Roche announces phase III INAVO120 results were published

Roche (RHHBY) announced that a detailed analysis of the positive phase III INAVO120 results, evaluating Itovebi in combination with palbociclib and fulvestrant were published in the New England Journal of Medicine.1 The United States Food and Drug Administration, 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, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. Data from INAVO120 are also being used for filing submissions to other global health authorities, including the European Medicines Agency. Results showed the Itovebi-based regimen reduced the risk of disease worsening or death by 57% compared to palbociclib and fulvestrant alone. PFS benefit was consistent across all pre-specified subgroups, including people whose disease had spread to three or more locations, which is characterised as difficult-to-treat disease.1 Overall survival data were immature at the time of analysis, but a clear positive trend has been observed. Follow-up for OS will continue to the next analysis.