Genentech, part of the Roche Group, has presented compelling results from the Phase III INAVO120 study, evaluating the effectiveness of inavolisib in combination with palbociclib (Ibrance) and fulvestrant for treating a specific group of breast cancer patients. The study focuses on individuals with PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, endocrine-resistant, locally advanced or metastatic breast cancer.

The INAVO120 study found that the inavolisib combination reduced the risk of disease worsening or death (progression-free survival; PFS) by 57% compared to the control group, marking a significant advancement in breast cancer treatment. The overall survival (OS) data, while still immature, showed a positive trend, signaling the potential long-term benefits of this treatment approach.

Levi Garraway, Genentech’s Chief Medical Officer, highlighted the significance of the PI3K pathway in cancer treatment and the potential of inavolisib to revolutionize breast cancer therapy. He emphasized the meaningful clinical benefits observed with the inavolisib combination, underlining Genentech’s commitment to improving outcomes across all types of breast cancer.

Inavolisib, an investigational oral therapy, is part of three Phase III clinical studies targeting PIK3CA-mutated locally advanced or metastatic breast cancer. Approximately 40% of HR-positive breast cancers exhibit PIK3CA mutations, contributing to tumor growth and resistance to endocrine-based treatments.

The INAVO120 study is a randomized, double-blind, placebo-controlled trial involving 325 patients. Its primary endpoint is progression-free survival, with secondary endpoints including overall survival, objective response rate, and clinical benefit rate. Inavolisib targets specific degradation of mutant PI3K alpha, differentiating it from other PI3K inhibitors due to its high potency and specificity.

This study’s results will be submitted to health authorities, potentially bringing a new treatment option to patients soon. Genentech’s ongoing research and development in this area continue to provide hope for advanced cancer treatments, showcasing the company’s dedication to pioneering medical breakthroughs in oncology.

  Breast Cancer, fulvestrant, Genentech, IBRANCE, inavolisib, Levi Garraway, palbociclib, Roche