Itovebi (inavolisib)

P2, N=160, Not yet recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

P1, N=30, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Sep 2028 --> Jul 2027 | Trial primary completion date: Sep 2028 --> Jul 2027

This analysis demonstrates the generally consistent, manageable and tolerable safety profile of inavolisib plus palbociclib-fulvestrant. Key selected adverse events were generally reversible and were controlled by concomitant medications and dose modifications.

Normal baseline glycemic indices do not reliably exclude the risk of severe toxicity. Early metabolic assessment, close glucose monitoring, prompt interruption of inavolisib when clinically indicated, and rapid insulin-based management are essential for timely recognition and safe clinical care.

P1, N=30, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting

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.