5 February 2020 - - A Phase III clinical trial comparing the safety and efficacy of BAT1706 versus Avastin1 (bevacizumab) met its primary endpoint, China-based commercial-stage biopharmaceutical company Bio-Thera Solutions said.

BAT1706 is being developed by Bio-Thera Solutions as a proposed biosimilar to Avastin.

The trial demonstrated equivalence in overall response rate for the first-line treatment of patients with non-squamous non-small cell lung cancer.

The BAT1706 Phase III clinical study is a multicenter, randomised, 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.

BAT1706 is Bio-Thera Solutions' second proposed biosimilar with positive Phase III study results.

The company's first biosimilar product, QLETLI, 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.

BAT1706 is a monoclonal antibody that is in development as a potential biosimilar to Avastin. BAT1706 works by binding the vascular endothelial growth factor protein.

In the US, 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.

Bio-Thera Solutions, Ltd., a leading commercial-stage biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases.

As a specialty in the next generation antibody discovery and engineering, the company has advanced five candidates into late stage clinical trials and one of which, QLETLI, a biosimilar to Humira (adalimumab), is available to patients with rheumatoid arthritis, ankylosing spondylitis, or plaque psoriasis in China.

In addition, the company has multiple candidates in early clinical trials and IND-enabling studies, focusing on innovative targets in immuno-oncology and autoimmune diseases.