Bio-Thera Solutions, announced the initiation of a Phase III clinical trial evaluating the efficacy and safety of its investigational HER2 Antibody-Drug Conjugate (ADC), BAT8001, in patients with HER-2 positive metastatic breast cancer who previously received trastuzumab separately or in combination with taxanes. The trial is designed to compare BAT8001 versus lapatinib combined with capecitabine which is 2nd-line standard of care for metastatic breast cancer patients in China.
This Phase III, multicenter, randomized, open-label, controlled trial will recruit approximately 410 patients in China. The primary efficacy outcome of the trial is progression-free survival (PFS). Other pre-specified outcome measures include overall survival (OS), and objective response rate (ORR). The safety and immunogenicity of BAT8001 will also be evaluated in the trial.
BAT8001 is an investigational HER2-ADC being evaluated in multiple tumor types. HER2 is a naturally occurring receptor that is overexpressed in many types of cancer, including breast cancer and gastric cancer. BAT8001 is being developed for use as a single agent and in combination with other agents for the treatment of multiple cancers. The BAT8001 clinical study program will be expanded beyond metastatic cancer to other HER2-positive cancers, including gastric cancer, over the next 12 months.
The company recently announced that the China National Drug Administration had accepted its BLA for a Humira biosimilar for review. Bio-Thera has announced its intention to introduce the Humira biosimilar in the US eventually. The company is also developing a biosimilar to Actemra.