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Roche Holdings AG (OTC: RHHBY) announced results from the Phase 3 INAVO120 study of the investigational therapy, inavolisib, in combination with palbociclib (Ibrance) and fulvestrant as a potential first-line treatment option for people with PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, endocrine-resistant, locally advanced or metastatic breast cancer.
The study met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant and clinically meaningful improvement compared to palbociclib and fulvestrant alone.
Overall survival data were immature, but a clear positive trend has been observed. Follow-up will continue to the next analysis.
PIK3CA mutations, found in approximately 40% of HR-positive breast cancers, are linked to tumor growth, disease progression, and treatment resistance.
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"These pivotal study results for this inavolisib combination could represent a transformative medical advance for people with PIK3CA-mutated HR-positive breast cancer," said Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development.
The inavolisib combination was well tolerated, and adverse events were consistent with the known safety profiles of the individual study treatments, with no new safety signals observed.
Inavolisib is currently being investigated in three Phase 3 studies in people with PIK3CA-mutated metastatic breast cancer (INAVO120, INAVO121, INAVO122) in various combinations.
