SHERIDAN, WYOMING – NOVEMBER 05, 2024 – In a landmark phase III study published in the New England Journal of Medicine, Roche's Itovebi (inavolisib) has demonstrated a significant breakthrough in the treatment of HR-positive advanced breast cancer. The Itovebi-based regimen more than doubled progression-free survival compared to the standard treatment of palbociclib and fulvestrant alone.
The INAVO120 study evaluated Itovebi in combination with palbociclib and fulvestrant in patients with HR-positive, HER2-negative breast cancer with a PIK3CA mutation, one of the most common mutations in this type of cancer. The results were striking, with the Itovebi-based regimen reducing the risk of disease progression or death by 57%. [cite: 1, 2, 7]
Dr. Komal Jhaveri, a principal investigator of the INAVO120 study, expressed confidence that this Itovebi-based regimen could become a new first-line standard of care for this patient population. The FDA recently approved the Itovebi-based regimen for first-line treatment of individuals with this specific type of breast cancer. [cite: 1, 2, 3, 5, 6]
The INAVO120 study included 325 patients who were randomly assigned to either the investigational or control treatment arm. The primary endpoint was progression-free survival, while secondary endpoints included overall survival, objective response rate, and clinical benefit rate. [cite: 17, 18, 19, 20]
"With a doubling of progression-free survival and consistent benefits in people whose disease had spread to multiple challenging-to-treat locations, including the liver and lungs, these INAVO120 data are significant for patients," said Dr. Jhaveri. [cite: 5]
The study results showed that the Itovebi-based regimen provided consistent benefits across all pre-specified subgroups, including those with difficult-to-treat disease. While overall survival data were immature at the time of analysis, a clear positive trend was observed. [cite: 7, 8]
Roche's Chief Medical Officer and Head of Global Product Development, Dr. Levi Garraway, highlighted the transformative potential of the Itovebi-based regimen. "This new treatment exemplifies our ambition to target specific disease pathways more effectively and improve outcomes in people with breast cancer, while also emphasizing the importance of comprehensive testing for mutations like PIK3CA at the time of diagnosis," he said. [cite: 10, 11]
The PIK3CA mutation is prevalent in approximately 40% of HR-positive metastatic breast cancers and is associated with a poor prognosis. Historically, the use of PI3K targeted therapy in the first-line advanced setting has been limited, and testing for PIK3CA mutations at diagnosis is uncommon. [cite: 12, 13]
Early biomarker testing with an FDA-approved test before first-line treatment is crucial to identify individuals who may benefit from targeted therapies like Itovebi. [cite: 14]
Currently, Itovebi is being investigated in three company-sponsored phase III clinical studies for PIK3CA-mutated locally advanced or metastatic breast cancer. Roche is exploring additional studies in breast cancer and other tumor types with the goal of expanding the benefits of this targeted therapy to more patients with PIK3CA mutations. [cite: 15, 16]
Roche, founded in 1896, has a long-standing commitment to breast cancer research. The company has been at the forefront of developing medicines and companion diagnostic tests that have led to breakthrough outcomes in various types of breast cancer. [cite: 26, 27]
"As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including oestrogen receptor-positive breast cancer, which is a form of hormone receptor-positive breast cancer, the most prevalent type of all breast cancers," said Dr. Garraway. [cite: 28]