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Puma Biotechnology Announces Presentation of Findings from a Phase II Study of Alisertib in Endocrine-Resistant Metastatic Breast Cancer (TBCRC 041)
LOS ANGELES--(BUSINESS WIRE)-- Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the presentation of biomarker findings from a
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[{"type":"text","content":" LOS ANGELES--(BUSINESS WIRE)--\nPuma 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.\n\n\nThe 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.\n\n\nSomatic 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).\n\n\nCirculating 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","length":2568,"tagName":"div"}]