A study carried out by researchers at Einstein Israelita Hospital and funded by the Ministry of Health has shown promising results for patients with leukemia and B-cell lymphomas using CAR-T therapy.
Considered one of the most promising techniques to treat blood (hematological) cancers, research with CAR-T is the first approved by Anvisa (National Health Surveillance Agency) and carried out entirely in Brazil.
The method involves taking the patient’s blood, modifying the defense cells (T lymphocytes) so that they identify and destroy the cancer, multiplying them in the laboratory and then reintroducing them into the body, allowing the body itself to fight the tumor. The process is completely personalized and performed only once.
“This is the first time the pharmaceutical industry has done something different. They don’t take a commercial drug and give it to the patient. They take the patient’s cells at the hospital, send them and process them in a factory so that they turn against the tumor,” explains Nelson Hamerschlak, coordinator of Einstein’s hematology department and one of the authors of the study.
Phase 1 data from the Carthiae study shows that, of the 11 patients treated, 81% had some response, and 72% had a complete response, even after multiple prior treatments.
One year after the intervention, 71% of patients are alive and without progression of the disease. The results were presented at the American Society of Hematology (ASH) Annual Meeting, held in Orlando, Florida, USA, from December 6-9.
The Ministry of Health invested 31.9 million reais in the study. The resource provides for the execution, monitoring and follow-up of trials, “with the aim of expanding the scientific, technological and productive capacity of the country with the development of allogeneic therapies.”
In a note, the ministry said it would invest 542 million reais to structure a national cell therapy network, including CAR-T, to expand the country’s production capacity and infrastructure.
According to the ministry, for the technology to be widely integrated into the SUS (Unified Health System), it is necessary to obtain registration with Anvisa and approval from Conitec (National Commission for the Incorporation of Technologies into the SUS), which analyzes evidence of effectiveness, safety and cost-effectiveness.
In addition to the Einstein study, four other CAR-T projects are progressing in Brazil: USP (University of São Paulo) Ribeirão Preto, Butantan Institute, Fiocruz/Inca (Fundação Oswaldo Cruz/National Cancer Institute) and UFC (Federal University of Ceará). However, all are still in the preliminary stages, under negotiation or awaiting approval from Anvisa.
Einstein’s Carthiae research examined 18 patients, but seven were excluded because they did not have active disease. Of the remaining 11, 72.7% were men, with an average age of 42, from the North, Northeast and Southeast regions of Brazil. Each person had already undergone an average of four unsuccessful treatments. The study plans to include 30 additional patients by the middle of next year.
The technique used by Einstein is to make service pointwhen the patient’s cells are collected, multiplied and reintroduced into the body in the same institution, thereby reducing costs.
According to Hamerschlak, standard commercial treatment with CAR-T costs between US$300,000 and US$400,000, with additional hospitalization costs ranging from US$100,000 to US$200,000, for a total of US$400,000 to US$600,000 (2 to 3 million reais).
Indeed, the process requires sending the patient’s cells to centers in the United States or Europe, with complex storage steps.
“As the cell is collected, processed and returned to the patient in the institution here in Brazil, our cost varies between 10 and 20% of the standard cost,” he says.
In other words, the process can be 80-90% cheaper, ranging from R$200,000 to R$600,000. This helps reduce costs and dependence on imported technologies, one of the main obstacles to wider use of this type of treatment in Brazil and middle-income countries.
“Having this low-cost line is very important. Ultimately, patients in both the public and private system can benefit from it,” says Hamerschlak.
In addition, carrying out the entire process in Brazil is faster. In the research, the cell multiplication stage in the laboratory lasted 12 days, with a maximum “vein to vein” time, i.e. from collection to reinfusion, of 22 days. The success rate of this multiplication was 100%, an uncommon indicator even in international centers.
According to the study coordinator, in standard processing, which depends on shipping to another country, this time can reach 40 days. “If the patient progresses, that’s a problem.”
The journalist came at the invitation of Johnson & Johnson.
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