Roche announced the publication of detailed analysis of the positive phase III INAVO120 results in the New England Journal of Medicine, evaluating Itovebi in combination with palbociclib and fulvestrant. The FDA recently approved Itovebi in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer. The study included 325 patients and showed the Itovebi-based regimen reduced the risk of disease worsening or death by 57% compared to palbociclib and fulvestrant alone. Overall survival data were immature at the time of analysis, but a clear positive trend has been observed. Itovebi is currently being investigated in three company-sponsored phase III clinical studies in PIK3CA-mutated locally advanced or metastatic breast cancer in various combinations. The PIK3CA mutation is found in approximately 40% of HR-positive metastatic breast cancers and is associated with a poor prognosis. Historically, the use of PI3K targeted therapy in the first-line advanced setting has been limited and therefore testing for PIK3CA mutations is not common at the time of diagnosis. Early biomarker testing with an FDA-approved test, such as Foundation Medicine’s FoundationOne Liquid CDx, before first-line treatment is crucial to help identify people who may benefit from targeted therapy, such as Itovebi.