(BRIEF) Roche announced promising results from the phase III INAVO120 study, which evaluated inavolisib in combination with palbociclib (Ibrance®) and fulvestrant as first-line treatment for people with a PIK3CA mutation and hormone receptor (HR)-positive, HER2. -Negative, endocrine-resistant, locally complex or metastatic breast cancer. The combination cure demonstrated a 57% relief in the threat of disease progression or death compared to palbociclib and fulvestrant alone. The study also reported positive trends in overall survival and objective reaction rate. , duration of reaction and rate of clinical benefits. The protection profile of Inavolisib was consistent with known profiles of individual treatments. PIK3CA mutations, discovered in approximately 40% of HR-positive breast cancers, can lead to uncontrolled tumor expansion and resistance. to endocrine therapies. Roche plans to submit the knowledge to the health government to potentially make this remedy an option for patients in the near future.
(PRESS RELEASE) BASEL, Dec. 9, 2023 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) reported positive effects from the Phase III INAVO120 study comparing inavolisib in combination with palbociclib (Ibrance®) and fulvestrant as a first-line remedy for others with PIK3CA-mutated, hormone receptor-positive, HER2-negative, endocrine-resistant, locally advanced, or metastatic PIK3CA-mutant breast cancer. 1
The combination of inavolisib reduced the threat of disease worsening or death (progression-free survival; PFS) by 57% compared with palbociclib and fulvestrant alone (15. 0 months vs. 7. 3 months; threat index [HR] = 0. 43, 95% CI 0. 32-0. 59, p<0. 0001). Consistent benefits across all subgroups. Knowledge of overall survival (OS) was immature at this time, but a transparent positive trend was observed (stratified HR = 0. 64, 95% CI 0. 43-0. 97, P = 0. 0338 (cut-off 0. 0098)). The operating system will continue until the next scan. The data available for other secondary endpoints in this research showed clinically significant increases in objective reaction rate, reaction duration, and clinical advantage rate. 1
“The importance of the PI3K pathway has long been identified in many cancers, and inavolisib has the potential to reshape the way breast cancer is treated in patients whose tumors harbor PIK3CA mutations,” said Levi Garraway, M. D. , Ph. D. , chief medical officer and chief medical officer at Roche. The clinically significant advantages seen with inavolisib demonstrate its potential for a new popular care in this patient population and build on our commitment to better outcomes for all types of breast cancer. We hope to make inavolisib available to patients as soon as possible. as much as possible. “
The combination of inavolisib was well tolerated and adverse events were consistent with the known protection profiles of the individual drugs in the study, with no new protective signals observed. 1 Maximal and non-unusual grade 3-4 adverse reactions (≥ 5%) with mixture inavolisib compared with palbociclib and fulvestrant alone were neutropenia (80. 2% vs. 78. 4%), thrombocytopenia (14. 2% vs. 4. 3%), anemia (6. 2% vs. 1. 9%), stomatitis (5. 6% vs. 0), and hyperglycemia. (5. 6% vs. 0). 1 The attrition rate in the inavolisib treatment organization was 6. 8%, compared with 0. 6% for palbociclib and fulvestrant alone. 1
Inavolisib, an investigational oral treatment, is currently in three phase III clinical trials in people with complex or metastatic PIK3CA-mutated breast cancer (INAVO120, INAVO121, INAVO122). 6 to 8 PIK3CA mutations are found in approximately 40% of RHs. positive breast cancers and can lead to a mutation in the PI3Kα protein, which contributes to uncontrolled tumor growth, disease progression, and resistance to endocrine treatments. 2,3
Data from the INAVO120 study will be presented to the health government in order to offer this potential treatment option to patients as soon as possible.
The study included 325 patients, who were randomly assigned to either the experimental treatment group or the control treatment group. The primary endpoint is progression-free survival, as assessed by the investigators, explained as the time from randomization in the clinical trial to when the disease progresses or a patient dies from any cause. Secondary endpoints include overall survival, objective reaction rate, and clinical advantage rate.
Inavolisib is currently in 3 Roche-sponsored phase III clinical studies in complex or metastatic breast cancer with PIK3CA mutation:
In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.
Genentech, in the United States, is a company wholly owned by the Roche Group. Roche is the majority shareholder of Chugai Pharmaceutical, Japan.
For more information, visit www. roche. com.
All trademarks used or discussed in this press release are by law.
Media Contacts:
ORIGIN ROCK
MORE ON ROCHE, ETC.:
EuropaWire (EW) is, in fact, the first pan-European press release and press release distribution service for Europe and the European Union, which aims to consolidate Europe’s global voice of news agencies and the media. Submission forms, flexible PR pricing and budgets, granular targeting, unlimited maximum success across countries, markets, verticals, sectors, audiences, languages, etc. , translation and localization for greater local PR impact, detailed distribution, reporting, metrics. and insights, adding measured PR success, reads, interactions, impact, etc. , with no limits on words, images, and multimedia to accompany your post, among other things. Your press releases will be among the largest press releases and top vital companies, brands and establishments in Europe.
HOW DO I GET STARTED?