SWITZERLAND – Roche’s inavolisib, an oral PI3 kinase (PI3K) inhibitor, has been granted a priority review by the US Food and Drug Administration (FDA) in combination with Pfizer’s Ibrance (palbociclib) and fulvestrant as a treatment for breast cancer.

This combination therapy is designed for adult patients with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer who have experienced recurrence within 12 months of completing adjuvant endocrine treatment.

The priority review status was awarded based on the positive results from the Phase III INAVO120 trial. 

This trial demonstrated a significant improvement in progression-free survival (PFS) for patients receiving the inavolisib-based regimen compared to those receiving the standard combination of fulvestrant and Ibrance. 

The PFS was 15 months for the inavolisib combination, compared to 7.3 months for the standard combination. The overall survival (OS) data were not fully mature during primary analysis, but a clear positive trend was observed.

“We welcome the FDA’s Priority Review designation for inavolisib, which underscores the urgency to bring this potential best-in-class treatment option to patients as quickly as possible,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development.

“The addition of inavolisib to standard of care treatment significantly delayed disease progression in the first-line setting and has the potential to extend survival for people with metastatic breast cancers that harbor PIK3CA mutations.”

The PIK3CA mutation is found in approximately 40% of HR-positive metastatic breast cancers. Early testing for mutations like PIK3CA can help identify people who may benefit from targeted therapy before initiating first-line treatment.

Roche plans to present the data at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held from May 31 to June 04. 

The company is also investigating inavolisib as part of different combination treatments for PIK3CA-mutated advanced or metastatic breast cancer, including a Phase III trial in combination with the company’s breast cancer combination therapy Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzfx).

Roche’s inavolisib has been designed to help minimize the overall burden and toxicity of treatment. 

It is differentiated from other PI3K inhibitors due to its high potency and specificity for the PI3K alpha isoform versus other isoforms and its unique mechanism of action that facilitates the degradation of mutated PI3K alpha. 

The company plans to file for regulatory approval for inavolisib with other global health authorities, including the European Medicines Agency.

The FDA has set a target action date of November 27, 2024, for evaluating the combination therapy. 

Priority Review designation is granted to medicines that the FDA has determined to have the potential to significantly improve the treatment, prevention, or diagnosis of a disease. 

Roche’s inavolisib has been granted FDA Breakthrough Therapy Designation based on INAVO120, the 29th for Roche’s oncology portfolio.

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