Core Insights - Roche announced positive topline results from the phase III INAVO120 study, demonstrating that the Itovebi-based regimen significantly improves overall survival (OS) for patients with advanced PIK3CA-mutated, hormone receptor-positive, HER2-negative breast cancer compared to standard treatments [1][2][7] Group 1: Study Results - The INAVO120 study met its key secondary endpoint, showing a statistically significant OS benefit with the Itovebi-based regimen, which reduced the risk of disease worsening or death by 57% compared to palbociclib and fulvestrant alone [2][7] - The primary analysis indicated that the Itovebi-based regimen more than doubled progression-free survival, with a median of 15.0 months versus 7.3 months for the control group [2][7] - The study included 325 patients, with the primary endpoint being progression-free survival, and secondary endpoints including overall survival and objective response rate [8] Group 2: Regulatory Approval and Future Studies - The U.S. FDA approved the Itovebi-based regimen in October 2024 for treating adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative breast cancer [3] - Roche is conducting four additional phase III clinical studies to further investigate Itovebi in various combinations for PIK3CA-mutated breast cancer [4][8] - The full results from the OS analysis will be presented at an upcoming medical meeting, indicating ongoing commitment to transparency and scientific communication [2][7] Group 3: Product Information - Itovebi is an oral, targeted treatment designed to provide durable disease control and improved outcomes for patients with PIK3CA-mutated breast cancer, addressing a significant unmet need in this patient population [5][9] - The drug is differentiated from other PI3K inhibitors due to its high potency and specificity for the PI3K alpha isoform, which is crucial for targeting the underlying mutation in these cancers [5][9] Group 4: Company Background - Roche has over 30 years of experience in advancing breast cancer research, aiming to improve treatment outcomes for various subtypes, including hormone receptor-positive breast cancer, which accounts for approximately 70% of all breast cancer cases [10][9] - The company is committed to personalized healthcare and aims to transform healthcare delivery through innovative medicines and diagnostics [11][12]
Roche's Itovebi demonstrated statistically significant and clinically meaningful overall survival benefit in a certain type of HR-positive advanced breast cancer