Puma Biotechnology Announced Presentation of Findings From Phase II Study Of Alisertib In Endocrine-Resistant Metastatic Breast Cancer ASCO 2024

Author: Charles Gross | June 02, 2024 10:03am

Puma Biotechnology, Inc. (NASDAQ:PBYI), a biopharmaceutical company, announced the presentation of biomarker findings from a Phase II randomized clinical trial of alisertib alone vs. alisertib + fulvestrant for the treatment of patients with endocrine and CDK4/6 inhibitor (CDK 4/6i) resistant, human epidermal growth factor receptor 2-negative (HER2-negative), hormone receptor-positive metastatic breast cancer (TBCRC 041; Clinicaltrials.gov identifier NCT02860000) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting currently being held in Chicago. The Phase II trial was conducted through the Translational Breast Cancer Research Consortium (TBCRC). Results were published by Tufia Haddad et al. (JAMA Oncology, March 2023) and reported promising clinical activity in both arms (overall response rate 19.6% vs. 20.0% and median progression-free survival 5.6 months vs. 5.4 months for alisertib vs. alisertib + fulvestrant, respectively) and a tolerable safety profile.

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