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

Author:

Bekaii-Saab Tanios S1ORCID,Balser Sigrid2,Lohmann Ragna3,Daoud Hasan3,Liedert Bernd4,Schliephake Dorothee3

Affiliation:

1. Mayo Clinic Cancer Center, Department of Internal Medicine, Mayo Clinic Hospital, 5777E. Mayo Blvd, Phoenix, AZ 85054, USA

2. Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88400 Biberach an der Riss, Germany

3. Boehringer Ingelheim International GmbH, Binger Str. 173, 55218 Ingelheim am Rhein, Germany

4. (Formerly at) Boehringer Ingelheim International GmbH, Binger Str. 173, 55218 Ingelheim am Rhein, Germany

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

Funder

Boehringer Ingelheim Pharmaceuticals, Inc.

Publisher

Future Medicine Ltd

Subject

Process Chemistry and Technology,Economic Geology,Fuel Technology

Reference34 articles.

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4. Bevacizumab in Colorectal Cancer: Current Role in Treatment and the Potential of Biosimilars

5. Genentech Inc. Avastin® Prescribing Information (2020). https://www.gene.com/download/pdf/avastin_prescribing.pdf (Accessed August 2022).

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