ABP 215 is an engineered monoclonal antibody being developed by Amgen in collaboration with Allergan. ABP 215 binds to vascular endothelial growth factor A (VEGF A), a cellular protein that promotes the growth of blood vessels.
It is a biosimilar candidate to Avastin (bevacizumab), which is approved for the treatment of multiple cancers, including non-squamous non-small cell lung cancer (NSCLC). (Biosimilar refers to a biological product similar in its active properties (safety and effectiveness) to an already approved product.)
How ABP 215 works
It works in the same way as Avastin, which also is an engineered monoclonal antibody that binds specifically to VEGF. This binding blocks the interaction between VEGF and its receptors — VEGFR 1 and VEGFR 2 — eventually inhibiting the growth of new blood vessels that provide oxygen and nutrients to the tumors. Thus, ABP 215, like Avastin, works by starving the tumors and killing them.
ABP 215 in clinical trials
A randomized, double-blind Phase 3 study (NCT01966003) evaluated the safety and effectiveness of ABP 215 in comparison to Avastin in 642 patients with advanced NSCLC who were receiving chemotherapy with carboplatin and Taxol (paclitaxel). Both ABP 215 and Avastin were given at a dose of 15 mg/kg injected into the bloodstream for up to six cycles.
The results showed that ABP 215 is clinically equivalent to Avastin, with no differences in terms of effectiveness, safety, or the ability to elicit an immune response (immunogenicity).
Other information
The two companies (Amgen and Allergan) submitted a biologics license application (BLA) for ABP 215 to the U.S. Food and Drug Administration (FDA) in November 2016. On July 13, 2017, the companies met with an FDA advisory committee to discuss and reviewed the data supporting the BLA for ABP 215. Analytical, pharmacokinetic, and clinical data validating the similarity between ABP 215 and Avastin were presented at the meeting.
The companies also submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) in December 2016.
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