Puma Biotechnology Announces Presentation of Findings from a Phase II Study of Alisertib in Endocrine-Resistant Metastatic Breast Cancer (TBCRC 041)

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LOS ANGELES --(BUSINESS WIRE)-- 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. The poster (Abstract #1037, Poster Bd #15), entitled, “Molecular profiling of serial liquid biopsy specimens utilizing cell free DNA (cfDNA) and circulating tumor cells (CTCs) in TBCRC 041: A phase II study of alisertib in endocrine resistant metastatic breast cancer (MBC),” was presented at the Breast Cancer – Metastatic Poster Session by Karthik Giridhar , MD, Mayo Clinic , on June 2 at 9:00 a.m. CDT . Somatic mutations from cell-free DNA derived from pre-treatment plasma were identified in ESR1 (n=45; 56.38%), PIK3CA (n=39; 48.8%), PTEN (n=13; 16.3%), and AKT1 (n=9; 11.3%). Patients with PIK3CA mutation experienced decreased progression-free survival (PFS) (HR 1.8; 95%CI: 1.1 -2.9, p=0.0225) while ESR1 mutation did not impact PFS (p=0.594). Circulating tumors cells (CTCs) and methylated tumor fraction percentage (mTF) were evaluated in pre-treatment and at the end of cycle 1 (EOC1). Lower CTCs in pre-treatment samples were associated with longer PFS (7.4 months for CTC count 1%, HR 3.0; 95% CI: 1.6-5.2, p

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