The Institute of Personalized Oncology at Sechenov First Moscow State Medical University, under the Ministry of Health of the Russian Federation, has advanced the final stage of a clinical trial evaluating a pembrolizumab biosimilar for advanced melanoma. The work, which reflects ongoing import substitution efforts, is described as a major milestone in Russia’s cancer treatment program by researchers from Sechenov University.
Developed by the R-Pharm group, the Russian product is a bioanalogue of an American immuno-oncology drug that has established use in the treatment of late-stage melanoma, as well as certain lung and gynecologic cancers. The biosimilar’s progress is framed as a national effort to provide accessible, effective therapy options for patients with limited alternatives, while aligning with global standards of care.
The initial two stages of the trial were conducted at Sechenov University. Those early phases demonstrated favorable tolerability and safety profiles for the investigational biosimilar, which encouraged investigators to proceed to the pivotal final stage. The progression to this stage signals confidence in the drug’s potential to meet regulatory expectations and clinical needs.
The third stage aims to confirm the product’s effectiveness in a real-world patient population. Approximately 300 participants are planned for enrollment and will be randomly assigned to two arms: one receiving the Russian biosimilar and the other receiving the reference American product. The treatment period for melanoma patients is designed to extend for two years, with preliminary effectiveness data anticipated about six months after patient enrollment begins. These timelines reflect typical patterns in oncology trials where early signals can guide further optimization of therapy.
Oncologic experts emphasize that tumors often deploy mechanisms to dodge immune detection. Immunotherapy drugs work by reactivating the immune system so it can recognize and attack cancer cells. In the context of melanoma, such therapies have shown meaningful activity in a subset of patients with advanced disease, enabling durable responses that were historically hard to achieve. As described by Marina Sekacheva, director of the Institute of Personalized Oncology at Sechenov University, the current approach holds promise for extending survival and improving quality of life for patients who have limited treatment options. The discussion highlights the ongoing effort to translate clinical trial insights into broader access to effective immunotherapies within Russia and beyond. [Citation: Sechenov University team briefing]
The landscape for melanoma treatment continues to evolve with international collaboration and ongoing evaluation of biosimilar options. The trial underlines a strategic commitment to bringing innovative, evidence-based therapies to patients while ensuring rigorous safety monitoring, robust data collection, and transparent reporting of outcomes. In the global context, researchers monitor parallel developments in North America and Europe to compare real-world effectiveness, safety signals, and patient-reported outcomes, strengthening the overall evidence base for pembrolizumab-like therapies.
Because the strategies for immunotherapy are continually refined, investigators and clinicians advocate continuous observation of adverse effects, treatment response rates, and long-term survival trends. The ultimate goal is to provide melanoma patients with reliable, affordable treatment options that can be integrated into standard care pathways, whether in major metropolitan centers or regional healthcare facilities. As this trial progresses, the medical community will assess how closely the Russian biosimilar aligns with its American counterpart in terms of efficacy, safety profile, dosing paradigms, and accessibility for patients across different healthcare systems. [Citation: Sechenov Institute communications]