Inavolisib plus palbociclib–fulvestrant significantly improved overall survival in PIK3CA-mutated, hormone receptor–positive, HER2-negative advanced breast cancer.
The median overall survival increased by 7 months compared to placebo, with a hazard ratio for death of 0.67.
Substantial increases in objective response rate and progression-free survival were observed.
Adverse events such as hyperglycemia, stomatitis, gastrointestinal, and ocular effects were more frequent with inavolisib.