FDA allows Puma to proceed under IND with alisertib development for BC

Puma Biotechnology has been notified by the U.S. Food and Drug Administration FDA that its Investigational New Drug Application IND submission has been reviewed, and Puma can proceed with the clinical development of alisertib for the treatment of patients with human epidermal growth factor receptor 2-negative , hormone receptor-positive metastatic breast cancer in Puma’s Phase II ALISCA-Breast1 trial .This trial will investigate alisertib in combination with endocrine treatment in chemotherapy-naive patients with hormone receptor-positive, HER2-negative recurrent or metastatic breast cancer. Patients must have been previously treated with CDK 4/6 inhibitors and received at least two prior lines of endocrine therapy in the recurrent or metastatic setting to be eligible for the trial. Puma plans to initiate this trial in the second half of 2024. As a secondary endpoint, the Company will be evaluating each of these efficacy endpoints within biomarker subgroups in order to determine whether any biomarker subgroup correlates with response. The goal would be to enhance the efficacy in a biomarker subgroup to improve the efficacy of alisertib as previously seen in preclinical and clinical studies in other cancers, including breast cancer and small cell lung cancer. ..Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, “We are excited to move forward with the development of alisertib in HER2-negative hormone receptor-positive metastatic breast cancer. We believe that the data from TBCRC 041, which tested alisertib alone and with fulvestrant, and the randomized trial of alisertib plus paclitaxel versus paclitaxel alone have demonstrated that alisertib was active in patients with HER2-negative, hormone receptor-positive metastatic breast cancer and in biomarker focused subgroups. We also recognize our fiscal responsibility to the shareholders of the Company and will be carefully managing the development expenses for alisertib so as not to potentially negatively impact the Company’s profitability.”