Itovebi (inavolisib)

P3, N=420, Active, not recruiting, Hoffmann-La Roche | Trial primary completion date: Apr 2026 --> Nov 2026

P2, N=100, Recruiting, Hoffmann-La Roche

P1/2, N=792, Recruiting, Hoffmann-La Roche | N=56 --> 792

PI3Kα inhibitors, particularly alpelisib and inavolisib, combined with endocrine therapy improved progression-free survival in PIK3CA-mutated HR+/HER2- advanced breast cancer, while alpelisib was the only agent to demonstrate an overall survival benefit. PI3Kα inhibitors show promising efficacy in PIK3CA-mutated HR+/HER2- breast cancer, but publication bias, resistance, target-specific toxicity, and geographic disparities remain major barriers. Mandatory trial reporting, biomarker-guided treatment, and international collaboration should be prioritized.

Although two orthosteric PI3Kα inhibitors including Alpelisib and Inavolisib have been launched onto market, they often cause toxic and side effects due to insufficient selectivity for PIK3CA mutant protein...Our research focuses on optimizing a novel series of allosteric PI3Kα inhibitors derived from STX-478...The inhibitor demonstrates high selectivity for PIK3CA mutant protein, low hERG inhibition, minimal CYP inhibition, excellent in vivo efficacy, good safety and no impact on insulin balance. Collectively, these findings confirm that compound 11f is a highly promising drug candidate for the targeted therapy of PIK3CA H1047R mutant HR+/HER2-breast cancer.

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

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.

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.

P3, N=100, Recruiting, Hoffmann-La Roche | N=23 --> 100

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