Roche received FDA Breakthrough Designation for Inavolisib in HR-Positive, HER2-Negative Breast Cancer
Roche has received Breakthrough Therapy Designation from the U.S. FDA for inavolisib, an investigational oral therapy, combined with palbociclib (Ibrance®) and fulvestrant.
This designation is aimed at treating adult patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer, particularly those who have had a recurrence within 12 months of completing adjuvant endocrine therapy.
The Breakthrough Therapy Designation accelerates the development and review process for treatments that show significant improvement over existing therapies based on early clinical evidence.
The designation follows results from the Phase III INAVO120 trial, which demonstrated that the inavolisib regimen reduced the risk of disease progression or death by 57% compared to the control group using palbociclib and fulvestrant alone.
Progression-free survival was 15.0 months for the inavolisib group versus 7.3 months for the control (HR = 0.43, p < 0.0001). While overall survival data are still pending, early results are promising.
PIK3CA mutations are common in advanced or metastatic breast cancer, but testing is often delayed. Early detection can aid in personalized treatment decisions.
The INAVO120 study involved 325 patients and compared inavolisib with a placebo. Roche is also running two additional Phase III trials: INAVO121, assessing inavolisib with fulvestrant versus alpelisib plus fulvestrant, and INAVO122, evaluating it with pertuzumab plus trastuzumab for HER2-positive disease.
This approach addresses the unmet need for effective treatments in hormone receptor-positive breast cancer, which represents around 70% of cases.
