{"entity":{"id":"nct03288987","kind":"trial","name":"Stivant (AryoGen bevacizumab) against Avastin in metastatic colorectal cancer","aka":["BE1040V phase 3","BEV.ARY.HR.94 (III)"],"tldr":"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.\n\nIn 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.","status":"completed","asOf":"2026-11-04","links":[{"label":"ClinicalTrials.gov NCT03288987","url":"https://clinicaltrials.gov/study/NCT03288987"},{"label":"Rezvani et al., 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":["biosimilar-manufacturing"],"targets":[],"drugs":["bevacizumab"],"companies":["aryogen-pharmed"],"institutions":[],"pathways":[],"terms":["biosimilar"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-be1040v-bevacizumab-biosimilar-clin-ther-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03288987","phase":"3","design":"non-inferiority","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.","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).","started":"2016-10-04","startedType":"actual","yearReported":2020,"enrolled":126,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct03288987/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"}],"technology":[{"id":"biosimilar-manufacturing","kind":"technology","name":"Biosimilar manufacturing and comparability","route":"/technologies/biosimilar-manufacturing/"}],"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/"}],"paper":[{"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","route":"/key-papers/paper-be1040v-bevacizumab-biosimilar-clin-ther-2020/"}]}}