Puma Biotechnology Announces Presentation of Biomarker Findings from a Phase II Study of Alisertib with Paclitaxel versus Paclitaxel Alone in Metastatic or Locally Recurrent Breast Cancer at the 2023 ASCO Annual Meeting
(Jama Network Open, April 2021) and showed that the addition of alisertib to paclitaxel improved progression-free survival (PFS) among enrolled patients compared with paclitaxel alone (HR, 0.56; 95%CI, 0.37-0.84; P = .005).
- (Jama Network Open, April 2021) and showed that the addition of alisertib to paclitaxel improved progression-free survival (PFS) among enrolled patients compared with paclitaxel alone (HR, 0.56; 95%CI, 0.37-0.84; P = .005).
- No mutations were significantly associated with response or resistance to alisertib plus paclitaxel, including those in PIK3CA, TP53, AKT1, HER2, and CDH1.
- Increased MYC RNA expression was not observed in patients who did not appear to benefit from alisertib plus paclitaxel.
- This biomarker analysis will be very helpful to the design of the future trials of alisertib that we are planning in hormone receptor positive HER2-negative breast cancer.”