Roche has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for its inavolisib combination to treat advanced hormone receptor-positive, breast cancer patients with a PIK3CA mutation.
The status has been granted to inavolisib in combination with palbociclib (Ibrance) and fulvestrant to treat adults having hormone receptor-positive, human epidermal growth factor receptor 2-negative (HER2-negative), locally advanced or metastatic breast cancer.
These patients must have the disease recurrence on or within 12 months of completing adjuvant endocrine therapy.
The FDA’s decision is supported by findings from the Phase 3 randomised, double-blind, placebo-controlled INAVO120 trial.
The trial evaluated the efficacy and safety of inavolisib plus palbociclib and fulvestrant against placebo with palbociclib and fulvestrant in 325 patients.
The primary endpoint was defined as the progression-free survival and secondary endpoints include overall survival, objective response rate, and clinical benefit rate.
The inavolisib-based treatment significantly decreased the risk of disease progression or death by 57% compared to palbociclib and fulvestrant alone.
The overall survival (OS) data were immature at the time but showed a clear positive trajectory. Follow-up for OS is ongoing for the next analysis.
Roche chief medical officer and global product development head Levi Garraway said: “We are pleased that the FDA granted Breakthrough Therapy Designation for inavolisib in recognition of the substantial clinical benefit observed with this regimen.
“This promising inavolisib-based regimen could transform the PI3K inhibitor class, potentially becoming the standard of care for this patient population in the first-line setting.”
Roche said that the trial results underscore the potential of this inavolisib-based regimen to benefit patients with PIK3CA-mutated locally advanced or metastatic breast cancer.
Data from the INAVO120 study are also undergoing review by other global health authorities, including the European Medicines Agency.
Inavolisib is presently under investigation in three company-sponsored Phase 3 clinical trials for PIK3CA-mutated locally advanced or metastatic breast cancer to assess various combinations.
