The US FDA has cleared the IND application for conducting a P-II study of utidelone injection (UTD1) for HER2- breast cancer brain metastasis (BCBM)
The P-II (BG01-2402) trial assesses the intracranial and systemic efficacy of Utidelone Injection + capecitabine to treat patients (n=120) with HER2- BCBM across the US. 1EP includes CNS-ORR & 2EPs are PFS, DOR & OS
A P-II study, highlighted at ASCO 2024, showed utidelone with bevacizumab had a CNS-ORR of 42.6%, mPFS of 7.7mos. & 12mos. OS rate of 74.4% in HER2- BCBM patients (n=47). In the HR-/HER2- subgroup, CNS-ORR was 55% with mPFS of 8.4mos.
Ref: PR Newswire | Image: Biostar Pharma
Related News:- Biostar Pharma’s Utidelone Injectable Receives the USFDA’s Orphan Drug Designation for Treating Breast Cancer Brain Metastasis
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