BIOCAD expands indications for a Russian anti-cancer originator

The Ministry of Health of the Russian Federation has authorized prolgolimab for the treatment of lung cancer, expanding the current list of indications. Authorization of the new indication was based, among other things, on the results of the BCD-100-3/DOMAJOR Phase III clinical trial.

BIOCAD, a biotechnology company, was granted an authorization for its originator prolgolimab for the indication of non-small cell lung cancer; the new indication was included in the Marketing Authorization by the Ministry of Health of the Russian Federation. The safety and efficacy of the product for the new indication was studied as part of an international multicenter, randomized, double-blind, placebo-controlled clinical trial of BCD-100 (prolgolimab) in combination with pemetrexed + cisplatin/carboplatin versus placebo in combination with pemetrexed + cisplatin/carboplatin as the first-line therapy in patients with advanced non-squamous non-small cell lung cancer. The trial included 292 patients from Russia, China, and the European Union. The DOMAJOR trial lasted for more than four years; the company's investment in clinical development and research amounted to over 1.4 billion rubles (app. USD 154 mln).

During the trial, the product showed an acceptable safety profile, with a significant reduction in mortality. Objective disease control was achieved in the vast majority of patients in the prolgolimab-containing treatment group, with overall and progression-free survival being non-inferior to the best available current options.

“The trial demonstrated the superiority of prolgolimab in combination with pemetrexed + cisplatin/carboplatin as the first-line treatment of advanced non-squamous non-small cell lung cancer with an acceptable safety profile. Clinical benefit was observed regardless of the level of PD-L1 expression in the tumor, patient age, ECOG status, smoking status, or the presence of brain metastasis or histological tumor type,” said Konstantin Konstantinovich Laktionov, Professor, MD, DSc (Med), First Deputy Director, Head of the Department, Oncologist at N. N. Blokhin Russian Cancer Research Center.

Prolgolimab is the first Russian PD-1 inhibitor originator; it is a monoclonal IgG1-type antibody with a modified Fc fragment. PD-1 inhibitors are able restore the T cell ability to recognize and destroy malignant cells, as a result of which the human immune system starts fighting the tumor. In April 2020, the product was authorized for the treatment of metastatic melanoma and proved well in real-world practice. Within two years, the product was authorized in Belarus and Kazakhstan, and clinical trials are currently ongoing in China. Also, the FERMATA Phase III clinical trial is ongoing, where the product performance for the indication of cervical cancer is studied.