On December 16, 2025 Biostar Pharma, Inc., the U.S. wholly-owned subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. (Stock Code: 2563.HK), reported that the first patient has been dosed for one of its key oversea clinical studies: the U.S. pivotal clinical study (NCT06764940) of Utidelone Injection(UTD1) combined with capecitabine for the treatment of HER2-negative breast cancer brain metastases (BCBM).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The study adopts a two-stage design and plans to enroll approximately 120 subjects. The primary endpoint is the central nervous system objective response rate (CNS-ORR). Nearly 20 top tier clinical institutes across the United States are participating in the trial, including MD Anderson Cancer Center, John Hopkins Sidney Kimmel Comprehensive Cancer Center, City of Hope-Duarte, Robert H. Lurie Comprehensive Cancer Center at Northwestern University, University of Colorado Hospital, Augusta University, and University of California Los Angeles.
Utidelone’s unique physicochemical properties and insensitivity to P-glycoprotein-mediated efflux enable it to cross the blood-brain barrier (BBB) and prevent or treat brain metastases of solid tumors, setting it apart from taxanes, which are also microtubule stabilizers. A Phase II clinical study of utidelone combined with bevacizumab and chemotherapy for HER2-negative BCBM, which enrolled 34 subjects, was presented orally at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting [1]. The results showed a CNS-ORR of 67.6%, a central nervous system clinical benefit rate (CNS-CBR) of 88.2%, and a median central nervous system progression-free survival (CNS-PFS) of 15 months. The results of another Phase II clinical study of utidelone combined with bevacizumab for HER2-negative BCBM were published in JAMA Oncology in 2025 [2]. 47 subjects were recruited in the study, with a CNS-ORR of 42.6%, a median CNS-PFS of 10.6 months, and a median overall survival of 15.1 months. In both studies, most treatment-related adverse events (TRAEs) were Grade 1-2, controllable, and reversible. The U.S. FDA has also granted Utidelone orphan drug designation for the treatment of breast cancer brain metastases.
Approximately 20-50% of advanced breast cancer patients develop brain metastases [3]. Due to the presence of the BBB, many breast cancer treatments were unable to achieve effective concentrations intracranially, leading to generally poor prognoses for BCBM patients, particularly those with HER2-negative BCBM, whose median progression-free survival is only 2-6 months. However, there is currently no clearly effective drug therapy for HER2-negative BCBM, and no drugs worldwide have been approved for this indication, highlighting a significant and urgent unmet medical need. Utidelone has the potential to change this landscape, offering a new treatment option and hope for survival to these patients.
(Press release, Beijing Biostar Technologies, DEC 16, 2025, View Source [SID1234661469])