • PIK3CA mutation • HER-2 mutation • HER-2 expression • PTEN mutation • PIK3CA mutation + PTEN mutation • PIK3CA mutation + AKT1 mutation + PTEN mutation
    |
    MSK-IMPACT
    |
    Nerlynx (neratinib) • Enhertu (fam-trastuzumab deruxtecan-nxki) • fulvestrant
    1year
    Correlation of clinical, genetic and transcriptomic traits with PD-L1 positivity in TNBC patients (ESMO-IO 2024)
    Most DEGs were involved in the neuroactive ligand-receptor interactions, calcium, cAMP and cell adhesion signalling pathways. Immune, chemokine and JAK-STAT signalling pathways were positively enriched in PD-L1-high tumours.Conclusions This integrative analysis of clinical, genetic, transcriptomic and immunohistochemical data revealed differences in mutational signatures and gene expression patterns between PD-L1-high and -low TNBC tumours.
    Clinical • Tumor mutational burden • PD(L)-1 Biomarker • BRCA Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • BRCA1 (Breast cancer 1, early onset) • PTEN (Phosphatase and tensin homolog) • RB1 (RB Transcriptional Corepressor 1) • JAK2 (Janus kinase 2) • IFNG (Interferon, gamma) • STAT1 (Signal Transducer And Activator Of Transcription 1)
    |
    PD-L1 expression • TP53 mutation • BRCA1 mutation • PIK3CA mutation • PTEN mutation • TMB-L • PIK3CA mutation + PTEN mutation • PD-L1 negative + TMB-L
    |
    PD-L1 IHC 22C3 pharmDx
    1year
    A071401: Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients with Progressive Meningiomas (clinicaltrials.gov)
    P2, N=124, Recruiting, Alliance for Clinical Trials in Oncology | Trial completion date: Oct 2024 --> Jan 2028 | Trial primary completion date: Oct 2024 --> Jan 2026
    Trial completion date • Trial primary completion date
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • AKT1 (V-akt murine thymoma viral oncogene homolog 1) • CCND1 (Cyclin D1) • CCNE1 (Cyclin E1) • PTCH1 (Patched 1) • CDK4 (Cyclin-dependent kinase 4) • NF2 (Neurofibromin 2) • SMO (Smoothened Frizzled Class Receptor) • CDK6 (Cyclin-dependent kinase 6) • CCND2 (Cyclin D2) • CCND3 (Cyclin D3)
    |
    PIK3CA mutation • PTEN mutation • CDKN2A mutation • PTCH1 mutation • NF2 mutation • AKT1 mutation • SMO mutation • PIK3CA mutation + PTEN mutation • CDK4 mutation
    |
    Verzenio (abemaciclib) • Truqap (capivasertib) • Erivedge (vismodegib) • GSK2256098
    1year
    MET and concomitant mutations in pulmonary adenocarcinomas (ECP 2024)
    Oncogenic activation of genes-drivers are responsible for resistance mechanisms either understood has resistance to METtargeted therapies and as primary resistance. Recently it has been reported that PI3K pathway alteration is common in concomitancy with METex14 and believed that confers primary resistance to MET TKI. Early identification of alterations in MET kinase domain at diagnosis, is crucial for understanding progression and resistance mechanism, to develop novel therapies or to design treatment strategies in order to improve patient outcomes.
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MET (MET proto-oncogene, receptor tyrosine kinase) • PTEN (Phosphatase and tensin homolog) • SMO (Smoothened Frizzled Class Receptor)
    |
    TP53 mutation • KRAS mutation • EGFR mutation • HER-2 amplification • PIK3CA mutation • HER-2 mutation • PTEN mutation • MET exon 14 mutation • ALK mutation • MET mutation • PD-L1 amplification • SMO mutation • PIK3CA mutation + PTEN mutation
    |
    Oncomine Precision Assay
    1year
    Molecular alterations of breast carcinoma: a single-centre experience (ECP 2024)
    Due to the majority of cases in our study being constituted of triple-negative cases, TP53 mutation, which is reported to be more common in these cases in the literature, was observed frequently. Most of the mutations we detected in our study have been reported to be associated with prognostic, predictive, and drug resistance implications, making their identification in breast tumours significant.
    Clinical • BRCA Biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • BRCA1 (Breast cancer 1, early onset) • MSI (Microsatellite instability) • PTEN (Phosphatase and tensin homolog) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • AKT1 (V-akt murine thymoma viral oncogene homolog 1) • BRCA (Breast cancer early onset) • CDH1 (Cadherin 1)
    |
    TP53 mutation • KRAS mutation • BRCA1 mutation • PIK3CA mutation • PTEN mutation • CDH1 mutation • PIK3CA mutation + PTEN mutation
    |
    BRCA MASTR Plus Dx
    over1year
    Superselective Intra-arterial Cerebral Infusion of Temsirolimus in HGG (clinicaltrials.gov)
    P1, N=12, Recruiting, Nader Sanai | Trial completion date: Apr 2025 --> Apr 2026 | Trial primary completion date: Apr 2024 --> Apr 2025
    Trial completion date • Trial primary completion date
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • mTOR (Mechanistic target of rapamycin kinase) • PIK3R1 (Phosphoinositide-3-Kinase Regulatory Subunit 1) • PIK3C2B (Phosphatidylinositol-4-Phosphate 3-Kinase Catalytic Subunit Type 2 Beta)
    |
    PIK3CA mutation • MTOR mutation • PIK3CA mutation + PTEN mutation • PIK3R1 mutation
    |
    Torisel (temsirolimus)
    over1year
    CLINICAL AND BIOLOGICAL SIGNIFICANCE OF T-CELL RECEPTOR REPERTOIRE IN PATIENTS WITH BREAST CANCER (GBCC 2024)
    These results demonstrate that the TCR repertoire is associated with characteristics, genetic alterations, and clinical outcomes. Monitoring changes in the TCR repertoire may serve as a prognostic biomarker for breast cancer patients.
    Clinical • IO biomarker
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • HRD (Homologous Recombination Deficiency) • PALB2 (Partner and localizer of BRCA2)
    |
    PIK3CA mutation • PIK3CA H1047R • PTEN mutation • PALB2 mutation • PIK3CA H1047L • PIK3CA mutation + PTEN mutation
    |
    Oncomine™ Comprehensive Assay v3M • Oncomine™ TCR Beta-LR Assay
    over1year
    Trametinib and Trifluridine and Tipiracil Hydrochloride in Treating Patients With Colon or Rectal Cancer That is Advanced, Metastatic, or Cannot Be Removed by Surgery (clinicaltrials.gov)
    P1, N=26, Completed, City of Hope Medical Center | Active, not recruiting --> Completed | Trial completion date: Dec 2023 --> Jul 2023 | Trial primary completion date: Dec 2023 --> Jul 2023
    Trial completion • Trial completion date • Trial primary completion date • Combination therapy • Surgery • Metastases
    |
    BRAF (B-raf proto-oncogene) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog)
    |
    BRAF mutation • PIK3CA mutation • BRAF wild-type • RAS mutation • RAS wild-type • RAS wild-type + BRAF wild-type • PIK3CA mutation + PTEN mutation
    |
    Mekinist (trametinib) • Lonsurf (trifluridine/tipiracil)
    over1year
    Comprehensive Analysis Identifies Variability in PI3K Pathway Alterations in Triple-Negative Breast Cancer Subtypes. (PubMed, JCO Precis Oncol)
    PI3K pathway alteration can affect response to NAT in TNBC, and targeted agents may improve outcomes, particularly in patients with M and LAR TNBC.
    Journal
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • AR (Androgen receptor)
    |
    PIK3CA mutation • PIK3CA mutation + PTEN mutation
    almost2years
    Tumor Microenvironment and Genomic Profiling of Squamous Cell Carcinomas of the Breast (USCAP 2024)
    About half of the breast SCCs exhibited high sTILs and positive PD-L1 expression, which indicated the potential opportunity for immunotherapy. Genomic profile revealed clinically meaningful alterations that might guide targeted treatment decisions in SCC patients.
    Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • PTEN (Phosphatase and tensin homolog) • TERT (Telomerase Reverse Transcriptase) • PIK3R1 (Phosphoinositide-3-Kinase Regulatory Subunit 1)
    |
    PD-L1 expression • TP53 mutation • TMB-H • PIK3CA mutation • PTEN deletion • PTEN mutation • PD-L1 negative • TERT mutation • PIK3CA mutation + PTEN mutation • PIK3R1 mutation • TERT promoter mutation
    |
    PD-L1 IHC 22C3 pharmDx
    almost2years
    Evaluation of potential biomarkers for lenvatinib plus pembrolizumab among patients with advanced endometrial cancer: results from Study 111/KEYNOTE-146. (PubMed, J Immunother Cancer)
    This analysis demonstrated efficacy for lenvatinib plus pembrolizumab regardless of biomarker status. Results from this study do not support clinical utility of the evaluated biomarkers. Further investigation of biomarkers for this regimen is warranted.
    Journal • Tumor mutational burden • PD(L)-1 Biomarker • Metastases
    |
    TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • PTEN (Phosphatase and tensin homolog)
    |
    TP53 mutation • PIK3CA mutation • PTEN deletion • PTEN mutation • PIK3CA mutation + PTEN mutation
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib)