SOUTH SAN FRANCISCO (dpa-AFX) - Genentech, a member of the Roche Group (RHHBY), Tuesday reported positive top line data from overall survival (OS) analysis of the Phase 3 INAVO120 study investigating Itovebi in combination with Ibrance and Fulvestrant for people with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, endocrine-resistant breast cancer.
Primary analysis showed the Itovebi-based regimen reached statistical significance, more than doubling progression-free survival in this patient population.
Previously, data from the primary analysis showed that Itovebi-based regimen reduced the risk of disease worsening or death by 57 percent compared with palbociclib and fulvestrant alone.
The U.S. Food and Drug Administration (FDA) approved the Itovebi-based regimen in October last year for the treatment of adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer.
The company noted that these OS results builds upon the previously reported primary analysis, which showed that the Itovebi-based regimen reduced the risk of disease worsening or death by 57% compared with palbociclib and fulvestrant alone
Itovebi is currently being investigated in four Phase 3 studies including INAVO120, INAVO121, INAVO122, and INAVO123 in PIK3CA-mutated locally advanced or metastatic breast cancer in various combinations.
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