CAR-T leads to total remission of cancer patient in SP – 05/29/2023 – Health

CAR-T leads to total remission of cancer patient in SP – 05/29/2023 – Health


A patient undergoing cancer treatment for 13 years experienced complete tumor remission after being part of a study with an innovative therapy known as CAR-T cells.

The positive result was confirmed this Sunday (28), when he was discharged from the Hospital das Clínicas of the Faculty of Medicine of USP (HC-FMUSP) in São Paulo.

Paulo Peregrino, 61, had already tried conventional therapies, such as chemotherapy and surgery to remove the tumor, but had not been able to get rid of the disease, a non-Hodgkin lymphoma, whose diagnosis came in 2018, about eight years after detecting a cancer of the prostate.

As there was no regression of the cancer, the patient would start palliative care when he was admitted to the Cell Therapy Center, at HC, for the so-called compassionate use. This practice is adopted when there is no other approach possible and therapies still under study are used to try to save the patient’s life.

“What was extremely encouraging is that we saw a positive response in just one month in a patient who arrived at the center very weak, with very advanced cancer, complaining of severe pain and low platelet count, indicating that he was in good health. affected”, explains hematologist Vanderson Rocha, professor of cell therapy at the USP Faculty of Medicine and national coordinator of cell therapy at Rede D’Or. He handled Peregrino’s case at the center.

CAR-T cells are immune system cells (known as T lymphocytes) taken from the patient and genetically modified to recognize and attack tumor cells. They are then reintroduced into the patient and become more effective in identifying the cancerous focus and attacking it.

The therapy has been successful in the treatment of some types of cancer of the blood system, lymphomas and leukemias, but there is no proof of effectiveness against solid tumors. In these cases, chemotherapy, radiotherapy or treatments such as immunotherapy tend to be more effective.

“It is now necessary to follow up for a period of up to five years to confirm whether there was a ‘cure’ for the cancer, but, in studies carried out in the United States, around 50% of lymphoma patients are cured with CAR-T”, he said. .

The whole process, says Rocha, took about four months, three of which for the collection of cells, approval and release of the technique by Anvisa (National Health Surveillance Agency) and Conep (National Research Ethics Committee).

Nutera (Advanced Therapy Nucleus) has two centers, one in São Paulo, opened last year, and another in Ribeirão Preto (SP). The center was built with support from FAPESP (São Paulo State Research Support Foundation) and CNPq (National Council for Scientific and Technological Development), linked to MCTI (Ministry of Science, Technology and Innovation), and has researchers from USP and the Butantan Institute.

Currently, CAR-T therapy is only authorized by Anvisa from patient to patient, that is, in the form of compassionate use when there is no other method available. It is also primarily used to treat type B leukemias, lymphomas (such as non-Hodgkin’s lymphoma), and multiple myeloma, a type of blood cancer.

In 2019 there was the first patient treated, a 62-year-old man, also with non-Hodgkin lymphoma, but he ended up suffering a fall and died as a result of head trauma.

A second patient, the first one treated at the HC, also showed remission of type B lymphoblastic leukemia. “Thirteen patients have already been treated, two of them in São Paulo, and the results so far have been very promising. and advanced stage of cancer”, says Rocha.

The cost of this therapy, however, is high, reaching R$ 2 million per patient at market value. “The possibility of producing CAR-T cells at a public research institute in São Paulo will certainly offer an innovative technique to combat cancer, available to the entire Brazilian population free of charge through the SUS [Sistema Único de Saúde]”, says Rocha, who expects the financial support to continue.

Esper Kallás, infectologist and director of the Butantan Institute, reinforced that the presence of an innovative center like this puts Brazil in a prominent position. “Technologies like this, which have been called ‘disruptive’ or innovative, place our country as a major producer of this type of therapy and may be central to Brazilian biotechnological advancement.”

According to him, a phase 1/2 combined clinical trial should start by the end of the year with 75 patients. The main difficulty in proceeding with research of this type is the high cost of the clinical study and then the bottleneck in scale production. “Fortunately, we have here in São Paulo a cell therapy production center that will produce these cells on a large scale”, he stated.

Currently, large pharmaceutical industries, mainly the American Gilead Sciences and Janssen (the pharmaceutical arm of Johnson & Johnson), have in their portfolio the so-called “shelf CAR-T”, that is, CAR-T cells from modified donors that can be applied to any patient, but the costs are very high, not to mention the risk of not being compatible.

The expected investment for this research phase is BRL 60 million, but it is expected that the savings will be more than BRL 140 million for the health system in relation to the price of the medicine in the private market.

“The main highlight of this research is that it leaves the lock of the big industry, which transformed the value of these products into exorbitant costs. We cannot depend 100% on the foreign supply chain, we need to look for national solutions”, said the director of the institute.



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