Biocad: Nurdati (melanoma drug)

The main articles are:

• Melanoma
• Drugs to treat cancer

2024

Empegfilgrastim in Cancer Patients

The first interim results of the clinical study to evaluate the effectiveness of the Russian drug for the treatment of melanoma developed by BIOCAD are presented. The company announced this on September 30, 2024. The study evaluates the contribution of the neoadjuvant stage of combined immunotherapy with nurulimab and prolgolimab (Nurdati) to achieving a pathomorphological response in patients with stage III melanoma at high risk of relapse, as well as to assessing the safety of this treatment. Achieving a pathomorphological response (complete disappearance of tumor cells) may indicate a significant reduction in the risk of recurrence and an increase in the chances of remission.

The first analysis of the study included 108 participants, of whom 57 were treated with combined therapy with nurulimab and prolgolimab (Nurdati).

At the time of the data cut, 75% of participants were assessed for pathomorphological response. Of these, 51% achieved a complete or almost complete pathomorphological response.

The safety profile was expected for this class of drugs and revealed no new unexpected side effects. No subjects discontinued due to adverse events.

This method of treatment can improve the quality of life of patients, reducing the need for surgery and associated risks. The study indicates that two courses of therapy with the combination drug nurulimab and prolgolimab (Nurdati) may be effective for a significant number of patients.

Inclusion in VED list

The Commission of the Ministry of Health included the original drug "Nurdati," developed by scientists of the biotechnological company BIOCAD, in the list of vital and essential drugs (VED). This solution opens up access to innovative therapies for more than 550 patients. Biocad announced this on August 23, 2024.

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Biocad

Nurdati is a monoclonal antibody drug created to treat patients with melanoma, including cases with metastases. The drug was developed and manufactured completely in Russia, the biotechnological company BIOCAD invested more than 1.4 billion rubles in its development.

The inclusion of an original domestic drug in VED allows for stable access to innovative therapy without the risk of interruptions, which is especially important for maintaining their health and ability to work. noted N.P. Dronov, Chairman of the Coordination Council of the MOD "Movement Against Cancer," member of the Council of Public Organizations for the Protection of Patients' Rights under the Ministry of Health of Russia.

The efficacy of Nurdati has been evaluated in clinical trials. The results of the comparative study, published in the journal Modern Oncology, show that Nurdati (a combination of nurulimab and prolgolimab) with continued prolgolimab therapy is superior to prolgolimab monotherapy in patients with unresectable or metastatic melanoma.

The number of potential patients who can receive treatment at 100% security is more than 12 thousand patients. The clinical study showed a stable effect of the drug in patients with unresectable and metastatic stage III-IV melanoma. Additionally, after the Nurdati course, the patient receives an average of 16 injections of Forteca (Prolgolimab), which is also included in the clinical guidelines.

The inclusion of the Russian drug in the VED list corresponds to the course of development of national priorities aimed, countries among other things, at increasing the availability of advanced medicines for Russian patients.