The first Russian original PD-1 inhibitor Forteca® (prolgolimab) was granted approval for market authorization by the Russian Ministry of Health for the treatment of one of the most aggressive types of cancer – unresectable or metastatic melanoma. The approval is based on the positive clinical results from a multicenter open-label parallel-arm phase II study MIRACULUM (NCT03269565) in patients with advanced melanoma.
During the study, patients received prolgolimab 1 mg/kg every two weeks or 3 mg/kg every 3 weeks until disease progression or intolerable toxicity. Both dosing regimens of prolgolimab showed significant antitumor activity and manageable safety profile in patients with advanced melanoma. Objective response was achieved in 42 out of 126 patients (33.3%), who received prolgolimab monotherapy. 12-mo overall survival rates were 74.6% for 1 mg/kg every 2 weeks group and 54.0% for 3 mg/kg every 3 weeks group.
Prolgolimab is the first immunoglobulin G1 anti-PD-1 monoclonal antibody with Fc silencing “LALA” mutation. The mechanism of action of PD-1 inhibitors is aimed at restoring the ability of T-lymphocytes to recognize and destroy malignant cells, and as a result the immune system restarts fighting the tumor. Immunotherapy is one of the most promising areas of global medicine. Over 3000 clinical studies of immune checkpoint inhibitors are being conducted in more than 20 types of tumors. The global market for immunotherapeutic drugs in 2019 is valued at $22 billion.
Prolgolimab is also being investigated for other types of cancers in Russia and Europe. BIOCAD is already recruiting the patients for European Phase IIII clinical study in advanced NSCLC and has received multiple authorizations across Europe to conduct the Phase III study in advanced Cervical Cancer.