# Stivant (AryoGen bevacizumab) against Avastin in metastatic colorectal cancer

Source: https://onco.cc/trials/nct03288987/  
OnCo record `nct03288987` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

An Iranian phase 3 trial that found a locally made copy of bevacizumab worked as well as the original in bowel cancer that had spread.

## Summary

AryoGen Pharmed's trial randomised patients with metastatic colorectal cancer 2:1 to its bevacizumab (5 mg/kg, called BE1040V in the paper and Stivant on ClinicalTrials.gov) or the originator Avastin, each with FOLFIRI-3 chemotherapy every two weeks for a year. ClinicalTrials.gov lists 22 sites, all in Iran, in Tehran, Mashhad, Isfahan, Shiraz, Rasht, Kermanshah, Ahvaz, Hamadan and Yazd; the trial ran from October 2016 to July 2018 and enrolled 126 patients.

In the 2020 report in Clinical Therapeutics, progression-free survival was 232 days (7.7 months) with the biosimilar and 210 days (7 months) with the reference product; the hazard ratio was 0.79 (90% CI 0.46 to 1.35), whose upper limit was under the non-inferiority margin of 1.44. Overall survival, response rate and safety did not differ significantly.

## Fields

- Kind: Trial
- Status: completed
- Last checked: 2026-11-04
- Also known as: BE1040V phase 3; BEV.ARY.HR.94 (III)
- Registry id: NCT03288987
- Phase: 3
- Setting: Phase 3, randomised, blinded, non-inferiority trial of a proposed bevacizumab biosimilar against the originator, each with FOLFIRI-3, in metastatic colorectal cancer
- Sponsor: AryoGen Pharmed Co.
- Enrolled: 126
- Result: Non-inferior: progression-free survival 7.7 months against 7.0 months, hazard ratio 0.79 (90% CI 0.46 to 1.35), margin 1.44 (Clin Ther 2020).

## Sources

- ClinicalTrials.gov NCT03288987: https://clinicaltrials.gov/study/NCT03288987
- Rezvani et al., 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/)
- technologies: [Biosimilar manufacturing and comparability](https://onco.cc/technologies/biosimilar-manufacturing/)
- drugs: [Bevacizumab](https://onco.cc/drugs/bevacizumab/)
- companies: [AryoGen Pharmed](https://onco.cc/companies/aryogen-pharmed/)
- terms: [Biosimilar](https://onco.cc/terms/biosimilar/)
- key papers: [Efficacy and safety of proposed bevacizumab biosimilar BE1040V in patients with metastatic colorectal cancer: a phase III, randomized, double-blind, noninferiority clinical trial](https://onco.cc/key-papers/paper-be1040v-bevacizumab-biosimilar-clin-ther-2020/)

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