SHERIDAN, WYOMING – May 27, 2025 – Roche has received a significant endorsement from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), which issued a positive opinion for Itovebi™ (inavolisib) in combination with palbociclib and fulvestrant. This recommendation positions Roche to offer a first-line treatment solution for adult patients with PIK3CA-mutated, ER-positive, HER2-negative, locally advanced or metastatic breast cancer—an area with limited current treatment options.
This development is underpinned by data from the phase III INAVO120 study, which demonstrated that the Itovebi-based regimen more than doubled progression-free survival compared to the standard treatment alone. The recommendation marks a key milestone toward potential European Commission approval, with broader implications for treatment standards across the region.
Strategic Data Validates Therapeutic Potential
The CHMP’s decision follows compelling results from the INAVO120 study, published in the New England Journal of Medicine, which showed a 57% reduction in disease progression or death when using Itovebi alongside palbociclib and fulvestrant (15.0 months vs. 7.3 months; HR=0.43, 95% CI: 0.32–0.59, p<0.001). This benefit was seen across all subgroups, including those with aggressive disease characterized by metastasis in three or more locations.
Positive final overall survival (OS) data, to be presented at the 2025 ASCO Annual Meeting, further supports the CHMP recommendation. In January 2025, Roche disclosed a statistically significant and clinically meaningful OS benefit (stratified HR=0.64, 95% CI: 0.43–0.97, p=0.0338), despite the immature data in the primary analysis.
Expert Endorsement and Clinical Relevance
Dr. Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development, emphasized the clinical significance, stating:
“The positive CHMP recommendation for the Itovebi-based regimen represents a significant step towards providing people in the EU with PIK3CA-mutated, ER-positive advanced breast cancer with a targeted therapy in the first-line setting. This recommendation is further enforced by the recent final overall survival results from the INAVO120 study, showing the regimen can meaningfully extend survival.”
With PIK3CA mutations present in approximately 40% of hormone receptor-positive breast cancers, early identification through molecular diagnostics is critical. Roche’s Itovebi offers a potent, PI3K-targeted therapeutic pathway to address this subgroup’s urgent clinical needs.
Global Expansion and Ongoing Clinical Development
The Itovebi-based regimen has already secured approval in the U.S., Switzerland, Canada, Australia, UAE, and China. Regulatory review is ongoing in several other markets. Simultaneously, Roche continues to invest in global clinical development with three additional phase III trials:
- INAVO121: Itovebi + fulvestrant vs. alpelisib + fulvestrant post-CDK4/6 inhibitor (NCT05646862)
- INAVO122: Itovebi + pertuzumab/trastuzumab (Phesgo) vs. placebo in HER2-positive patients (NCT05894239)
- INAVO123: Itovebi + CDK4/6 inhibitor + letrozole vs. placebo combo in endocrine-sensitive HR-positive, HER2-negative cases (NCT06790693)
Targeted Design and Differentiated Profile
Itovebi’s mechanism targets PI3K alpha isoforms with precision, enabling degradation of the mutated PI3K alpha protein. Its specificity and tolerability profile distinguish it from earlier PI3K inhibitors, supporting sustained disease control with minimized toxicity.
Broader Oncology Vision from Roche
Roche has been a pioneer in breast cancer research for over three decades, advancing innovations for HER2-positive and triple-negative breast cancers. With Itovebi, the company extends its leadership into hormone receptor-positive disease, aligning with a broader vision of biomarker-driven and personalized treatment strategies.
Industry Outlook
Roche’s latest development in targeted breast cancer therapy aligns with a broader industry trend: integrating genomic insights into clinical decision-making to improve outcomes in hard-to-treat cancers. As the regulatory landscape evolves and biomarker testing becomes routine, Itovebi could play a central role in redefining first-line treatment paradigms.
To explore Roche’s breast cancer pipeline and the company’s broader oncology portfolio, visit www.roche.com.