As part of the XXVIII Russian Oncology Congress, hosted by the Russian Society of Clinical Oncology in collaboration with the Blokhin National Medical Research Center of Oncology and the Association of Oncologists of Russia, a symposium focused on “Arfleyda” was held. This innovative drug, a biosimilar to pembrolizumab, was developed by the dedicated teams at the R-Pharm group of companies.
During the symposium, Igor Samoylenko, a senior researcher at the Blokhin National Medical Research Center of Oncology under the Russian Ministry of Health, unveiled for the first time the findings from a phase III clinical trial of a groundbreaking drug. This groundbreaking study encompassed more than 250 adult patients diagnosed with skin melanoma. They were randomly divided into two groups: one group received the original pembrolizumab, the second – the drug “Arfleyda”. The results showed that the drug “Arfleyda” is no less effective and safe than the original drug.
Thus, the objective response rate was 28.35% in the Arfleyda group and 24.56% in the original drug group. At the same time, to test the non-inferiority hypothesis, a 95% confidence interval for the relative risk indicator was calculated. The confidence interval’s lower limit was 0.755, exceeding the hypothesis threshold of 0.644.
The experts also discussed the process of developing a biosimilar, from in vitro tests to animal studies. The equivalence of the R-Pharm group drug to pembrolizumab was confirmed at each stage.