On February 3, 2020 Bio-Thera Solutions, a commercial-stage biopharmaceutical company, reported that the Phase III clinical trial comparing the safety and efficacy of BAT1706 versus Avastin1 (bevacizumab) met its primary endpoint (Press release, BioThera Solutions, FEB 3, 2020, View Source [SID1234553770]). BAT1706 is being developed by Bio-Thera Solutions as a proposed biosimilar to Avastin. The trial demonstrated equivalence in overall response rate (ORR) for the first-line treatment of patients with non-squamous non-small cell lung cancer.
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"We are pleased to report on our second proposed biosimilar with positive study results. These results demonstrate the potential of our proposed bevacizumab biosimilar to be a safe and effective treatment option for cancer patients," said Shengfeng Li, Ph.D., CEO of Bio-Thera Solutions. "Bio-Thera is committed to increasing patient access to innovative medicines through the development of high-quality biosimilars."
The BAT1706 Phase III clinical study is a multicenter, randomized, double blind, study evaluating the efficacy, safety, pharmacokinetics and immunogenicity of BAT1706 versus EU Avastin plus chemotherapy in patients with advanced non squamous non-small cell lung cancer. The primary endpoint measures ORR. Results of the study will be presented in full at a future medical meeting or summarized in publication.
More information regarding the BAT1706 Phase III clinical trial, including inclusion and exclusion criteria and primary and secondary outcome measures, can be found here: View Source
BAT1706 is Bio-Thera Solutions’ second proposed biosimilar with positive Phase III study results. The company’s first biosimilar product, QLETLI (格乐立), a biosimilar to Humira (adalimumab), has received marketing authorization and is available in China. Bio-Thera Solutions is developing several additional proposed biosimilars, including ustekinumab, secukinumab and golimumab, among others.
About BAT1706
BAT1706 is a monoclonal antibody (mAb) that is in development as a potential biosimilar to Avastin. BAT1706 works by binding the vascular endothelial growth factor (VEGF) protein. In the U.S., Avastin is indicated for the treatment of patients with metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, persistent, recurrent, or metastatic cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer. BAT1706 is an investigational compound and has not received regulatory approval in any country. Biosimilarity has not yet been established by regulatory authorities.