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Posted by on May 17, 2020 in Colorectal cancer | 0 comments

In a nutshell

This study compared the effectiveness and safety of bevacizumab biosimilar (BE1040V) to the reference drug (Avastin) in the treatment of patients with metastatic colorectal cancer (mCRC). Researchers suggested that the effectiveness and safety of the biosimilar were similar to the reference drug bevacizumab.

Some background

Colorectal cancer (CRC) is a common cancer that affects between 4.1 and 4.4% of the US population. A significant number of patients have metastatic (spread to other parts of the body) cancer (mCRC). In these cases, chemotherapy has only limited effects. Therefore, the addition of other drugs might improve the treatment response.

Bevacizumab is a biologic therapy that targets cancer cells to stop them from growing. This drug is recommended as first and/or second-line therapy for patients with mCRC. Biosimilar drugs are drugs very similar to reference products. They increase the access of patients to biologic therapy, by making it more affordable. It also decreases the financial burden of health care systems and professionals.

It is not clear yet if the effectiveness and safety of the biosimilar BE1040V are comparable to its reference product bevacizumab.

Methods & findings

This study included information about 126 patients with mCRC. All patients were assigned to receive FOLFIRI-3 (5-fluorouracil, folinic acid, and irinotecan on day 1 and repeated on day 3) chemotherapy. In addition, patients were randomly assigned to receive either bevacizumab (group 1) or its biosimilar (group 2) every 2 weeks for 1 year.

Progression-free survival (PFS; time from treatment to progression) was 7.7 months in group 2 and 7 months in group 1. Patients from group 2 had a 21% improvement in the odds of a better PFS. There was no difference in overall survival between groups.

The overall response rate was slightly higher in group 2 (40.48%) than in group 1 (21.74%). No significant differences were seen in side effects between both groups.

The bottom line

This study concluded that bevacizumab biosimilar effectiveness and safety is similar to its reference drug in patients with mCRC.

The fine print

This study was funded by AryoGen Pharmed Company, the manufacturer of BE1040V.

Published By :

Clinical therapeutics

Date :

Apr 22, 2020

Original Title :

Efficacy and safety of proposed bevacizumab biosimilar BE1040V in patients with metastatic colorectal cancer: A phase III, randomized, double-blind, noninferiority clinical trial.

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