News - PIK3CA mutation

22h

Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors (clinicaltrials.gov)

P1, N=63, Recruiting, Regor Pharmaceuticals Inc. | Not yet recruiting --> Recruiting

22 hours ago

Enrollment open • First-in-human

PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)

PIK3CA mutation

24h

A Real-World Study of Inavolisib in Patients With HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer (clinicaltrials.gov)

P=N/A, N=100, Not yet recruiting, xuliang

24 hours ago

New trial • Real-world evidence

HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)

HER-2 negative • PIK3CA mutation

Itovebi (inavolisib)

Multiomics Biomarkers for Differential Diagnosis of Pleural Effusion: Integration of Proteomic Markers and Single-Cell Transcriptomics. (PubMed, Hum Mutat)

The sequential multibiomarker algorithm achieved 96.5% sensitivity and 98.7% specificity for malignant PE detection, with 85.3% overall three-way classification accuracy. Multiomics integration combining proteomic biomarkers with single-cell immune profiling and genomic mutation characterization achieves high diagnostic accuracy for pleural effusion while revealing disease-specific immune mechanisms and mutation-driven therapeutic opportunities.

1 day ago

Journal • Pleural effusion

EGFR (Epidermal growth factor receptor) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • CD8 (cluster of differentiation 8) • CEACAM5 (CEA Cell Adhesion Molecule 5) • KRT19 (Keratin 19)

TP53 mutation • EGFR mutation • PIK3CA mutation

Multi-Machine Learning Elucidates Clinical Potential of Epithelial-Mesenchymal Transition-Associated Long Non-Coding RNAs in Breast Cancer Progression. (PubMed, Biotechnol J)

And neutrophils were exclusively observed within the tumor microenvironment (TME) of BMS. All these findings emphasized EALs' value in revolutionizing clinical decision-making for personalized treatment strategies in BRCA cases.

1 day ago

Journal • BRCA Biomarker • IO biomarker

TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • BRCA (Breast cancer early onset) • CDH1 (Cadherin 1) • MIR205 (MicroRNA 205)

TP53 mutation • PIK3CA mutation

The use of cell-free DNA (cfDNA)/circulating tumor DNA (ctDNA) to guide treatment selection in metastatic breast cancer. (PubMed, Pharmacogenomics)

Actionable genomic mutations such as PIK3CA, ESR1, ERBB2, BRCA1/2, and AKT/PTEN are reviewed in relation to their corresponding therapeutic agents. Implementation challenges, pre-analysis pitfalls, uncertain sampling cadence, cost barriers, and disparities in access are discussed, along with potential solutions.

1 day ago

Review • Journal • BRCA Biomarker • Circulating tumor DNA

HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • PTEN (Phosphatase and tensin homolog)

BRCA2 mutation • BRCA1 mutation • PIK3CA mutation • HER-2 mutation • PTEN mutation

Integrating PIK3CA Testing into Clinical Practice for Advanced HR+/HER2- Breast Cancer: An Expert Consensus. (PubMed, Breast)

This consensus document provides operational and interpretative guidelines aimed at standardizing PIK3CAtesting and assessing related genes in clinical practice. These recommendations promote a harmonized approach to patient care, in line with the latest scientific evidence.

3 days ago

Review • Journal

HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)

HER-2 negative • PIK3CA mutation

Piqray (alpelisib) • Itovebi (inavolisib)

A global clinicopathologic and molecular portrait of spindle cell/sclerosing rhabdomyosarcoma with emphasis on retroperitoneal cases. (PubMed, Front Oncol)

However, these frequency estimates are derived from a subset of tested cases and should be interpreted within the context of variable molecular data reporting across studies. These findings highlight the potential value molecularly guided treatment strategies in this rare and lethal disease subtype.

5 days ago

Journal

PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • EWSR1 (EWS RNA Binding Protein 1) • FUS (FUS RNA Binding Protein) • TFCP2 (Transcription Factor CP2) • MYOD1 (Myogenic Differentiation 1)

PIK3CA mutation

Bifocal cerebellar liponeurocytoma with atypical features: A case report and a literature review. (PubMed, Clin Neuropathol)

The patient has been under observation without any further intervention for 70 months since diagnosis, with no evidence of disease recurrence. In addition to the rarity of cLNC, this is a unique case in terms of bifocality, anaplastic histology, and the described genetic abnormalities.

5 days ago

Journal

HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha)

TP53 mutation • PIK3CA mutation • HER-2 mutation

PIKALO-2: A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) (clinicaltrials.gov)

P3, N=920, Recruiting, Eli Lilly and Company | N=274 --> 920

5 days ago

Enrollment change • Trial initiation date

HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor)

ER positive • PIK3CA mutation • PGR positive

Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • letrozole • anastrozole • exemestane • tersolisib (LY4064809)

Economic Evaluation of Inavolisib Combined With Palbociclib-Fulvestrant for PIK3CA-Mutated, HR+/HER2- Advanced Breast Cancer in USA. (PubMed, Technol Cancer Res Treat)

To achieve cost-effectiveness at WTP thresholds of $100,000, $150,000, and $200,000 per QALY, the per-cycle price of inavolisib would need to be reduced to 59.5%, 72.0%, and 86.5% of its current price, respectively.ConclusionFor patients with PIK3CA-mutated HR+/HER2- ABC, the inavolisib regimen is not cost-effective in the U.S. healthcare setting. Negotiating price reductions and adjusting decision thresholds based on patient characteristics may be viable strategies to meet the extensive treatment demand in the U.S.

6 days ago

Journal • HEOR

HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)

EGFR mutation • HR positive • HER-2 negative • PIK3CA mutation • EGFR positive

Ibrance (palbociclib) • fulvestrant • Itovebi (inavolisib)

Clinicopathologic features of KRAS G12C-mutated non-small cell lung carcinomas:insights from 279 retrospective cases. (PubMed, Virchows Arch)

KRAS G12C-mutated NSCLC is clinically aggressive and frequently shows solid growth with rhabdoid, plasmacytoid, or SCC-like morphology, which may lead to misclassification and missed genetic testing. Immunohistochemistry and molecular profiling are essential for accurate classification and enabling targeted therapy.

7 days ago

Retrospective data • Journal • PD(L)-1 Biomarker • IO biomarker

PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • FGFR3 (Fibroblast growth factor receptor 3) • STK11 (Serine/threonine kinase 11) • NRG1 (Neuregulin 1) • TACC3 (Transforming acidic coiled-coil containing protein 3) • CTNNB1 (Catenin (cadherin-associated protein), beta 1) • NKX2-1 (NK2 Homeobox 1) • GNAS (GNAS Complex Locus) • TP63 (Tumor protein 63) • NAPSA (Napsin A Aspartic Peptidase)

PD-L1 expression • TP53 mutation • KRAS mutation • KRAS G12C • BRAF mutation • PIK3CA mutation • STK11 mutation • FGFR2 mutation • MET mutation • NRG1 fusion • KRAS G12

PIK3CA mutant cervical cancer is selectively suppressed by PI3Kα inhibition (Alpelisib/BYL-719 and Inavolisib/GDC-0077) and cooperates with HPV directed T cell therapy. (PubMed, Neoplasia)

These findings identify actionable molecular subtypes of cervical cancer and support targeting PI3Kα in PIK3CA-mutant tumors. Moreover, combining PI3K inhibition with antigen-specific immunotherapy represents a promising strategy to improve outcomes in advanced HPV16-associated cervical cancer.

8 days ago

Journal • PD(L)-1 Biomarker • IO biomarker

EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • YAP1 (Yes associated protein 1)

EGFR mutation • PIK3CA mutation • HLA-A*02 positive

Piqray (alpelisib) • Itovebi (inavolisib)