Pharma Focus Asia

Biostar Pharma Announces Approval of Utidelone Injectable (UTD1) Phase 2/3 Multi-National Clinical Trial

Friday, June 16, 2023

Biostar Pharma has announced that the FDA has approved the Investigational New Drug (IND) application for a phase 2/3 clinical trial of the core product, utidelone injectable (UTD1), in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). 

The trial, designated as BG01-2202, will be a multi-national, open-label, randomised, controlled study comparing utidelone injectable (UTD1) with docetaxel.

The study will be conducted at approximately 50 sites across 10 countries and regions, including the United States, Europe, and Asia-Pacific. The purpose of this trial is to evaluate the efficacy and safety of utidelone injectable (UTD1) in comparison to docetaxel for the treatment of NSCLC.

In that trial, utidelone was tested as a single agent in patients with advanced NSCLC who had previously received at least two systemic regimens, including platinum-containing chemotherapy or targeted therapy. The results of the phase 2 trial demonstrated a 19.0% objective response rate (ORR), 81.0% disease control rate (DCR), a median progression-free survival (PFS) of 4.37 months, and a 12-month overall survival (OS) rate of 71%.

Utidelone is a genetically engineered epothilone analog derived from Biostar's synthetic biology technology platform. It belongs to a class of microtubule-targeting agents called epothilones, which have different mechanisms of action compared to taxanes. The development of utidelone aims to overcome drug resistance commonly associated with taxanes. 

Utdelone has demonstrated advantages such as overcoming taxane resistance, low hematological toxicity suitable for long-term exposure, and the ability to cross the blood-brain barrier for the prevention and treatment of tumor brain metastasis.

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