Core Insights - Roche announced positive final results from the phase III INAVO120 study, demonstrating 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][3][4] Group 1: Study Results - The Itovebi-based regimen showed 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 and a p-value of 0.0190 [1][4] - The regimen also demonstrated 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 [1][4] - Objective response rates improved significantly, and the time to chemotherapy was delayed by approximately two years, with a stratified HR of 0.43 [1][4] Group 2: Drug and Mechanism - Itovebi is an oral, targeted treatment specifically designed for patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative advanced breast cancer, which is often associated with poor prognosis [3][4] - The drug targets the PI3K alpha isoform, offering a unique mechanism of action that facilitates the degradation of mutated PI3K alpha, differentiating it from other PI3K inhibitors [4][3] Group 3: Regulatory Status and Future Studies - Itovebi is already approved in several countries, including the United States, Canada, and China, and has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use [1][4] - Additional phase III studies (INAVO121, INAVO122, INAVO123) are ongoing to explore Itovebi in various combinations for PIK3CA-mutated breast cancer [2][4]
New data show Roche's Itovebi significantly extended survival in a certain type of HR-positive advanced breast cancer