Roche announced that the European Commission has approved Itovebi™ (inavolisib) for use in combination with palbociclib (Ibrance®) and fulvestrant to treat adult patients with PIK3CA-mutated, estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer. The approval applies to patients whose disease has recurred during or within 12 months of completing adjuvant endocrine therapy.
“Itovebi is the first therapy to show improved survival outcomes for patients with this specific subtype of advanced breast cancer,” said Dr. Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche. “This regimen addresses a significant unmet need in breast cancer care.”
The approval is supported by data from the Phase III INAVO120 trial, published in the New England Journal of Medicine (October 2024), which demonstrated a 57% reduction in the risk of disease progression or death when Itovebi was added to palbociclib and fulvestrant compared to the standard regimen alone (PFS: 15.0 vs. 7.3 months; HR=0.43, p<0.001). The progression-free survival benefit was consistent across all subgroups and the combination was well tolerated, with no new safety concerns observed.
Further results from the final overall survival analysis in INAVO120 showed that the Itovebi-based combination reduced the risk of death by 33% (HR=0.67; p=0.0190). Additionally, it delayed the need for chemotherapy by nearly two years, a major quality-of-life advantage for patients.
These pivotal findings were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in NEJM in May 2025.
Beyond INAVO120, Itovebi is being evaluated in three additional Phase III trials (INAVO121, INAVO122, INAVO123) across various treatment combinations in PIK3CA-mutated advanced breast cancer. Roche is also exploring its potential in other cancers with PIK3CA mutations, aiming to expand the reach of this targeted therapy.