SHERIDAN, WYOMING – July 25, 2025 – Roche has received European Commission (EC) approval for Itovebi™ (inavolisib), a targeted therapy for adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer. The approval marks a significant milestone in the treatment of a subtype associated with poor prognosis and limited therapeutic options.
Regulatory milestone based on robust clinical evidence
The EC’s decision was driven by data from the pivotal phase III INAVO120 study, published in The New England Journal of Medicine in October 2024. The trial demonstrated that the Itovebi-based regimen—when used in combination with palbociclib (Ibrance®) and fulvestrant—more than doubled progression-free survival (15.0 months vs. 7.3 months; HR=0.43; p<0.001) compared with palbociclib and fulvestrant alone.
The treatment also reduced the risk of death by 33% (HR=0.67; p=0.0190) and delayed the need for chemotherapy by approximately two years. These results were reaffirmed in the final overall survival analysis presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
Targeted innovation meets urgent clinical need
“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, MD, PhD, 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.”
Up to 40% of ER-positive breast cancers harbor PIK3CA mutations, which have been linked to resistance to standard endocrine therapies. Itovebi addresses this resistance with a differentiated mechanism of action: high selectivity for the PI3K alpha isoform and the ability to degrade mutated PI3K alpha, thereby minimizing treatment burden and toxicity.
Strategic portfolio expansion and pipeline momentum
The EC approval follows similar regulatory decisions in the United States, Switzerland, Canada, Australia, the United Arab Emirates, China, and Taiwan. Meanwhile, the INAVO120 data remain under review by other global health authorities.
Beyond INAVO120, Roche is actively expanding its clinical program with three additional phase III trials:
- INAVO121: Comparing Itovebi plus fulvestrant to alpelisib plus fulvestrant in HR-positive/HER2-negative breast cancer post-CDK4/6 inhibitor therapy.
- INAVO122: Investigating Itovebi with pertuzumab and trastuzumab (SC) in HER2-positive disease.
- INAVO123: Evaluating Itovebi plus a CDK4/6 inhibitor and letrozole in first-line treatment of endocrine-sensitive breast cancer.
These studies aim to extend Itovebi’s clinical utility across broader patient populations and combination strategies.
Strengthening Roche’s leadership in breast cancer
With over three decades of breast cancer innovation, Roche continues to lead with targeted therapies and companion diagnostics. The company’s expanding portfolio reflects its strategic commitment to precision oncology, including ER-positive breast cancer—the most prevalent form, accounting for approximately 70% of all cases.
By addressing the molecular mechanisms behind treatment resistance, Roche is setting a new benchmark in the personalized treatment of breast cancer.
Learn more at www.roche.com