Puma Biotechnology Commences the P-II (ALISCA-Breast1) Study of Alisertib in HR-Positive, HER2-Negative Metastatic Breast Cancer
Shots:
- The company has commenced P-II (ALISCA-Breast1) of alisertib (30, 40, or 50mg, BID) + endocrine therapy, with biomarker analysis, in HR+/HER2- metastatic breast cancer patients (n=150), previously treated with CDK 4/6 inhibitors & at least 2 endocrine therapies
- Optimal dose will be determined, with 1EPs as ORR, DoR, DCR, PFS & OS; these EPs will be assessed in biomarker subgroups alongside the trial as a 2EP to establish correlations with response. Patient recruitment & initial data is expected in 2025
- After determining the optimal dose, Puma will work with regulators to plan its pivotal P-III trial, followed by a discussion on approval pathway with the US FDA based on these results in this population
Ref: Puma Biotechnology| Image: Puma Biotechnology
Related News:- Puma Biotechnology Publishes P-II Trial (TBCRC041) Results of Alisertib for Endocrine-Resistant Advanced Breast Cancer in JAMA Oncology
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
