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

Source: https://onco.cc/key-papers/paper-be1040v-bevacizumab-biosimilar-clin-ther-2020/  
OnCo record `paper-be1040v-bevacizumab-biosimilar-clin-ther-2020` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial at Iranian hospitals found that a locally made copy of bevacizumab controlled metastatic bowel cancer as well as the original.

## Summary

126 patients with histologically verified colorectal cancer and at least one metastasis were randomised 2:1 to 5 mg/kg of the proposed biosimilar or the reference bevacizumab, each with FOLFIRI-3 every two weeks for one year. Progression-free survival was the primary endpoint, assessed per protocol with a non-inferiority margin of 1.44 for the hazard ratio.

## Fields

- Kind: Key paper
- Last checked: 2026-11-04
- Journal: Clinical Therapeutics
- Year: 2020
- DOI: 10.1016/j.clinthera.2020.03.009
- Authors: Rezvani H, Mortazavizadeh SM, Allahyari A, et al.
- Findings: Progression-free survival was 232 days (7.7 months) with the biosimilar and 210 days (7 months) with the reference (P = 0.47).; Hazard ratio 0.79 (90% CI 0.46 to 1.35), upper limit below the 1.44 margin: non-inferior.; Overall survival hazard ratio 0.99 (95% CI 0.55 to 1.80); safety comparable; one patient in each arm had anti-drug antibodies.
- What it means: Evidence that the bevacizumab made in Iran by AryoGen performs like the original, which matters in a country where imported originals have been hard to obtain.
- Caveats: A small trial with a wide confidence interval and a 2:1 allocation.; Industry-sponsored; the paper names the product BE1040V and the registry Stivant.

## Sources

- Clin Ther 2020: https://doi.org/10.1016/j.clinthera.2020.03.009
- PubMed: https://pubmed.ncbi.nlm.nih.gov/32334845/

## Connected records

- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/)
- drugs: [Bevacizumab](https://onco.cc/drugs/bevacizumab/)
- companies: [AryoGen Pharmed](https://onco.cc/companies/aryogen-pharmed/)
- terms: [Biosimilar](https://onco.cc/terms/biosimilar/)
- trials: [Stivant (AryoGen bevacizumab) against Avastin in metastatic colorectal cancer](https://onco.cc/trials/nct03288987/)

---
JSON: https://onco.cc/api/v1/entities/paper-be1040v-bevacizumab-biosimilar-clin-ther-2020.json