# MIRACULUM: prolgolimab, the first Russian-developed anti-PD-1 antibody, in advanced melanoma

Source: https://onco.cc/key-papers/paper-tjulandin-prolgolimab-miraculum-ejc-2021/  
OnCo record `paper-tjulandin-prolgolimab-miraculum-ejc-2021` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

Recruitment 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.

## Fields

- Kind: Key paper
- Last checked: 2026-09-25
- Journal: European Journal of Cancer
- Year: 2021
- DOI: 10.1016/j.ejca.2021.02.030
- Authors: Tjulandin S, Demidov L, Moiseyenko V, et al.
- 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.
- What it means: 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.

## Sources

- Eur J Cancer 2021: https://doi.org/10.1016/j.ejca.2021.02.030
- PubMed: https://pubmed.ncbi.nlm.nih.gov/33872982/
- ClinicalTrials.gov NCT03269565: https://clinicaltrials.gov/study/NCT03269565

## Connected records

- cancers: [Melanoma](https://onco.cc/cancers/melanoma/)
- drugs: [BCD-100](https://onco.cc/drugs/bcd-100/)
- companies: [Biocad](https://onco.cc/companies/biocad/)
- journals: [European Journal of Cancer](https://onco.cc/journals/european-journal-of-cancer/)

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