Core Insights - Roche announced positive final results from the phase III INAVO120 study, showing that Itovebi (inavolisib) in combination with palbociclib and fulvestrant reduced the risk of death by over 30% compared to palbociclib and fulvestrant alone, indicating a significant improvement in overall survival for patients with specific breast cancer subtypes [1][2][6] Group 1: Study Results - The Itovebi-based regimen demonstrated a median overall survival (OS) of 34.0 months compared to 27.0 months for the control group, with a stratified hazard ratio (HR) of 0.67, indicating a statistically significant improvement (p-value=0.0190) [2][3] - The regimen also showed a median progression-free survival (PFS) of 17.2 months versus 7.3 months in the comparator arm, with a stratified HR of 0.42 [2][3] - The objective response rate improved significantly, and the time to chemotherapy was delayed by approximately two years (stratified HR=0.43) [3] Group 2: Regulatory Status and Future Studies - Itovebi is approved in multiple countries including the United States, Canada, and China, and received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, with a final decision pending from the European Commission [4] - The INAVO120 study included 325 patients and is part of ongoing research, with three additional phase III studies (INAVO121, INAVO122, INAVO123) currently investigating Itovebi in various combinations for PIK3CA-mutated breast cancer [5][9] Group 3: Company Commitment and Background - Roche has been dedicated to advancing breast cancer research for over 30 years, focusing on improving treatment outcomes and quality of life for patients with hormone receptor-positive breast cancer [11] - The company aims to provide targeted therapies for patients with PIK3CA mutations, which are found in approximately 40% of HR-positive advanced breast cancers [6][10]