Phase IIIb study of the bevacizumab biosimilar candidate BI 695502 plus mFOLFOX6 in metastatic colorectal cancer

This study assessed the safety, efficacy, pharmacokinetics and immunogenicity of the bevacizumab biosimilar candidate BI 695502 plus mFOLFOX6 in patients with metastatic colorectal cancer (mCRC). Patients with untreated mCRC received BI 695502 and chemotherapy (oxaliplatin, leucovorin and 5-fluorouracil). Primary end point: proportion of patients with prespecified adverse events (AEs). Of 123 patients enrolled and treated, 58.5% experienced prespecified AEs. Median progression-free survival was 10.5 months, median overall survival was 19.4 months, and objective response rate was 61.0%. There were no antidrug antibody or neutralizing antidrug antibody-positive samples post-baseline. Trough BI 695502 plasma concentrations increased until cycle 9 and stabilized thereafter. BI 695502 has an acceptable safety and efficacy profile in the treatment of mCRC. ( ), 2015-003718-25 (EudraCT, European Clinical Trials Database ) Study 1302.3