PBYI Begins Phase II Study on Alisertib Combo in Breast Cancer

Core Insights - Puma Biotechnology has initiated the phase II ALISCA-Breast1 study to evaluate alisertib for treating metastatic breast cancer [1][2] - The study focuses on hormone receptor-positive, HER2-negative recurrent or metastatic breast cancer patients previously treated with CDK 4/6 inhibitors [2] - Initial data from the study is expected in 2025, with plans for a pivotal phase III study following the determination of the optimal dose [3][4] Study Objectives and Design - The main objective of the ALISCA-Breast1 study is to determine the optimal dose of alisertib in combination with selected endocrine therapy [3] - Primary endpoints include objective response rate, duration of response, disease control rate, progression-free survival, and overall survival [6] - The company will conduct an interim analysis to investigate the safety and efficacy of the study [7] Development and Market Potential - Puma Biotechnology in-licensed alisertib from Takeda in 2022, positioning it for potential use in various cancers [8] - Alisertib shows promise in HR-positive, HER2-negative breast cancer, triple-negative breast cancer, head and neck cancer, and small cell lung cancer [9] - Successful development of alisertib could enhance the company's standing in the anticancer drug market [9] Stock Performance - Year to date, Puma Biotechnology's shares have declined by 34.4%, compared to the industry's decline of 10.9% [5]