CHMP recommends EU approval of Roche’s Itovebi for PIK3CA-mutated, ER-positive, HER2-negative, advanced breast cancer

Core Viewpoint - Roche's Itovebi™ (inavolisib) has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for use in combination with palbociclib and fulvestrant for treating specific breast cancer patients, potentially transforming first-line treatment standards [1][2][3]. Group 1: Treatment Efficacy - The CHMP's positive opinion is based on phase III INAVO120 study results, which demonstrated a 57% reduction in the risk of disease worsening or death (progression-free survival) with the Itovebi-based regimen compared to palbociclib and fulvestrant alone (15.0 months vs. 7.3 months; hazard ratio [HR]=0.43, p<0.001) [3][8]. - The final overall survival analysis showed a statistically significant benefit with the Itovebi-based regimen, with a stratified HR of 0.64 (95% CI: 0.43-0.97, p=0.0338) [4][8]. Group 2: Patient Population and Mutation Significance - The presence of a PIK3CA mutation, found in approximately 40% of hormone receptor-positive breast cancers, is associated with more aggressive disease and poorer survival outcomes, highlighting the need for testing prior to treatment [2][3]. - The Itovebi-based regimen is specifically designed for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative breast cancer [5][7]. Group 3: Ongoing Research and Development - Beyond the INAVO120 study, Itovebi is being investigated in three additional phase III studies (INAVO121, INAVO122, INAVO123) for various combinations in PIK3CA-mutated breast cancer [6][11]. - Roche aims to explore additional studies in breast cancer and other tumor types to expand the benefits of this targeted therapy [6][11].