Alisertib

A phase 2 study, ALISCATM-Breast1, has begun for HR-positive, HER2-negative metastatic breast cancer patients to evaluate alisertib, an Aurora A kinase inhibitor. The study aims to determine the optimal dose of alisertib plus endocrine therapy, with main goals including objective response rate, duration of response, disease control rate, progression-free survival, and overall survival. Initial data is expected in 2025.

Puma Biotechnology initiates ALISCA™-Breast1 Phase II trial of alisertib combined with endocrine therapy for HR+, HER2-negative recurrent or metastatic breast cancer patients previously treated with CDK 4/6 inhibitors. The trial aims to determine the optimal alisertib dose and evaluate efficacy endpoints within biomarker subgroups, with initial data expected in 2025.

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Puma Biotechnology initiates Phase II trial of alisertib with endocrine therapy for HR+, HER2-negative metastatic breast cancer patients previously treated with CDK 4/6 inhibitors.

Puma Biotechnology initiates ALISCA-Breast1 Phase II trial of alisertib with endocrine therapy for HR+/HER2- recurrent/metastatic breast cancer post-CDK 4/6 inhibitors. Up to 150 patients will be randomized to receive alisertib at 30 mg, 40 mg, or 50 mg twice daily in 28-day cycles. Puma will analyze biomarkers to correlate with response and plans interim safety/efficacy analysis. Future plans include potential FDA approval pathway and a pivotal Phase III trial.