China’s Beijing Biostar Technologies Ltd (HKG: 2563) announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a global multi-center Phase II/III regulatory study, dubbed BG02-2404. The study will evaluate utidelone in combination with capecitabine and oxaliplatin as a first-line treatment for PD-L1 negative locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
Promising Phase II Results and FDA Designation
In a prior Phase II study, utidelone combined with a PD-1 inhibitor and oxaliplatin demonstrated significant efficacy in first-line unresectable locally advanced or recurrent/metastatic HER2 negative gastric cancer. Among 23 subjects who completed efficacy evaluation, 15 achieved partial remission and eight achieved disease stability, resulting in an objective remission rate of 65.2% and a clinical benefit rate of 100%. These results led to the drug being awarded orphan drug designation (ODD) for advanced gastric cancer by the FDA.
Utidelone Background and Trial Design
Utidelone is a genetically engineered epothilone derivative that was approved in China in 2021 for the treatment of recurrent or metastatic advanced breast cancer. The Phase II portion of the BG02-2404 study is expected to enroll 78 subjects across 12 centers in the United States and 15 centers in Asia. It is primarily designed to assess the safety, efficacy, and pharmacokinetics of the utidelone combination. The Phase III portion, anticipated to enroll 700 participants, will be conducted across 30 centers in the United States, 53 centers in Asia, and 47 centers in Europe and other countries and regions.-Fineline Info & Tech
