Nanolek has completed the first stage of localization of a drug to treat intractable forms of blood cancer

2.07.21 Russian biopharmaceutical company Nanolek has completed the first stage of localization of the drug Darzalex® (INN daratumumab) - the secondary packaging and quality control stage. Nanolek’s partner in the project is Janssen, the pharmaceutical division of Johnson & Johnson LLC. Darzalex is the fourth drug in Nanolek’s oncological portfolio, and this area is one of the priorities for the company. Darzalex® is localized at the Nanolek plant in the Kirov region, which operates in accordance with international GMP and ISO standards.

“Since 2020, daratumumab has been included in the list of drugs for the treatment of diseases that belong to high-cost nosologies (HCN). According to our estimates, the annual demand for the drug under the HCN program is about 55,000 units per year. Nanolek will provide this entire amount, and, together with our partner, we are ready to scale up production to ensure access to this drug for all patients with multiple myeloma to whom it is indicated and for whom it is purchased under the program. We believe that localization is contributing and will contribute to the expansion of the drug’s use in clinical practice,” says Vladimir Khristenko, President of Nanolek.

Daratumumab is the first biological drug in its class to target the surface protein CD38, which is largely expressed on all myeloma cells, regardless of the stage of the disease. Globally, Darzalex® (daratumumab) has been approved for treatment in patients with multiple myeloma (MM) since 2016.

In Russia, the drug was registered in 2017 as a monotherapy for adult patients with recurrent and refractory multiple myeloma who had previously received a proteasome inhibitor and an immunomodulatory drug, and who had experienced progression of the disease during the last course of treatment.

Since 2019, the list of indications has been expanded, and the drug has been used for combination therapy in adult patients with MM, starting fr om the first line of therapy2.

According to the results of clinical studies, daratumumab showed good tolerability (adverse events include infusion reaction and anemia, while patients, as a rule, do not have to interrupt therapy), as well as high clinical efficacy in all lines of MM therapy for adult standard and high risk patients, leading to a significant reduction in mortality in patients receiving daratumumab-based therapy regimens, which is in line with national policy priorities to reduce mortality and increase life expectancy. So, in patients who are not candidates for transplantation, the addition of daratumumab to the Rd regimen (lenalidomide, dexamethasone) according to the MAIA clinical trial in the 1st line of MM treatment provides a 5-year overall survival (OS) rate in 66% of patients, and MM recurrence, according to the POLLUX clinical study, a 3.5-year OS in 65%, a third higher than when using the Rd regimen3,4.

The daratumumab therapy regimen in combination with VMP (melphalan, bortezomib, prednisolone) in the 1st line of MM treatment provides a 3-year OS in 78% of patients, an improvement of 40% compared to the VMP regimen5.

And when using the DVd regimen (daratumumab, bortezomib, dexamethasone) in patients with recurrent MM, the 3-year OS is 61%, which is an improvement of 22% compared to the Vd regimen6, 7.

On the availability of financing for malignant blood diseases

In April - May 2021, the Mar Consult research company conducted a study among Russian oncohematologists. According to its results, 26% of oncohematologists reported difficulties with drug provision, and 29% of those surveyed believe that innovative treatments are not available in Russia. The All-Russian Society of Oncohematology Sodeystvie conducted a survey among 788 patients fr om 76 regions of Russia, which showed that since the beginning of the pandemic, more than 60% of patients find it difficult to see a doctor, and 75% have not received the necessary treatment. Furthermore, in the case of multiple myeloma, the patient is indicated drugs throughout their life.

The localization of oncohematological drugs will help to solve the difficulties with the lack of drugs. Such projects are in line with the federal program National Strategy for the Fight against Cancer Diseases. At the second international Forum of Oncology and Radiology, the ex-Minister of Health of Russia Veronika Skvortsova said: “Reducing mortality from cancer is top priority for the state, which involves not only the medical community, but also the authorities.” According to the Minister of Health of the Russian Federation Mikhail Murashko, thanks to the federal project Fight against Cancer, in 2020 the cancer mortality rate was reduced by 1.5%.

About multiple myeloma

Multiple myeloma (MM) is an incurable malignant blood disease that begins in the bone marrow and is characterized by excessive proliferation of plasma cells. MM is the second most common malignant blood disease. Almost 29% of patients with MM die within one year of the diagnosis of the disease1.

According to the National Cancer Institute (USA), this disease accounts for 1,8% of all oncological diseases, in Russia, in 2017, the number of patients with multiple myeloma was 2.78 per 100,000 people. This is the second most common tumor of the hematopoietic system … According to the American Cancer Society, middle-aged and elderly people are at risk: only 1% of cases of the disease occur in patients under 35 years of age. In the N.I. Pirogov Russian National Research Medical University they believe that the emergence of new drugs and the possibility of the autologous transplantation of hematopoietic stem cells (auto-HSCT) have increased the chances of Russian patients with multiple myeloma of surviving five years: since 2000, it has grown from 21 to 48%.

For information:

Darzalex® is the first fully human monoclonal antibody that acts on the surface protein CD38, which is largely expressed on all myeloma cells, regardless of the stage of the disease. The innovative action mechanism of the drug Darzalex® involves several mechanisms that cause the rapid death of tumor cells. Darzalex® induces the destruction of myeloma cells due to CD38-mediated immune mechanisms (complement-dependent cytotoxicity, antibody-dependent cell-mediated cytotoxicity and antibody-dependent phagocytosis), apoptosis and the modulation of the enzymatic activity of CD3852.

Nanolek is a modern biopharmaceutical company founded in 2011 by Vladimir Khristenko and Mikhail Nekrasov. It specializes in the production of import-substituting and innovative medicines, both of its own design and developed with the involvement of international partners. It is a leader in the production of pediatric vaccines in the Russian Federation. In addition to vaccines, the portfolio includes drugs for the treatment of HIV, cancer and orphan diseases.

About Janssen, Johnson & Johnson Pharmaceuticals

At Janssen, we are creating a future wh ere disease is a thing of the past. We are Johnson & Johnson pharmaceutical companies, and we are sparing no effort to make this future a reality for patients around the world. We are winning the fight against disease with cutting-edge science. We invent ways to help those who need help. We heal hopelessness with human warmth.

We work in the areas of medicine wh ere we can bring the greatest benefit: cardiovascular diseases, immune-mediated diseases and metabolic disorders, infectious diseases and vaccines, diseases of the central nervous system, oncology, and pulmonary arterial hypertension.

References:

  1. 1. Online resource: http://cr.rosminzdrav.ru/#!/schema/122. Categories of clinical guidelines “Multiple myeloma. ID КР144, age category: adults”// Ministry of Health of Russia, 2020, accessed 27 May 2021
  2. Instructions for the medical use of the drug DARZALEKS, LP-004367 date of last update 05 December 2019
  3. Thierry Facon, Presented on ASCO 2021. Oral presentation. LB1901
  4. Bahlis N.J. et al. Leukemia. 2020 Jan 30. DOI: 10.1038/s41375-020-0711-6
  5. Mateos M et al. Lancet 2020 Jan 11;395(10218):132-141.
  6. Spencer A, American Society of Hematology, 2017.
  7. Katja C. Weisel, Blood (2019) 134 (Supplement_1: 3192.https://doi.org/10.1182/blood-2019-123527