Date: 2016-11-16
Type of information: update on patient enrollment
phase: 3
Announcement: update
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: non-small cell lung cancer (NSCLC)
Therapeutic area: Cancer - Oncology
Country: Argentina, Brazil, Bulgaria, Chile, Croatia, Egypt, El Salvador, Germany, Greece, Hungary, Italy, Japan, Republic of Korea, Malaysia, Mexico, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, South Africa, Spain, Thailand, Turkey, Ukraine, UK, USA, Vietnam, India, Indonesia
Trial
details: The objective of this phase III trial is to establish statistical equivalence in terms of efficacy (best overall response rate [ORR], proportion of patients with complete response [CR] plus partial response [PR]) until 18 weeks of first-line treatment with BI 695502 plus chemotherapy versus Avastin® plus chemotherapy followed by maintenance monotherapy with either BI 695502 or Avastin®. ( NCT02272413)
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 (link is external) at the American Association of Pharmaceutical Scientists Annual Meeting in Denver, CO, November 13 – 17. The company is currently looking forward to the completion of the ongoing pivotal Phase III trial in lung cancer.
