A joint venture between the biotechnology company BIOCAD and Shanghai Pharmaceuticals Holding has announced the enrollment of the first patient in a trial of the original immuno-oncology drug prolgolimab in China. The international clinical study BCD-100/FERMATA is being conducted in patients with advanced cervical cancer.
The international, randomized, double-blind clinical study BCD-100/FERMATA was approved in February this year by China’s Center for Drug Evaluation of the National Medical Products Administration (CDE of NMPA). The study is aimed to evaluate the safety and efficacy of prolgolimab (BCD-100) in combination with platinum-based chemotherapy and with/without bevacizumab versus placebo in combination with platinum-based chemotherapy and with/without bevacizumab in patients with advanced cervical cancer. The BCD-100/FERMATA study is being conducted in China and Russia; a total of 380 patients are to be enrolled in the study, including 64 in China; the recruitment of participants should be completed by the end of 2022. The clinical study in China is being conducted by SPH-Biocad (HK) Ltd., a co-sponsor of the international prolgolimab clinical research program. In the PRC, the study is expected to be completed in late 2025.
According to the World Health Organization (WHO), 59,600 women died from cervical cancer in China in 2020. During the same period, 109,741 new cases of the disease were diagnosed in the country.
This is the second study of the Russian originator in China; enrollment of patients with non-small cell lung cancer in the prolgolimab study BCD-100-3/DOMAJOR is ongoing since September this year. More than $ 20 million will be invested in both studies in China. The total joint venture financial investment in international multicenter clinical trials (IMCTs) of the drug may exceed $ 35 million.
Prolgolimab is a monoclonal antibody that binds to the PD-1 programmed death receptor and blocks its interaction with the PD-L1 and PD-L2 ligands. Prolgolimab is an immunoglobulin. The Fc fragment of prolgolimab is modified to prevent cytotoxic effects on lymphocytes expressing PD-1. In Russia, prolgolimab is approved for the treatment of unresectable or metastatic melanoma. It is also included in the list of vital and essential drugs (LVED) and the clinical guidelines Melanoma of the Skin and Mucous Membranes.
In China, there has been an increase in the number of studies of PD-1/PD-L1 inhibitors and their combinations with other drugs; there is a high demand for these inhibitors in the market. Thanks to the country’s patient assistance programs, Chinese patients pay a small fraction of the cost of cancer drugs, with a large share of the cost (2.44 trillion yuan or $ 373 billion) being covered by China’s Social Health Insurance Fund, which helps 95% of the country’s population.