{"entity":{"id":"paper-be1040v-bevacizumab-biosimilar-clin-ther-2020","kind":"paper","name":"Efficacy and safety of proposed bevacizumab biosimilar BE1040V in patients with metastatic colorectal cancer: a phase III, randomized, double-blind, noninferiority clinical trial","aka":[],"tldr":"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.","asOf":"2026-11-04","links":[{"label":"Clin Ther 2020","url":"https://doi.org/10.1016/j.clinthera.2020.03.009"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/32334845/"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":[],"drugs":["bevacizumab"],"companies":["aryogen-pharmed"],"institutions":[],"pathways":[],"terms":["biosimilar"],"trials":["nct03288987"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"journal":"Clinical Therapeutics","year":2020,"doi":"10.1016/j.clinthera.2020.03.009","pmid":"32334845","authors":"Rezvani H, Mortazavizadeh SM, Allahyari A, et al.","paperType":"rct","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."],"whatItMeans":"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."],"participants":126},"route":"/key-papers/paper-be1040v-bevacizumab-biosimilar-clin-ther-2020/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"}],"drug":[{"id":"bevacizumab","kind":"drug","name":"Bevacizumab","route":"/drugs/bevacizumab/"}],"company":[{"id":"aryogen-pharmed","kind":"company","name":"AryoGen Pharmed","route":"/companies/aryogen-pharmed/"}],"term":[{"id":"biosimilar","kind":"term","name":"Biosimilar","route":"/terms/biosimilar/"}],"trial":[{"id":"nct03288987","kind":"trial","name":"Stivant (AryoGen bevacizumab) against Avastin in metastatic colorectal cancer","route":"/trials/nct03288987/"}]}}