Roche (RHHBY) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Itovebi (inavolisib). The recommendation covers use in adults with PIK3CA-mutated, ER-positive, HER2-negative, locally advanced or metastatic breast cancer that relapsed within 12 months of completing adjuvant endocrine therapy. A final decision from the European Commission is expected soon.
Combination with Ibrance and Faslodex
Roche seeks approval for Itovebi in combination with:
Pfizer’s Ibrance (palbociclib)
AstraZeneca’s Faslodex (fulvestrant)
Both Ibrance and Faslodex are already approved for treating ER-positive breast cancer. Roche noted that this Itovebi-based regimen is approved in the United States and several other regions. Additional regulatory reviews are underway globally.
Strong Phase III INAVO120 Results
The CHMP opinion was based on the Phase III INAVO120 study. Key findings include:
A 57% reduction in the risk of disease progression or death compared with Ibrance plus Faslodex alone.
Consistent benefit across all patient subgroups, including those with more aggressive, multi-site disease.
A well-tolerated safety profile with no new concerns identified.
In January 2025, Roche reported a final overall survival (OS) analysis from INAVO120. It confirmed a statistically significant and clinically meaningful survival improvement with the Itovebi regimen. Full OS data will be presented at the 2025 American Society of Clinical Oncology Annual Meeting.
Market Impact and Future Plans
Roche’s stock (RHHBY) has risen 13.7% year-to-date, outperforming the industry average, which has fallen 5.7%.
PIK3CA mutations occur in about 40% of hormone receptor-positive breast cancer patients. They are linked to more aggressive disease and poorer outcomes. Roche emphasized the need for early PIK3CA mutation testing to guide first-line treatment decisions and deliver targeted therapies promptly.
Beyond INAVO120, Roche is running three additional late-stage trials of Itovebi in various combinations for PIK3CA-mutant breast cancer. The company also plans further studies in other tumor types to expand the reach of this targeted therapy.
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