A patient undergoing cancer treatment for 13 years has achieved complete remission of the tumor after participating in a study with an innovative therapy known as CAR-T cell therapy.
The positive result was confirmed on Sunday (28) when the patient was discharged from the Hospital das Clínicas da Faculdade de Medicina da USP (HC-FMUSP) in São Paulo.
Paulo Peregrino, 61, had previously tried conventional therapies such as chemotherapy and surgery to remove the tumor but had been unable to rid himself of the disease, a non-Hodgkin lymphoma, which was diagnosed in 2018, about eight years after detecting prostate cancer.
As there was no regression of the cancer, the patient would have started receiving palliative care when he was admitted to the Center for Cellular Therapy at HC for compassionate use. This practice is adopted when no other approach is possible, and therapies still under study are used in an attempt 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 already very debilitated, with advanced cancer, intense pain, and a low platelet count, indicating that his health was severely affected,” explains hematologist Vanderson Rocha, professor of cellular therapy at the Faculdade de Medicina da USP and national coordinator of cellular therapy for the Rede D’Or. He was in charge of Peregrino’s case at the center.
CAR-T cells are immune system cells (known as T lymphocytes) extracted 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 and attacking the cancer focus.
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The therapy has been successful in treating certain types of blood cancer, lymphomas, and leukemias, but its efficacy against solid tumors has not been proven. In such cases, chemotherapy, radiation therapy, or treatments like immunotherapy tend to be more effective.
“It is necessary to follow up for a period of up to five years to confirm whether there has been ‘cancer cure,’ but studies conducted in the United States have shown that around 50% of lymphoma patients are cured with CAR-T,” he said.
The entire process, according to Rocha, took about four months, including three months for cell collection, approval, and clearance of the technique by the National Health Surveillance Agency (Anvisa) and the National Committee of Ethics in Research (Conep).
The Nutera (Núcleo de Terapia Avançada) has two centers, one in São Paulo, opened last year, and another in Ribeirão Preto (SP). The center was built with the support of the São Paulo Research Foundation (FAPESP) and the National Council for Scientific and Technological Development (CNPq), linked to the Ministry of Science, Technology, and Innovation (MCTI), and has researchers from USP and the Butantan Institute.
CAR-T therapy is an innovative treatment that has shown promising results in the treatment of certain types of cancer, such as B-cell leukemias, lymphomas, and multiple myeloma. Currently, in Brazil, CAR-T therapy is only authorized by the National Health Surveillance Agency (Anvisa) in compassionate use cases, which means when no other treatment options are available.
In a study conducted at the Hospital das Clínicas of the University of São Paulo in São Paulo, a 61-year-old patient with non-Hodgkin lymphoma achieved complete remission of the tumor after receiving CAR-T therapy.
This patient had already tried other conventional therapies such as chemotherapy and surgery without success.
CAR-T therapy involves the genetic modification of the patient’s immune system cells, called T cells, so that they can recognize and attack cancer cells. These modified cells are then reintroduced into the patient, becoming more effective in fighting cancer.
Although CAR-T therapy has shown success in the treatment of certain types of blood cancers such as leukemias and lymphomas, there is still no proven efficacy against solid tumors. However, studies conducted in the United States have shown that about 50% of lymphoma patients have been cured with the use of CAR-T therapy.
The cost of this therapy is high, reaching approximately R$ 2 million per patient in the private market. However, the possibility of producing CAR-T cells in a public research institute in São Paulo may make this innovative technique available to the entire Brazilian population free of charge through the Unified Health System (SUS).
The director of the Butantan Institute emphasizes that this research positions Brazil as a prominent producer of innovative therapies and can drive biotechnological advancement in the country.
A combined phase 1/2 clinical trial with 75 patients is scheduled to begin by the end of the year, and one of the challenges for the continuation of research is the high cost of the clinical trial and production at scale. Currently, some large pharmaceutical companies have off-the-shelf CAR-T cell options in their portfolio, which are donor-derived modified CAR-T cells that can be applied to any patient. However, these options come with high costs and there is a risk of incompatibility.
It is expected that investments of around R$ 60 million in the research phase could result in savings of more than R$ 140 million for the healthcare system compared to the prices of the medication in the private market. This research highlights the importance of seeking national solutions and reducing dependence on foreign supply chains, especially when product prices become exorbitant.