Swiss pharmaceutical company Roche has reported positive data from the Phase III INAVO120 clinical trial of its investigational therapy, inavolisib, alongside palbociclib (Ibrance) and fulvestrant to treat locally advanced or metastatic breast cancer.

The randomised, placebo-controlled trial analysed the safety and efficacy of the combination therapy as a first-line treatment option compared with placebo plus palbociclib and fulvestrant. 

It enrolled 325 individuals with PIK3CA-mutated, hormone receptor (HR) positive, HER2-negative, endocrine-resistant, locally advanced or metastatic breast cancer. 

Progression-free survival (PFS) was the trial’s primary endpoint, while overall survival, objective response rate and clinical benefit rate were its secondary endpoints.

The inavolisib combination regimen offered ‘statistically significant and clinically meaningful’ improvement against the placebo arm in the first-line setting, thereby meeting the primary endpoint.

Roche noted that the data on overall survival was immature at the time of assessment but demonstrated a positive trend.

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By GlobalData

The combination treatment was also found to be well-tolerated, with any adverse events being in line with the known safety profiles of individual treatments.

Roche Global Product Development head and chief medical officer Levi Garraway said: “These pivotal study results for this inavolisib combination could represent a transformative medical advance for people with PIK3CA-mutated HR-positive breast cancer. 

“We look forward to expanding our portfolio of breast cancer medicines into the HR-positive space and bringing this potentially best-in-class new treatment option to patients as quickly as possible.”

Inavolisib is also being analysed in different combinations in two other Phase III trials in PIK3CA-mutated metastatic breast cancer patients.

In October this year, Roche reported that its Phase II Rainbowfish clinical trial of Evrysdi in babies with spinal muscular atrophy (SMA) met its primary endpoint.

The trial is designed to analyse the safety and efficacy of Evrysdi in patients aged from birth to six weeks with pre-symptomatic SMA.