Publicación de los datos finales del ensayo clínico de mAbxience de bevacizumab en cáncer colorrectal metastásico en The Lancet Gastroenterology & Hepatology

Monday, October 1, 2018

The prestigious scientific journal The Lancet Gastroenterology and Hepatology journal has published the results of the comparative study of pharmacokinetics, efficacy, safety and immunogenicity of bevacizumab biosimilar BEVZ92 in combination with FOLFOX or FOLFIRI, as the first-line treatment for metastatic colorectal cancer versus the original reference product. 

The trial included 15 sites from 5 countries, with a total of 142 randomised patients (71 patients per arm). The study’s main objective was to make a comparison between both molecules, the biosimilar medicinal product and its original reference, in terms of bioequivalence (AUC). The secondary objectives were to compare the efficacy (objective response, clinical benefit and progression-free survival), safety and immunogenicity.

The results conclude that BEVZ92 and the original reference medicinal product bevacizumab are pharmacokinetically equivalent and have no significant differences in their efficacy and safety profiles in combination with FOLFOX or FOLFIRI in the first-line treatment of metastatic colorectal cancer. Regarding immunogenicity, the appearance of anti-drug antibodies (ADA) was low and similar in both treatment groups.

This publication provides further support for the clinical demonstration of biosimilarity of our bevacizumab and underscores the quality of mAbxience's trials and biosimilars.