Novel anti-PD-1 drug was approved for melanoma treatment

The first Russian original PD-1 inhibitor Forteca® (INN: 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. Treatment-related AEs (TRAEs) occurred in 55.6% and 54.0% of pts, including 12.7% and 3.2% with grade 3-4 TRAEs in arm 1 and 2, respectively [1].

Melanoma is a type of skin cancer that develops from melanocytes — pigment cells producing melanin. According to the Global Cancer Observatory, melanoma of the skin is the 19th most common cancer worldwide with nearly 300 000 new cases[2]. It is reported that the number of melanoma is 10 930 with 4010 deaths per year in Russia [3], and the melanoma diagnosis is often delayed, with 19% of patients having advanced or metastatic disease at presentation[4], which leads to an unfavorable prognosis and low patient survival.

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 [5].

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.

“We are pleased that BIOCAD can offer a new option for the treatment of patients with inoperable or metastatic melanoma. Progolimab is a unique drug in terms of its structure: it is the first PD-1 inhibitor based on IgG1 monoclonal antibodies with additional modifications of its effector properties. Registration of the first original PD-1 inhibitor in Russia was an important stage in the development of immuno-oncology and treatment of patients with malignant neoplasms,” said Dmitry Morozov, BIOCAD CEO.

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[1] Tjulandin S., Fedyanin M., Moiseenko V. et al. Final results of phase II trial (MIRACULUM) of the novel PD-1 inhibitor prolgolimab in patients with advanced melanoma. Annals of Oncology (2019). https://www.annalsofoncology.org/article/S0923-7534(20)34505-1/fulltext

[2] Melanoma of Skin. Global Cancer observatory https://gco.iarc.fr/today/data/factsheets/cancers/16-Melanoma-of-skin-fact-sheet.pdf

[3] Russian Federation Factsheet. Global Cancer Observatory https://gco.iarc.fr/today/data/factsheets/populations/643-russian-federation-fact-sheets.pdf

[4] State of Oncological Care for the Population of Russia in 2018
https://nnood.ru/wp-content/uploads/2019/04/Statichticheskijj-ezhegodnik-Gercena-2018.pdf

[5] Immune Checkpoint Inhibitors Market

https://www.researchandmarkets.com/reports/4901457/immune-checkpoint-inhibitors-market?utm_source=dynamic&utm_medium=BW&utm_code=745glk&utm_campaign=1349268+-+Immune+Checkpoint+Inhibitors+Markets%2c+2011-2019+%26+2020-2025&utm_exec=joca220bwd

BIOCAD is among the biggest Russian companies that take biotechnology and innovation to an international level. It unites R&D centers of highest standard, modern pharmaceutical and biotechnological factory, clinical and pre-clinical research that meets international requirements.

BIOCAD is a fully integrated company dedicated to new drugs development on all stages: from search for a molecule to mass production and marketing support. The drugs produced are mainly targeted at cancer and autoimmune diseases treatment. Nowadays, portfolio includes 58 ready products and over 40 are still at various stages of development.

BIOCAD team unites more than 2700 employees, one third of which are researchers and scientists. The company is represented in Brazil, China, Vietnam, UAE and other countries.

Source: BIOCAD press office, https://biocadglobal.com/