Innovative immunotherapy for lung cancer authorized in Russia

The Ministry of Health of the Russian Federation has approved the PD-1 inhibitor Areima^® (INN: camrelizumab) for the treatment of non-small cell lung cancer (NSCLC). The product will be manufactured by Petrovax Pharm under a full-cycle production model in partnership with the N. F. Gamaleya National Research Center of Epidemiology and Microbiology, including active substance synthesis. According to the results of a pharmacoeconomic study, the introduction of the new product may enable cost savings of up to RUB 7.5 billion compared with alternative PD-1/PD-L1 inhibitors^[1].

In Russia, the incidence of cancers of the trachea, bronchi, and lung continues to increase^[2]. In most cases, these diseases are diagnosed at advanced stages (III–IV) and are associated with high mortality and a substantial burden on the healthcare budget^[2]. Therefore, experts emphasize the importance of expanding access to immunotherapy for lung cancer patients and reducing the cost of treatment^[1].

The launch of camrelizumab in the Russian market in 2024 became a major breakthrough in the treatment of esophageal cancer and nasopharyngeal cancer. Experts note^[3] that this next-generation checkpoint inhibitor demonstrates clear advantages over first-generation agents in the class, due to its high affinity and selective, targeted binding to the PD-1 protein. These features contribute to a meaningful improvement in prognosis for patients.

The product has been recommended for inclusion in the List of Vital and Essential Medicines (Essential Drug List, EDL) and in clinical guidelines for a number of oncology indications^{[4], [5]}. In addition, it has been included in RUSSCO practical guidelines^[6] as a first-line and subsequent-line therapy option for esophageal cancer, as well as the preferred first-line regimen for nasopharyngeal cancer^[7]. Petrovax Pharm continues to explore additional therapeutic opportunities for camrelizumab and, together with the Gamaleya Center, is participating in the development of an mRNA-based technological platform for developing combination treatments across oncology indications^[8].

Background Information

Areima^® (camrelizumab) is an immuno-oncology medicine approved in Russia for the treatment of locally advanced and metastatic squamous cell carcinoma of the esophagus in combination with paclitaxel and cisplatin; treatment of recurrent or metastatic nasopharyngeal carcinoma in combination with cisplatin and gemcitabine; first-line treatment of locally advanced or metastatic non-squamous NSCLC without EGFR or ALK mutations in combination with pemetrexed and carboplatin; first-line treatment of locally advanced or metastatic squamous NSCLC in combination with paclitaxel and carboplatin. Camrelizumab is a monoclonal antibody targeting the PD-1 receptor, which reactivates tumor-specific cytotoxic T cells and stimulates antitumor immunity. The drug has been studied in more than 33 clinical trials, including in Russia^{[4], [5]}. Clinical practice includes over 300,000 patients treated with camrelizumab worldwide.