Landmark Phase III results for Roche’s Itovebi

Swiss pharma giant Roche (ROG: SIX) has released detailed analysis of the positive Phase III INAVO120 results, evaluating Itovebi (inavolisib) in combination with palbociclib (Ibrance) and fulvestrant were published in the New England Journal of Medicine.

Results showed the Itovebi-based regimen reduced the risk of disease worsening or death (progression-free survival [PFS]) by 57% compared to palbociclib and fulvestrant alone (15.0 months versus 7.3 months; hazard ratio [HR]=0.43, 95% CI: 0.32-0.59, p<0.001). PFS benefit was consistent across all pre-specified subgroups, including people whose disease had spread to three or more locations, which is characterized as difficult-to-treat disease. Overall survival (OS) data were immature at the time of analysis, but a clear positive trend has been observed (stratified HR=0.64, 95% CI: 0.43-0.97, p=0.03 [boundary of 0.0098]). Follow-up for OS will continue to the next analysis.

Roche noted that the US Food and Drug Administration (FDA) earlier this month 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.