Genentech, a member of the Roche Group, has secured FDA approval for inavolisib, a PI3K inhibitor, in combination with palbociclib and endocrine therapy for the treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer whose tumors have a PIK3CA mutation, detected by an FDA-approved test, after progression on or following endocrine therapy. This approval marks a significant advancement in the treatment landscape for this specific subtype of breast cancer.
The approval was primarily based on the results of the Phase III INAVO120 trial. This trial evaluated the efficacy and safety of inavolisib in combination with palbociclib and endocrine therapy compared to palbociclib and endocrine therapy alone. The study demonstrated a statistically significant improvement in progression-free survival (PFS) in patients with PIK3CA-mutated HR+, HER2- advanced breast cancer. Detailed results from the INAVO120 trial indicated a hazard ratio of [insert actual HR value if available, e.g., 0.54] with a p-value of [insert actual p-value if available, e.g., <0.0001], signifying a clinically meaningful benefit.
"The approval of inavolisib offers a new targeted treatment option for patients with HR+, HER2- advanced breast cancer harboring PIK3CA mutations," said [Quote a relevant expert or Genentech representative if available]. "This approval underscores the importance of PIK3CA mutation testing in guiding treatment decisions and improving outcomes for these patients."
Breast cancer is a prevalent malignancy, and HR+, HER2- breast cancer represents a significant proportion of these cases. PIK3CA mutations are present in approximately 40% of HR+, HER2- breast cancers. These mutations activate the PI3K signaling pathway, contributing to cancer cell growth and resistance to endocrine therapy. The current treatment landscape includes endocrine therapy, CDK4/6 inhibitors, and other targeted therapies; however, resistance to these treatments often develops, highlighting the need for novel therapeutic strategies.
Inavolisib is an oral PI3K inhibitor specifically designed to target the PI3K pathway. By inhibiting this pathway, inavolisib aims to disrupt cancer cell growth and overcome resistance to endocrine therapy. The recommended dose of inavolisib is [insert dosage information, e.g., 400 mg orally once daily] in combination with palbociclib and endocrine therapy. Patients should be selected for treatment with inavolisib based on the presence of a PIK3CA mutation in their tumor, as detected by an FDA-approved test.
The INAVO120 trial enrolled patients with HR+, HER2- advanced breast cancer who had progressed on or after endocrine therapy. Key inclusion criteria included documented PIK3CA mutation status and measurable disease. The primary endpoint was progression-free survival, while secondary endpoints included overall survival, objective response rate, and safety. Common adverse events associated with inavolisib included [list common adverse events, e.g., diarrhea, rash, stomatitis].
This approval represents a significant step forward in personalized medicine for breast cancer, allowing clinicians to target a specific genetic mutation with a tailored therapeutic approach. Further research is ongoing to explore the potential of inavolisib in other cancer types and in combination with other therapies.
