Phase IIIb study of the bevacizumab biosimilar candidate BI 695502 plus mFOLFOX6 in metastatic colorectal cancer
Colorectal Cancer, our partnered journal, has recently published a Short Communication article exploring the safety and efficacy of BI 695502 combined with mFOLFOX6 as first-line therapy in patients with metastatic colorectal cancer.
Abstract
Aim: 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). Materials & methods: 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). Results: 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. Conclusion: BI 695502 has an acceptable safety and efficacy profile in the treatment of mCRC.
Trial Registration Number:NCT02776683 (ClinicalTrials.gov), 2015-003718-25 (EudraCT, European Clinical Trials Database https://www.clinicaltrialsregister.eu/ctr-search/search?query=2015-003718-25)
Study name: Study 1302.3