Eye on Pharma: Phase 3 Trial of Bio-Thera Solutions' BAT1706 Yields Positive Results

Bio-Thera Solutions announced that a phase 3 clinical trial comparing the efficacy and safety of its bevacizumab biosimilar, BAT1706, to the reference product (Avastin) returned positive top-line results.

The Chinese commercial-stage biopharmaceutical company said in a press release that BAT1706 proved equivalent to bevacizumab in overall response rate as a first-line treatment for non-squamous non-small cell lung cancer.

“We are pleased to report on our second proposed biosimilar with positive study results,” said Shenfeng Li, PhD, the chief executive officer of Bio-Thera Solutions. “These results demonstrate the potential of our proposed bevacizumab biosimilar to be a safe and effective treatment option for cancer patients. Bio-Thera is committed to increasing patient access to innovative medicines through the development of high-quality biosimilars.”

Avastin is indicated in the US to treat metastatic colorectal cancer, non-squamous non-small cell lung cancer, persistent, recurrent, or metastatic cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer, along with other conditions.

According to the press release, “BAT1706 works by binding the vascular endothelial growth factor (VEGF) protein.” It has not yet received regulatory approval in any country.

The trial consisted of a multicenter, randomized, double-blind study which evaluated the pharmacokinetics and immunogenicity of BAT1706. Results of the study have yet to be released and the company is developing several other proposed biosimilars including ustekinumab, secukinumab and golimumab.

Separately this week, the FDA requested data for Formycon’s Lucentis biosimilar candidate FYB201, as part of a review process for a biologics license application (BLA). The company stated it will take around 4 months to generate the additional data. However, Bioeq, its licensing partner, announced it would withdraw its BLA for the biosimilar candidate, provide requested data, and resubmit the application after, which may delay approval of the BLA.