Date: 2014-10-21
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
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 October 21, 2014, a Phase 3 trial sponsored by Boehringer Ingelheim was published on the NIH website ClinicalTrials.gov for BI 695502 and is currently recruiting participants.
