BI 695502 Demonstrates Bioequivalence to Bevacizumab in Healthy Individuals
The bevacizumab biosimilar candidate BI 695502 demonstrated bioequivalence to bevacizumab (Avastin) in a phase 1 study.
BI 695502, a bevacizumab biosimilar candidate developed by Boehringer Ingelheim, is bioequivalent to bevacizumab (Avastin), an angiogenesis inhibitor approved for a variety of cancer types, according to findings from a phase 1 study of healthy individuals.1
Investigators evaluated the bioequivalence of the 2 agents in the INVICTAN-1 trial (ClinicalTrials.gov Identifier: (NCT01608087), which enrolled 91 healthy male individuals who were randomly assigned to receive bevacizumab or its biosimilar candidate.
Results showed that BI 695502 was well-tolerated, and researchers did not observe any clinically relevant differences in safety or immunogenicity between the 2 treatment arms.
Because BI 695502 met all pre-defined primary and secondary end points in this study, investigators will continue evaluating the efficacy of safety of BI 695502 in combination with chemotherapy compared with bevacizumab plus chemotherapy in patients with advanced non-squamous non-small cell lung cancer in the double-blind, phase 3 INVICTAN-2 study (NCT02272413).
Researchers plan to enroll approximately 660 patients. The primary endpoint is best overall response rate, with progression-free survival, overall survival, and safety as secondary outcome measures. Investigators expect to complete data collection for the primary endpoint in August 2017.
- Boehringer Ingelheim bevacizumab biosimilar candidate demonstrates bioequivalence to Avastin. Boehringer Ingelheim website. http://us.boehringer-ingelheim.com/news_events/press_releases/press_release_archive/2016/11-16-2016-boehringer-ingelheim-bevacizumab-biosimilar-candidate-demonstrates-bioequivalence-avastin.html. Updated November 16, 2016.