SHERIDAN, WYOMING – June 1, 2025 – Roche has announced compelling final overall survival data from its phase III INAVO120 study, showing that the Itovebi™ (inavolisib)-based regimen reduces the risk of death by more than 30% in patients with PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer. The findings were presented at the 2025 ASCO Annual Meeting and simultaneously published in the New England Journal of Medicine.
First PI3K Inhibitor to Prolong Survival in This Breast Cancer Subtype
The INAVO120 trial demonstrated that Itovebi, when combined with palbociclib and fulvestrant, achieved a median overall survival (OS) of 34.0 months compared to 27.0 months for the control group receiving palbociclib and fulvestrant alone. This represents a statistically significant and clinically meaningful improvement (HR=0.67; p=0.0190).
“For the first time, a PI3K pathway-targeted drug has shown it can help people with this breast cancer subtype live longer,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Itovebi exemplifies our continued commitment to improve survival rates for people with this common PIK3CA mutation, for whom more effective treatment options are needed.”
Extending Life and Time Without Chemotherapy
The Itovebi-based regimen also doubled median progression-free survival (PFS) to 17.2 months, compared with 7.3 months for the control arm (HR=0.42), and showed a marked improvement in objective response rate. Notably, Itovebi delayed time to chemotherapy by approximately two years.
“The landmark data for the inavolisib-based regimen showed not only a doubling in progression-free survival, but importantly that it extended lives and gave people more time without chemotherapy,” said Professor Nicholas Turner, Lead Study Author and Professor of Molecular Oncology at The Institute of Cancer Research, and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, London, United Kingdom. “These results give us confidence that this regimen could become the new standard of care in the first-line setting, having demonstrated a substantial benefit on patient outcomes and quality of life.”
Positive Global Regulatory Momentum
Itovebi has been approved in the United States, Switzerland, Canada, Australia, United Arab Emirates, and China. It also received a positive opinion from the European Medicines Agency’s CHMP in May, with a final decision from the European Commission expected shortly.
Ongoing Research to Broaden Clinical Impact
Beyond INAVO120, Roche is advancing three additional phase III trials—INAVO121, INAVO122, and INAVO123—exploring Itovebi in various combinations for other breast cancer subtypes:
- INAVO121: inavolisib plus fulvestrant versus alpelisib plus fulvestrant in HR-positive/HER2-negative breast cancer post-CDK4/6 inhibitor therapy.
- INAVO122: inavolisib with pertuzumab and trastuzumab SC versus placebo in HER2-positive disease.
- INAVO123: inavolisib with CDK4/6 inhibitor and letrozole versus placebo in endocrine-sensitive HR-positive/HER2-negative breast cancer.
Differentiated Mechanism and Clinical Relevance
Itovebi is an oral PI3K alpha-selective inhibitor that promotes degradation of mutated PI3K alpha, with a design aimed at minimizing treatment burden and toxicity. It addresses a major resistance mechanism in HR-positive advanced breast cancer, where PIK3CA mutations affect approximately 40% of cases and are linked to poor outcomes.
Roche’s Enduring Leadership in Breast Cancer
Roche has led oncology research for over 30 years. Its integrated approach—spanning pharmaceuticals, diagnostics, and real-world data—continues to shape personalized treatment strategies. In HR-positive breast cancer, the most prevalent form of the disease, the company remains focused on delivering innovative, biomarker-driven therapies for patients with limited options.
Learn more at www.roche.com