New analysis asserts survival benefit for Roche breast cancer therapy
Posted: 28 January 2025 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
The new data highlights the potential of the ItovebiTM (inavolisib)-based regimen as a new standard of care in advanced PIK3CA-mutated, HR-positive, HER2-negative breast cancer.
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Updated Phase III analysis show that Itovebi TM (inavolisib) in combination with palbociclib (Ibrance®) and fulvestrant provided a statistically significant and clinically meaningful overall survival benefit in a type of HR-positive advanced breast cancer. This was compared to palbociclib and fulvestrant only.
The combination treatment more than doubled progression-free survival, according to Roche’s Phase III INAVO120 study results in PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, endocrine-resistant, locally advanced or metastatic breast cancer.
Itovebi is an oral treatment with best-in-class potential and could provide well-tolerated, durable disease control, according to Roche. The company also noted the drug’s unique mechanism of action in enabling degradation of mutated PI3K alpha.
This is based on data presented at the San Antonio Breast Cancer Symposium, Abstract #P5-17-05 in 2020 and Abstract PD4-14 in 2017.
the Itovebi-based regimen has the potential to become the new standard of care for patients with this breast cancer indication”
Prior primary analysis showed that the Itovebi-based regimen reduced the risk of disease worsening or death by 57 percent compared with palbociclib and fulvestrant alone (15.0 months vs. 7.3 months) in the first-line setting. While this data was immature, a clear positive trend was observed, Roche confirmed.
Itovebi – a rising player in the breast cancer field
“The INAVO120 overall survival results show that the Itovebi-based regimen not only delayed disease progression, but also helped people with advanced HR-positive, PIK3CA-mutated breast cancer live longer,” commented Dr Levi Garraway, PhD, Roche’s Chief Medical Officer and Head of Global Product Development.
Dr Garraway asserted that the Itovebi-based regimen has the potential to become the new standard of care for patients with this type of breast cancer.
Data from the INAVO120 study was published in the New England Journal of Medicine.
Full results from the overall survival analysis will be presented at an upcoming medical meeting, according to Roche.
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Anti-Cancer Therapeutics, Big Pharma, Clinical Development, Clinical Trials, Data Analysis, Drug Development, Drug Safety, Industry Insight, Research & Development (R&D), Therapeutics
