Date: 2016-11-16
Type of information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the American Association of Pharmaceutical Scientists Annual Meeting
Company: Boehringer Ingelheim (Germany)
Product: BI 695502 (biosimilar version of bevacizumab - Avastin®)
Action
mechanism: monoclonal antibody/biosimilar. Bevacizumab is a humanized antibody to vascular endothelial growth factor (VEGF). It binds VEGF and prevents the interaction of VEGF to its receptors on the surface of endothelial cells. The interaction of VEGF with its receptors leads to endothelial cell proliferation and new blood vessel formation.
Disease:
Therapeutic area: Cancer - Oncology
Country: New Zealand
Trial
details: INVICTAN-1 is a randomized, blinded, single-dose, parallel-arm Phase I clinical study, evaluating bioequivalence (how a drug is absorbed, distributed, metabolized and excreted in the body) of BI 695502 to Avastin®. The study enrolled 91 healthy male individuals who were randomized evenly across treatment groups. (NCT01608087 )
Latest
news: * On November 16, 2016, Boehringer Ingelheim announced new data from the Phase I INVICTAN®-1 study, which show that BI 695502, its bevacizumab biosimilar candidate, is bioequivalent to U.S.-licensed and –EU approved Avastin®. BI 695502 met all the pre-defined primary and secondary endpoints in the INVICTAN®-1 study. These data were presented in a poster at the American Association of Pharmaceutical Scientists Annual Meeting in Denver, CO, November 13 – 17. The study enrolled 91 healthy male individuals who were randomized evenly across treatment groups. BI 695502 was well-tolerated in this study, with no clinically relevant differences in safety or immunogenicity evaluations between the BI 695502 and bevacizumab treatment groups.
