PIK3CA

Itovebi-based regimen reduces disease worsening or death risk by 57% in HR-positive, HER2-negative breast cancer with PIK3CA mutation, per INAVO120 study. FDA approved Itovebi as first-line treatment, with data published in the New England Journal of Medicine.

Itovebi-based regimen significantly reduces disease worsening or death risk by 57% in HR-positive, HER2-negative breast cancer with PIK3CA mutation, per INAVO120 study. FDA approved Itovebi in combination with palbociclib and fulvestrant for first-line treatment, with data submitted to other global health authorities.

Genentech's Itovebi shows 57% reduction in disease progression or death risk, extending progression-free survival from 7.3 to 15.0 months in HR-positive, HER2-negative breast cancer, published in the New England Journal of Medicine. FDA approved Itovebi for PIK3CA-mutated cases.

A study led by Prof. Nick Turner at the Institute of Cancer Research demonstrates the potential of a three-drug therapy (inavolisib, palbociclib, and fulvestrant) to significantly improve progression-free survival in HR-positive breast cancer with PIK3CA mutations. The combination, already approved by the US FDA, could represent a transformative advance for patients.

October 2024 saw 4 new FDA cancer drug approvals: asciminib for CML, zolbetuximab-clzb for CLDN18.2-positive gastric/GEJ adenocarcinoma, inavolisib plus palbociclib/fulvestrant for PIK3CA-mutant HR+/HER2- breast cancer, and neoadjuvant/adjuvant nivolumab for NSCLC without EGFR/ALK mutations.

ddPCR detected PIK3CA (H1047R) mutations in 32.5% of CMT FFPE samples, higher than previous Sanger sequencing results. The method's sensitivity and specificity are beneficial for FFPE samples. PIK3CA mutations were more frequent in benign and grade I CMTs, suggesting an early oncogenic role. Histological subtypes and liquid biopsy concordance rates were also analyzed, highlighting the potential of liquid biopsy for early detection and treatment monitoring in canine patients.

Roche reports 6% Group sales growth at constant exchange rates, driven by high demand for medicines and diagnostics. Pharmaceuticals Division sales rose 7%, with strong growth in base business, led by Vabysmo, Phesgo, and Ocrevus. Diagnostics Division sales increased 5%, with base business growing 8%. Key developments include US and EU approvals for new treatments, positive phase III data, and acquisitions to strengthen pipelines. Outlook for 2024 is confirmed.

Study protocol approved by Amsterdam UMC IRB (2021-0511) for retrospective analysis of 530 HPV-negative HNSCC samples from TCGA, with data from cBioPortal and GDC portal. MLPA probe mix P477 developed for 10 DNA regions in HPV-negative HNSCC. FFPE tumor core biopsies underwent lcWGS and target-enrichment sequencing. Statistical analysis using GraphPad Prism 9.3.1 and R 4.2.3, with survival analysis by survival and survminer packages.

Dr. Ursa Brown-Glaberman discusses therapeutic options for breast cancer patients with PIK3CA mutations, recommending fulvestrant plus alpelisib or capivasertib. Capivasertib, a newer PIK3CA inhibitor, showed improved progression-free survival in the CAPItello-291 trial. Hyperglycemia is less severe with capivasertib compared to alpelisib, making it easier to use, especially in prediabetic or diabetic patients.