PIK3CA and breast carcinoma: In the Phase III INAVO120 study, addition of inavolisib to palbociclib and fulvestrant significantly extended median progression-free survival to 15.0 months versus 7.3 months in the control arm (hazard ratio 0.43) and increased objective response rate (ORR) to 58.4% compared with ~25% in the control arm, demonstrating meaningful clinical benefit in PIK3CA-mutated HR+/HER2- advanced breast cancer (28, 29).