Roche announces positive Phase III results for inavolisib combination in people with advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation

Phase III (INAVO120) results show that inavolisib in combination with palbociclib and fulvestrant significantly improved progression-free survival in the first-line settingPIK3CA mutations, found in approximately 40% of HR-positive breast cancers, are linked to tumour growth, disease progression, and treatment resistance1,2Data will be shared with health authorities and presented at an upcoming medical meetingBasel, 5 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive results from the Phase III INAVO120 study of the investigational therapy, inavolisib, in combination with palbociclib (Ibrance ®) and fulvestrant as a potential first-line treatment option for people withPIK3CA-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 at this time, but a clear positive trend has been observed. Follow-up will continue to the next analysis." These pivotal study results for this inavolisib combination could represent a transformative medical advance for people withPIK3CA-mutated HR-positive breast cancer, " said Levi Garraway, M.D., Ph.D., Roche ’s Chief Medical Officer and Head of Global Product Development. " We look forward to expanding our portfolio of brea...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news