Puma Biotechnology

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.

Puma Biotechnology initiates Phase II trial, ALISCA-Breast1, to evaluate oral alisertib, a selective aurora kinase A inhibitor, in combination with endocrine therapy for HR+, HER2-negative recurrent or metastatic breast cancer. The trial will enroll up to 150 subjects, randomly assigned to three dosing regimens of alisertib, with primary endpoints including response duration, objective response rate, disease control rate, overall survival, and progression-free survival. Biomarker analysis will be conducted concurrently, aiming to identify optimal dosages and potential biomarker-response correlations. Initial data is expected in 2025, with plans for a pivotal Phase III trial following dose determination.

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.

Puma Biotechnology initiates Phase II trial of alisertib with endocrine therapy for HR+/HER2- recurrent/metastatic breast cancer, previously treated with CDK 4/6 inhibitors. The ALISCA-Breast1 trial will randomize up to 150 patients to receive alisertib at 30 mg, 40 mg, or 50 mg twice daily in a 28-day cycle, combined with endocrine therapy. Primary endpoints include response rate, duration, disease control, progression-free survival, and overall survival. Puma will analyze biomarkers and perform an interim safety/efficacy analysis, aiming for FDA approval and a pivotal trial.

Puma Biotechnology initiates ALISCA™-Breast1 Phase II trial of alisertib with endocrine therapy for hormone receptor-positive, HER2-negative metastatic breast cancer. The trial will enroll up to 150 patients previously treated with CDK 4/6 inhibitors and at least two endocrine therapies, randomized to receive alisertib at 30mg, 40mg, or 50mg doses. Primary endpoints include objective response rate, duration of response, disease control rate, progression-free survival, and overall survival. Initial data expected in 2025, with plans to discuss potential approval pathways with the FDA.