Roche’s Itovebi Demonstrates Significant Overall Survival Benefit in Advanced Breast Cancer Study
Roche announced positive topline results from the overall survival (OS) analysis of the phase III INAVO120 study investigating Itovebi (inavolisib) in combination with palbociclib and fulvestrant13.
The study focused on patients with PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, endocrine-resistant, locally advanced or metastatic breast cancer13.
The Itovebi-based regimen showed a statistically significant and clinically meaningful OS benefit compared to palbociclib and fulvestrant alone13.
Previously reported primary analysis demonstrated that the Itovebi-based regimen reduced the risk of disease worsening or death by 57% compared to the control group (15.0 months vs. 7.3 months; hazard ratio [HR]=0.43)12.
The INAVO120 study included 325 patients randomized to either the investigational or control treatment arm2.
Full results from the OS analysis will be presented at an upcoming medical meeting13.
Roche's Chief Medical Officer, Levi Garraway, stated that the Itovebi-based regimen has the potential to become the new standard of care for these patients13.
The U.S. FDA recently approved Itovebi in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer2.
Detailed results from the INAVO120 study were published in the New England Journal of Medicine2.
Roche is aiming for Itovebi to achieve peak sales of $2 billion, with additional pivotal studies ongoing in other settings6.
Sources:
1. https://www.medthority.com/news/2025/1/positive-topline-results-from-phase-iii-inavo120-study-investigating-itovebi-inavolisib--palbociclib-ibrance--fulvestrant--for-pik3ca-mutated-hr-her2---endocrine-resistant-breast-cancer--roche/
2. https://www.roche.com/media/releases/med-cor-2024-10-31
3. https://www.pharmabiz.com/NewsDetails.aspx?aid=174964&sid=2
6. https://www.oncologypipeline.com/apexonco/roche-claims-itovebi-breast-cancer-survival-benefit