ALISCATM-Breast1 Ph 2 Trial of Alisertib initiated in HR+ve, HER2-Negative Metastatic Breast Cancer
Alan H. Auerbach, Chief Executive Officer, President and Founder of Puma, stated, “We are excited to initiate this Phase II 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 randomized 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 enrollment in the ALISCATM-Breast1 trial and anticipate that we should have initial data from this trial in 2025.”
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