In the evening of June 21, 2021, leading Russian and international cancer experts presented the results of a three-year efficacy study of the Russian original immuno-oncology product prolgolimab (BIOCAD) in patients with metastatic melanoma during a satellite symposium at the 7th St. Petersburg «White Nights» International Oncology Forum.

The MIRACULUM study included 126 patients over 18 years of age with unresectable or metastatic melanoma from Russia and the Republic of Belarus.

The study achieved the primary endpoint in both prolgolimab treatment arms, at 1 mg/kg every 2 weeks and 3 mg/kg every 3 weeks. The median follow-up period was 39.6 months (95% CI: [38.9; 41.5]). The 3-year overall survival (OS) in patients with metastatic melanoma treated with 1 mg/kg of prolgolimab every 2 weeks was 43.1%, and the median OS was 26.1 months (95% CI; 18.3 – not reached). The OS of patients with metastatic skin melanoma treated with prolgolimab as a first-line therapy was 55%, while the median OS was not reached (95% CI; 23.2 – not reached).

Subgroup analysis showed that OS in patients with BRAF mutation was 46.7% and the median OS was 14.7 months (95% CI: 7.0 – not reached). In patients without BRAF mutation, the OS was 69.6% and the median OS was not reached. In patients with central nervous system (CNS) metastases, the OS was 40% with a median OS of 19.6 months (95% CI: 7.1 – not reached). In patients without CNS metastases the OS was 60.2% and the median OS was not reached (95% CI: 27.6 – not reached).

The assessment of the drug safety profile did not reveal any new adverse events which had not been observed in other drugs of this class. The adverse events were most likely to manifest within 6 months after treatment initiation. The dosage regimen of 1 mg/kg once every 2 weeks was approved for clinical use based on the results of the MIRACULUM study.

Alexander M.M. Eggermont, Professor of Clinical and Translational Immunotherapy of Utrecht University Medical Center, Editor-in-chief of the European Journal of Cancer, gave a very positive assessment of the results of the 3-year follow-up in the MIRACULUM study and called the results very promising and demonstrating a slightly superior efficacy of the drug compared to similar PD-1 molecules.

Professor Eggermont added that the study promising results over a long-term follow-up period:

Now we see the data on three years of follow-up, and there is a steady pronounced response. We can see that the results of one, two and three years of follow-up are absolutely equivalent.

On April 17, 2021, an article presenting the results of the MIRACULUM clinical study was published in the European Journal of Cancer, demonstrating the high quality and relevance of the study results.

Prolgolimab is an anti-PD-1 monoclonal antibody designed to restore the anti-tumor activity of the human body’s immune response.

In contrast to other drugs of this class registered in the Russian Federation, this Russian drug was developed on the basis of another immunoglobulin G1 isotype using an Fc fragment that had been modified via genetic engineering.

Every day, even in a healthy person, malignant cells are produced and destroyed by the immune mechanisms before the tumor becomes large enough to pose a threat to the person’s health. A cancer cell can evade the immune response by disguising itself as a normal cell, which leads to tumor growth and the inability of the immune system to resist the development of malignancies.

PD-1 inhibitors activate T-cells and allow them to recognize and destroy malignant cells so that the immune system can restore its ability to fight the tumor growth.

Cancer immunotherapy is one of the most promising directions of medical science worldwide. More than 1 500 studies of new immune checkpoint inhibitors are carried out annually.

The growth of the global PD-1 inhibitor market is measured in double digits, at the end of 2020 it amounted to more than $22 billion.

To date, BIOCAD’s investments in this project have exceeded 737 million rubles (more than $10 million). Russian research and development in the field of cancer immunotherapy can make a significant contribution to international science and practice.