TL/DR –
New data reveals that Genentech’s Itovebi has significantly extended survival in HR-positive advanced breast cancer. It reduced the risk of death by over 30% in individuals with PIK3CA-mutated HR-positive, HER2-negative advanced breast cancer, compared to those treated with palbociclib and fulvestrant alone. The data from the Phase III INAVO120 study was presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the New England Journal of Medicine.
Significant Improvement in Survival Rates with Itovebi for HR-Positive Advanced Breast Cancer
Data presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting reveals the remarkable efficacy of Itovebi (inavolisib), a PIK3CA pathway-targeted drug, in extending survival rates in HR-positive, HER2-negative advanced breast cancer patients. This significant data is also published in the New England Journal of Medicine.
Positive Results from Phase III INAVO120 Study
Final results of the Phase III INAVO120 study show that Itovebi, in combination with palbociclib and fulvestrant, reduced death risks by more than 30% compared with palbociclib and fulvestrant alone. This presents a meaningful improvement in overall survival for patients with PIK3CA-mutated, endocrine-resistant, locally advanced or metastatic breast cancer. This landmark data for the Itovebi regimen also prolonged patients’ time without chemotherapy.
Benefits of Itovebi-Based Regimen
The Itovebi regimen demonstrated a meaningful overall survival benefit compared with palbociclib and fulvestrant alone. The median overall survival was 34.0 months compared with 27.0 months. The Itovebi regimen also showed a significant improvement in objective response rate and delayed time to chemotherapy by nearly two years. With a low discontinuation rate due to adverse events, it indicated good tolerability.
Ongoing Studies on Itovebi
Itovebi is currently under investigation in three Phase III studies (INAVO121, INAVO122, INAVO123), all in PIK3CA-mutated, locally advanced or metastatic breast cancer in various combinations. The aim is to provide more patients with PIK3CA mutations the benefits of this targeted therapy.
For more details on the INAVO120 study, visit clinicaltrials.gov.
About HR-Positive Breast Cancer
HR-positive breast cancer accounts for approximately 70% of all breast cancer cases. Patients diagnosed with this type of breast cancer often face the risk of disease progression and treatment side effects. The PI3K signaling pathway, often dysregulated in HR-positive breast cancer due to activating PIK3CA mutations, is identified as a potential mechanism of resistance to standard care therapy.
About Itovebi
Itovebi (inavolisib) is a prescription medicine used in combination with palbociclib and fulvestrant to treat adults with HR-positive, HER2-negative breast cancer with abnormal PIK3CA genes. It’s used for treating locally advanced or metastatic breast cancer that has come back after hormone therapy. For safety information, review the full Itovebi Prescribing Information or visit https://www.itovebi.com.
About Genentech
Genentech, a member of the Roche Group, has been advancing breast cancer research for over 30 years with the aim of helping as many patients as possible. Their medicines have contributed to breakthrough outcomes in different subtypes of breast cancer. For more information, visit http://www.gene.com.
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