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

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

P1/2, N=8, Active, not recruiting, City of Hope Medical Center | Trial completion date: Feb 2026 --> Feb 2027 | Trial primary completion date: Feb 2026 --> Feb 2027

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.

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.

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.

P1, N=63, Not yet recruiting, Regor Pharmaceuticals Inc.

Background: Alpelisib plus fulvestrant improves outcomes in PIK3CA-mutated, hormone receptor-positive, HER2-negative metastatic breast cancer. Evening alpelisib preceded by fasting and low-carbohydrate guidance may improve metabolic tolerability without compromising efficacy or QoL. These findings support evaluation in a larger trial incorporating prospective metabolic adherence and pharmacokinetic assessments.

A panel of EC cell lines, including patient-derived models with varying PIK3CA mutation status and platinum sensitivity, was treated with camonsertib (ATR inhibitor) and inavolisib (PI3Kα inhibitor). Our findings establish dual ATR and PI3Kα inhibition as a genotype-informed therapeutic strategy for platinum-resistant EC. PIK3CA mutation status may influence the mode of cell death, supporting its use as a predictive biomarker for patient stratification in future clinical applications.

This study reports ANXA3 as a biomarker o predict poor prognosis and lenvatinib resistance in HCC. The combined use of Alpelisib and lenvatinib may serve as a potential therapeutic strategy for lenvatinib-resistant HCC.

P2, N=48, Not yet recruiting, National Cancer Institute, Naples

Alpelisib plus fulvestrant provides clinical benefit for patients with PIK3CA-altered, HR+, HER2- ABC across a range of concomitant alterations, including those previously implicated in endocrine therapy or CDK4/6i resistance. Machine learning models identified factors including gene mutations that influenced PFS.