Genentech Therapeutics’s Phase III trial of Itovebi in patients with certain types of metastatic breast cancer has met the gold standard oncology endpoint of overall survival (OS) while also delaying disease progression.
Further results from the randomised, double-blind trial (NCT04191499) showed that Itovebi, otherwise known as inavolisib, when used in combination with Ibrance (palbociclib) and Faslodex (fulvestrant) met its secondary endpoint by showing a statistical and clinically meaningful benefit in OS in patients living with PIK3CA-mutated, hormone receptor (HR) positive, human epidermal growth factor receptor 2 negative (HER2) negative breast cancers.
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This news comes three months after the US Food and Drug Administration (FDA) approved the Itovebi combination as a first-line therapy based on this Phase III trial. The combination therapy is approved for patients with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer.
Primary analysis from the INAVO120 trial was published in December 2023 found the Itovebi combination regimen reduced the risk of disease worsening or death by 57% compared with Ibrance and Faslodex alone. At the time of the primary analysis, data on the secondary endpoint of OS was still immature.
In the secondary analysis, the company added that no new safety signals have been discovered since publishing its primary analysis.
Chief medical officer for the Roche subsidiary, Levi Garraway, said: “These findings underscore our ambition to improve survival rates for people with breast cancer. The Itovebi-based regimen has the potential to become the new standard of care for these patients.
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By GlobalData“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.”
The INAVO120 trial comes as part of a series of trials examining Itovebi with Ibrance and Faslodex against placebo across a number of HER2- and HR-positive cancers. Of the still ongoing trials, INAVO121 (NCT05646862) is examining the combination treatment following cyclin-dependent kinase 4/6 inhibitor and endocrine combination therapy. The INAVO122 trial (NCT05894239) examines the regimen in combination with HER2 blockade versus dual HER2 blockade. Meanwhile, the INAVO123 trial (NCT06790693) was in combination with CDK4/6i and letrozole.
Now, the company has said that a full analysis of the secondary endpoint will be discussed at an upcoming meeting. Research by GlobalData estimates that Itovebi is estimated to earn approximately $164m in sales by the end of 2025, with the drug forecasted to reach blockbuster status, with sales set to rise to $1.3bn by the end of 2030.
GlobalData is the parent company of Clinical Trials Arena.
Elsewhere in the world of HER2-related cancers, MSD and Eisai have announced mixed results from a Phase III trial of a Keytruda (pembrolizumab) combination as a first-line treatment for patients with HER2 negative gastroesophageal adenocarcinoma.
