Clinical Trials

Biopharmaceutical company Puma Biotechnology has announced the initiation of its ALISertib in Cancer (ALISCATM-Breast1) phase 2 trial of alisertib in combination with endocrine therapy. Based on the outcomes of the trial, the company anticipates to meet with the US Food and Drug Administration (FDA) regarding an approval pathway.

ALISCATM-Breast1 will enrol up to 150 patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-negative) recurrent or metastatic breast cancer who have previously been treated with CDK 4/6 inhibitors and received at least two prior lines of endocrine therapy in the recurrent or metastatic setting. These patients will be randomised to receive a 30mg, 40mg or 50mg dose of alisertib two times a day on days one-three, eight-ten and 15-17 in a 28-day cycle.

Alan H Auerbach, CEO, president and founder of Puma Biotechnology, stated, “We are excited to initiate this phase 2 trial and to move forward with the development of alisertib in HER2-negative HR+ metastatic breast cancer. We believe that the data from the previous trial of alisertib monotherapy (published in Lancet Oncology) as well as the TBCRC 041 trial (published in JAMA Oncology), which tested alisertib alone and with fulvestrant, and the randomised trial of alisertib plus paclitaxel versus paclitaxel alone (published in JAMA Network Open) have demonstrated that alisertib is active in patients with HER2-negative, HR+ metastatic breast cancer and in biomarker focused subgroups. We look forward to enrolment in the ALISCATM-Breast1 trial and anticipate that we should have initial data from this trial in 2025.”

Puma Biotechnology is based in Los Angeles, CA, US.