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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.
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.
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.
Shares BCD-100, Biocad, European Journal of Cancer.