{"entity":{"id":"paper-tjulandin-prolgolimab-miraculum-ejc-2021","kind":"paper","name":"MIRACULUM: prolgolimab, the first Russian-developed anti-PD-1 antibody, in advanced melanoma","aka":[],"tldr":"The trial behind Russia's own PD-1 antibody: 126 patients with advanced melanoma, an objective response in 38 per cent on the fortnightly dose and 29 per cent on the three-weekly dose, and severe treatment-related side effects in 13 and 3 per cent.","summary":"Prolgolimab is an IgG1 anti-PD-1 monoclonal antibody carrying the Fc-silencing LALA mutation, developed by Biocad in Saint Petersburg. MIRACULUM was a multicentre open-label parallel-arm phase 2 trial in which 126 patients with advanced cutaneous or non-cutaneous melanoma, including stable brain metastases, who had had no previous targeted, anti-PD-(L)1 or anti-CTLA-4 therapy, were randomised one to one to prolgolimab 1 mg/kg every two weeks or 3 mg/kg every three weeks until progression or intolerable toxicity.\n\nRecruitment ran from August 2017 to March 2018. At the one-year data cut-off, with median follow-up of 13.8 and 14.5 months, an objective response by independent central review was seen in 38.1 per cent of the fortnightly arm and 28.6 per cent of the three-weekly arm, and grade 3 to 4 treatment-related adverse events in 12.7 and 3.2 per cent. The trial is registered as NCT03269565.","asOf":"2026-09-25","links":[{"label":"Eur J Cancer 2021","url":"https://doi.org/10.1016/j.ejca.2021.02.030"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/33872982/"},{"label":"ClinicalTrials.gov NCT03269565","url":"https://clinicaltrials.gov/study/NCT03269565"}],"tags":[],"related":[],"cancers":["melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["bcd-100"],"companies":["biocad"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["european-journal-of-cancer"],"dependsOn":[],"notes":[],"journal":"European Journal of Cancer","year":2021,"doi":"10.1016/j.ejca.2021.02.030","pmid":"33872982","authors":"Tjulandin S, Demidov L, Moiseyenko V, et al.","paperType":"rct","findings":["Objective response 38.1 per cent with prolgolimab 1 mg/kg every two weeks and 28.6 per cent with 3 mg/kg every three weeks, by independent central review.","Grade 3 to 4 treatment-related adverse events 12.7 and 3.2 per cent respectively.","126 patients enrolled between August 2017 and March 2018, including patients with stable brain metastases."],"whatItMeans":"This is the evidence on which Russia licensed a PD-1 antibody of its own making, which matters because it is the reason immunotherapy remained available in Russian melanoma clinics on domestic supply. It is a single-country randomised phase 2 with no comparator against an established PD-1 antibody, so it does not establish equivalence with nivolumab or pembrolizumab.","caveats":["Phase 2, open label, with no active comparator: the two arms compare doses of the same drug, not prolgolimab against another PD-1 antibody.","All sites were in Russia and the sponsor is the manufacturer."],"participants":126},"route":"/key-papers/paper-tjulandin-prolgolimab-miraculum-ejc-2021/","neighbours":{"cancer":[{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"}],"drug":[{"id":"bcd-100","kind":"drug","name":"BCD-100","route":"/drugs/bcd-100/"}],"company":[{"id":"biocad","kind":"company","name":"Biocad","route":"/companies/biocad/"}],"journal":[{"id":"european-journal-of-cancer","kind":"journal","name":"European Journal of Cancer","route":"/journals/european-journal-of-cancer/"}]}}