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][7] - The final overall survival analysis indicated a statistically significant and clinically meaningful benefit with the Itovebi-based regimen, with a stratified HR of 0.64 (p=0.0338) [3][7] 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 targeted therapies [2][9] - The Itovebi-based regimen is specifically designed for adult patients with PIK3CA-mutated, ER-positive, HER2-negative, locally advanced or metastatic breast cancer who have experienced recurrence [1][4] Group 3: Regulatory Status and Future Studies - Itovebi is already approved in several countries, including the United States and China, for treating endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative breast cancer [4] - Roche is conducting three additional phase III studies (INAVO121, INAVO122, INAVO123) to explore further applications of Itovebi in various combinations for breast cancer treatment [5][8]
CHMP recommends EU approval of Roche's Itovebi for PIK3CA-mutated, ER-positive, HER2-negative, advanced breast cancer