Biostar Pharma-B (02563) has issued an announcement that the first patient has been successfully dosed in the Phase III clinical study (BG02-2601) of its core pipeline product Utidelone Capsules (UTD2) for the treatment of human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer, marking the official launch of the world's first pivotal registration clinical trial for an oral solid microtubule stabilizer.
The study is a randomized, controlled, non-inferiority bridging trial of Utidelone Capsules versus the already-marketed Utidelone Injection (UTD1), each combined with capecitabine (CAP), in HER2-negative advanced breast cancer patients who have previously received taxane or anthracycline treatment, with progression-free survival as the endpoint.
The trial is led by Academician Xu Binghe of the Cancer Hospital of the Chinese Academy of Medical Sciences, with more than 40 clinical research centers across the country participating.
Utidelone shares a similar mechanism of action with taxane drugs, but unlike taxanes, which are difficult to develop into oral formulations, Utidelone is not easily pumped out of cells by P-glycoprotein, giving it the advantage of oral administration and breaking through the difficulty barrier of developing oral formulations of traditional microtubule inhibitors.
Phase II data disclosed at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting showed that UTD2 combined with CAP achieved an objective response rate (ORR) of 52.3%, a disease control rate (DCR) of 88.6%, a median progression-free survival (PFS) of 8.25 months, and a median duration of treatment (DoT) of 9.0 cycles, with efficacy comparable to or slightly better than historical data for UTD1 combined with CAP; in terms of safety, UTD2 combined with CAP demonstrated outstanding advantages, particularly by significantly reducing the incidence of grade 3 or higher peripheral neuropathy from 25.1% with UTD1 combined with CAP to only 2.0%, while hematological toxicity remained at extremely low levels, with patient tolerability markedly improved.
UTD2 can help patients break free from long-term intravenous infusion and pre-treatment preparation, enabling home-based oral anti-tumor treatment, improving the quality of life and clinical benefits of patients living with tumors, and also providing a foundation for outpatient-based cancer treatment, reducing the pressure on medical resources and the burden on patients seeking medical care.
The company has conducted multiple Phase II and Phase III clinical studies on UTD2, covering multiple indications including advanced breast cancer, gastric cancer, ovarian cancer, adjuvant intensification for triple-negative breast cancer, and soft tissue sarcoma.
From injectable to oral formulation, from gynecological tumors to gastrointestinal tumors, from late-line to adjuvant treatment, and from China to global clinical trials, the company is steadily advancing the UTD2-related pipeline, hoping to bring more and better treatment options to patients.
Comments