FDA approves Biostar’s Phase II/III plans with utidelone injectable for NSCLC

Synthetic biology biopharma Biostar Pharma announced is ready to advance its utidelone injectable (UTD1) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), following approval from the US Food and Drug Administration (FDA) for the study.

UTD1 is a microtubule stabilising agent, acting as an anti-neoplastic drug. It is currently marketed for breast cancer treatment in China and trialled globally for treating pancreatic, gastric, bile duct, ovarian, prostate and breast cancers, as well as solid tumours.

Designated as BG01-2202, this latest trial will be an open-label, randomised, controlled clinical study of UTD1 versus chemotherapy drug docetaxel. It will be conducted at 50 sites across ten countries in the US, Europe and Asia Pacific regions. A Phase III study to evaluate UTD1 versus docetaxel in patients that have failed chemotherapy with a platinum-containing regimen is also currently underway in China.

Biostar Pharma chairman Dr Li Tang said this study approval was a milestone in the UTD1’s global development, and expressed an interest in partnering with other pharmaceutical companies to bring the treatment to market.

Biostar plans to enrol 90 patients for the Phase II trial with ORR (objective response rate) as the primary endpoint. A further 670 patients will be studied in the Phase III portion with OS (overall survival) as the primary endpoint and PFS (progression-free survival), ORR, etc. as the secondary endpoints.

This latest study approval follows a previous open-label, multi-centre Phase II trial conducted in China (NCT03693547). It studied UTD1 as a single agent to treat patients with advanced NSCLC who had received at least two prior systemic regimens including platinum-containing chemotherapy or targeted therapy. Promising results were observed, with outcomes of 19.0% ORR, 81.0% DCR (disease control rate), 4.37 months of median PFS, 71% of 12-month OS rate and median OS not being reached by the cut-off date.