Roche’s oral PI3K inhibitor Itovebi (inavolisib) has been approved by the European Commission (EC) as part of a combination treatment for advanced breast cancer patients.
The drug has been authorised for use alongside Pfizer’s CDK4/6 inhibitor Ibrance (palbociclib) and AstraZeneca’s hormone therapy Faslodex (fulvestrant) in adults with PIK3CA-mutated, oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer.
Patients will be eligible for the combination following recurrence on or within 12 months of completing adjuvant endocrine treatment.
The EC’s decision was supported by results from the late-stage INAVO120 trial, in which the Itovebi-based regimen reduced the risk of disease worsening or death by 57% compared with Ibrance and Faslodex alone in the first-line setting, with this benefit consistent across all pre-specified subgroups.
The triplet therapy also reduced the risk of death by 33% and delayed the time to chemotherapy by approximately two years compared with Ibrance and Faslodex alone.
ER-positive breast cancer is a subtype of hormone receptor-positive breast cancer, which accounts for approximately 70% of all breast cancer cases.
The PI3K signalling pathway is often dysregulated in HR-positive breast cancer, often due to activating PIK3CA mutations, which are considered to be a potential mechanism of resistance to standard-of-care hormone therapy in combination with CDK4/6 inhibitors.
Roche’s chief medical officer and head of global product development, Levi Garraway, said: “Itovebi is the first treatment of its kind to improve survival outcomes for those living with PIK3CA-mutated, ER-positive advanced breast cancer.
“Therefore, the Itovebi-based regimen may help address an important unmet need for people with this subtype of breast cancer.”
Itovebi is also currently being evaluated in various combinations across three additional late-stage studies in PIK3CA-mutated, locally advanced or metastatic breast cancer.
Breast cancer is a key focus area for Roche, with the Itovebi approval coming just two months after the company shared positive results from a late-stage study of its Perjeta (pertuzumab)-based regimen in patients with operable HER2-positive early-stage breast cancer.