EC approves Roche’s Itovebi for breast cancer subtype
The European Commission has approved Itovebi (inavolisib), in combination with palbociclib (Ibrance) and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer.
It is approved following recurrence on or within 12 months of completing adjuvant endocrine treatment.
“Itovebi is the first treatment of its kind to improve survival outcomes for those living with PIK3CA-mutated, ER-positive advanced breast cancer,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “Therefore, the Itovebi-based regimen may help address an important unmet need for people with this subtype of breast cancer.”
The approval is based on results from the Phase III INAVO120 trial, which showed a 57% reduction in the risk of disease worsening or death (progression-free survival, PFS) with the Itovebi-based regimen compared with palbociclib and fulvestrant alone (15.0 months vs. 7.3 months) in the first-line setting.
The PFS benefit was consistent across all pre-specified subgroups and the Itovebi-based regimen was well tolerated, with no new safety signals observed.
These results were reinforced by the INAVO120 final overall survival analysis that showed the Itovebi-based regimen reduced the risk of death by 33%.
Additionally, the treatment regimen substantially delayed the time to chemotherapy by approximately two years compared with palbociclib and fulvestrant alone.
Beyond INAVO120, Itovebi is currently being investigated in three company-sponsored Phase III studies (INAVO121, INAVO122, INAVO123), all in PIK3CA-mutated, locally advanced or metastatic breast cancer in various combinations.
The Itovebi-based regimen is also approved for the treatment of adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer in the US, Switzerland, Canada, Australia, United Arab Emirates, China and Taiwan, with data from INAVO120 under review with several other global health authorities.
Diana Turner, Senior Digital Content Editor, DDW