Swiss drugmaker Roche announced that the European Commission (EC) has approved Itovebi (inavolisib) in combination with palbociclib and fulvestrant to treat advanced breast cancer with a PIK3CA mutation.
The combination is indicated for adults with PIK3CA-mutated, oestrogen receptor-positive, HER2-negative, locally advanced or metastatic breast cancer, especially those experiencing recurrence within 12 months of prior treatment.
The approval is based on the Phase 3 INAVO120 trial, a randomised, double-blind, placebo-controlled study evaluating the efficacy and safety of the Itovebi combination.
In the study, Itovebi-based regimen showed a significant 57% reduction in the risk of disease progression or death, compared to palbociclib and fulvestrant alone.
The progression-free survival benefit was consistent across all pre-specified subgroups, and the regimen was well tolerated with no new safety concerns.
Further analysis from INAVO120 indicated that the Itovebi-based treatment reduced the risk of death by 33% and delayed the need for chemotherapy by approximately two years.
The study findings highlight the potential of Itovebi to improve patient outcomes significantly.
Roche chief medical officer and global product development head Levi Garraway said: “Itovebi is the first treatment of its kind to improve survival outcomes for those living with PIK3CA-mutated, ER-positive advanced breast cancer.
“Therefore, the Itovebi-based regimen may help address an important unmet need for people with this subtype of breast cancer.”
Roche is conducting additional Phase 3 studies to explore Itovebi’s efficacy in various combinations for PIK3CA-mutated, locally advanced or metastatic breast cancer.
The Swiss pharmaceutical company is also exploring its use in other tumour types to extend the benefits of this targeted therapy.
Apart from the EC approval, the Itovebi-based regimen has received approval in Australia, Canada, China, Switzerland, Taiwan, the UAE, and the US for the same indication.
