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Abstract

Bevacizumab biosimilar for metastatic colorectal cancer successfully tried in Iranian phase III study

Article title: Efficacy and Safety of Proposed Bevacizumab Biosimilar BE1040V in Patients With Metastatic Colorectal Cancer: A Phase III, Randomized, Double-blind, Noninferiority Clinical Trial

Citation: Rezvani H et al. Clin Ther 2020;42:848–59

Publication date: April 2020

Although screening programs exist, most patients with colorectal cancer (CRC) are diagnosed after onset of symptoms and have advanced disease. Biologic medicines are vital for the treatment of serious conditions such as CRC – but at a high financial burden. BE1040V is a bevacizumab biosimilar developed with the aim of increasing access to treatment and reducing mortality due to CRC.

Metastatic colorectal cancer (mCRC) is the second-highest cause of cancer death worldwide with a 5-year survival rate around 14%. In unresectable cases, first-line systemic therapy may be an option – which includes combination chemotherapy plus biologics targeted against vascular endothelial growth factor (VEGF) (e.g., bevacizumab). This phase III randomised study conducted in 22 centres in Iran aimed to evaluate the efficacy, safety, and immunogenicity of BE1040V, a bevacizumab biosimilar, versus its reference product in patients with mCRC.

Findings

Following treatment with BE1040V or bevacizumab, the primary endpoint of progression-free survival (PFS) was 7.7 months and 7 months, respectively, suggesting noninferiority between BE1040V and bevacizumab. No significant intergroup differences were detected for adverse events nor for any secondary endpoints including overall survival (OS), objective response rate (ORR), and time to treatment failure (TTF). Anti-drug antibodies developed in only two patients (one per treatment group).

No statistically meaningful differences were found between BE1040V and reference bevacizumab in terms of PFS, OS, ORR, TTF, safety, and immunogenicity. The trialists concluded BE1040V has noninferior efficacy and comparable tolerability to reference bevacizumab in patients with mCRC.

Key takeaway

The bevacizumab biosimilar BE1040V was found to have no meaningful differences in safety and efficacy to the originator in a multi-centre, randomised, study conducted in metastatic colorectal cancer patients.

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